25 Orthopedic Startups on Our Radar

We discover dozens of orthopedic startups every year via public announcements, industry meetings, LinkedIn, FDA databases…they’re everywhere. We’ve compiled a list of 25 implant and instrument companies that are newer to our radar in hopes that it provides you with a better understanding of the latest technology on the market, perceived gaps in orthopedic care, potential competition and smart individuals to align yourself with.

Joint Replacement

1. Nela Biodynamics | Aldaia, Valencia, Spain | Founded: 2017

• Nela seeks to offer an alternative to implants that are fitted by high impact, resulting in potential complications, frequent post-surgical pain and a high percentage of implant failures.
• Modular R-Evolution technology supports a customized fit for each patient and avoids the conventional techniques based on impact press-fit or use of bone cement to achieve fixation. Implantation strength can be adapted to the patient’s bone density, improving load transmission by reducing bone loss around the implant. Applications include replacement of the shoulder, elbow, hip and knee, as well as nails to treat fractures.

Spine

2. 3Spine | Chattanooga, Tennessee, US | Founded: 2017

• Raised a total of $51.8 million in funding over four rounds, to date.
• Granted FDA Investigational Device Exemption approval for their U.S. pivotal clinical trial.
• 3Spine’s MOTUS device, the implant used in the BalancedBack Total Joint Replacement procedure, is a “first of kind” technology designed to replace the function of the disc and facet joints through a posterior approach. The procedure broadly addresses leg pain, back pain and spinal instability, while correcting posture and restoring freedom of movement through reconstruction of the functional spinal unit. MOTUS was designated a Breakthrough Device by FDA in 2020.
• Leadership brings experience from roles at Abbott Spine, DePuy Synthes/Synthes Spine, Etex, Facet Solutions, Medtronic Sofamor Danek, Ortho Development, Sulzer Orthopedics, Zimmer Biomet, Zimmer Spine.

3Spine’s MOTUS device is a “first of kind” technology designed to replace the function of the disc and facet joints through a posterior approach.

3. Accelus | Palm Beach Gardens, Florida, US | Founded: 2021 through the combination of Integrity Implants and Fusion Robotics

• Focused on providing proprietary Adaptive Geometry technology with economical navigation and robotic solutions with broad clinical use in spine surgery.
• Most recently granted FDA 510(k) clearance for Toro Lateral (Toro-L) Interbody Fusion, a biplanar expandable lateral implant with 3D-printed endplates, designed for a minimal insertion profile and maximum bone graft delivery directly through the inserter.
• Leadership brings experience from roles at Alphatec Spine, DePuy Spine, Medtronic, NuVasive, Smith & Nephew Orthopaedics, Stryker.

4. Amber Implants | Den Haag, Zuid-Holland, The Netherlands | Founded: 2018

• Raised a total of €8.8 million (~USD $9.9 million) to date, in a Series A round.
• Granted Breakthrough Device Designation by FDA in 2021 for the VCFix spinal system, reportedly the first solution to treat vertebral fractures that does not rely on bone cement. Through its 3D-printed perforated structure, VCFix aims to stimulate bone ingrowth as a more natural healing process, while providing better stability and distribution of loads in the spine.

5. Blue Ocean Spine | Tuttlingen, Baden-Württemberg, Germany | Founded: 2020

• Received an investment from medtech investor SHS in 2021.
• Developing functional and adaptable expandable 3D-printed cage systems. As an alternative to conventional spinal cages, Blue Ocean implants will permit surgeons to eliminate additional screw connections. Surgeons will also be freed from the need to maintain an inventory of a large number of implant variations in different sizes and dimensions.
• Planning to apply for FDA clearance in 2022.
• Leadership brings experience from roles at Aesculap, DePuy Synthes, Diener Implants, EIT Emerging Implant Technologies, Paradigm Spine, RTI Surgical, Spine Solutions.

6. Companion Spine | New York, New York, US | Founded: 2020

• Raised a total of $55 million to date in a Series A round, led by Viscogliosi Brothers.
• The company’s products, stemming in part from an acquisition from Medtronic in 2020 of regulatory and clinical property, include a portfolio of six patent families covering more than 140 patents, as well as an inventory of instrument and implant sets. These technologies may offer an alternative to options such as spine fusion.
• Presently, Companion Spine offers the DIAM implant to select markets. DIAM is designed for the treatment of degenerative disc disease. The device is CE Marked, and received the Breakthrough Device Designation from FDA in 2021.
• Leadership brings experience from roles at Abbott Spine, Aesculap, Exactech, Implanet, Medacta, RTI Surgical, Spine Next, Spine Solutions, Stryker, Surgalign, Synthes.

Companion Spine’s DIAM is designed for the treatment of degenerative disc disease. The device is CE Marked, and received the Breakthrough Device Designation from FDA in 2021.

7. CornerLoc | Tulsa, Oklahoma, US | Founded: 2017

• The CornerLoc sacroiliac (SI) joint stabilization procedure was designed to support stabilization and fusion potential, with minimal surgical invasiveness. After preparation of the SI joint, two CornerLoc grafts are placed orthogonally within the SI joint, creating immediate joint stability and an optimized environment for fusion. CornerLoc cortical graft plus a DBM sponge combine to reduce pain and instability within the sacroiliac joint.
• The system is the subject of a randomized, multicenter, open-label U.S. clinical trial comparing CornerLoc to steroid injections to treat SI joint dysfunction.
• Leadership brings experience from roles at DePuy Spine, HT Medical, SeaSpine.

8. HAPPE Spine | Grand Rapids, Michigan, US | Founded: 2018

• Raised a total of $5.6 million to date in funding over two rounds, including seed and Series A.
• The company’s name derives from their patented material platform: HydroxyApatite Porous PolyEtheretherketone.
• Formed by the inventors (Spinemith LLC, Indiana) in partnership with the Genesis Innovation Group with investments from cultivate(MD) to commercialize the material technology in spine.
• The HAPPE INTEGRATE™ interbody fusion system is reported to be the first to combine the advantages of interconnected cancellous porosity for bone ingrowth, bioactive surfaces for bone ongrowth, radiolucency for post-operative imaging, and bone-like mechanical properties in one implant.
• Leadership brings experience from roles at Genesis Innovation Group, Globus, Medicrea, Medtronic, Spinal Simplicity, Stryker, Tornier.

9. Kleiner Device Labs | Incline Village, Nevada, US | Founded: 2013

• Raised a total of $6.2 million to date in pre-seed and seed funding over four rounds.
• In 2018, the company introduced KG 1, a disposable single-use bone graft delivery tool for spinal procedures. The KG 2 Surge Flow-Thru interbody followed with initial launch in 2022; the device is designed to maximize total bone graft delivery volume and better distribute graft bilaterally into the intervertebral disc space.
• Surgeon-founded, and leadership brings experience from roles at Aegis Spine, Biomet, Cayenne Medical, Lanx, Moximed, SI-BONE, Vertiflex, Zimmer Biomet.

10. VySpine | Tallahassee, Florida, US | Founded: 2020

• Full-line spine company focusing on ASCs and small hospitals.
• In 1Q22, gained FDA 510(k) clearance for VySpan Posterior Cervical Thoracic, ClariVy Cervical IBF and LumiVy Lumbar Interbody Fusion. The latter two systems are made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced
• Leadership brings experience from roles at Alphatec Spine, Amplify Surgical, LinkSPINE, Pioneer Surgical Technology.

11. Waypoint Orthopedics | Philadelphia, Pennsylvania, US | Founded: 2020

• Raised a total of $2.3 million to date in funding over three rounds, including seed and Series B.
• Developed Waypoint GPS, a fully disposable, single-use pedicle probe that provides real-time visual feedback of the location of the cutting edge of the probe. This feedback can help physicians identify the location of the probe in the pedicle as they advance it, avoiding cortical breaches and reducing the radiation required during traditional surgery. Proprietary color sensing technology indicates the difference between cancellous and cortical bone, preventing cortical breaches. Waypoint GPS looks and feels like a standard re-usable pedicle probe and requires little change technique.
• Surgeon-founded, and leadership brings experience from roles at Core Essence Orthopaedics, DePuy Synthes, PONTiS Orthopaedics, Toetal Solutions, Trice Medical.

12. ZSFab | Cambridge, Massachusetts, US with a facility in Beijing, China | Founded: 2017

• Focused on patient-matched as well as customized medical implants, surgical guides and other additively manufactured end-use products, and is developing solutions by integrating proprietary algorithms, advanced modeling and optimization methods and 3D printing technologies for healthcare and related areas.
• In 2021, ZSFab was granted FDA 510(k) clearance to market its first 3D-printed cervical interbody.

Trauma

13. ActivOrtho | Plymouth, Minnesota, US | Founded: 2017

• Raised a total of $2.6 million to date in pre-seed and seed funding over five rounds.
  Focused on an alternative to fixed length rigid implants, which may lead to loss of compression during bone realignment or remodeling.
• Company’s proprietary technology is designed to apply Active Compression throughout the healing process to promote more rapid bone healing and a decrease in nonunion.
• Received FDA 510(k) clearance in 2021 for Nitinol Compression Screw and Continuous Compression Screw.
• Leadership brings experience from roles at Biomet, Disc Dynamics, Integra LifeSciences, Medartis, Tornier, Zimmer Biomet.

14. Magnesium Development Company (MDC) | Grand Rapids, Michigan, US | Founded: 2014

• Raised a total of $1 million in funding over two rounds, including seed and Series A.
• Granted FDA’s Breakthrough Device Designation for HC Screw in early 2022.
• MDC is developing implants utilizing BioMg 250, a patented alloy composition that contains a unique blend of magnesium and other elements, all of which are essential for healthy bone formation. MDC’s proprietary alloy does not make use of rare earth elements, and accomplishes the objectives for the material technology through a combination of alloying and mechanical formation processes.
  The alloy’s radiolucency is similar to cortical bone and does not produce imaging artifacts that are common with other metallic implants.
• Targeted devices may include devices for repair and reconstruction of foot and ankle conditions, as well as sports medicine applications.
• Leadership brings experience from roles at Biomet, cultivate(MD), DePuy Synthes, DVO Extremity Solutions, Genesis Innovation, Kinetikos Medical, Shoulder innovations, Tornier, Zimmer.

Magnesium Development Company (MDC) focuses on applying magnesium alloy to musculoskeletal implants, specifically foot and ankle and sports medicine indications. Their proprietary magnesium alloy technology and manufacturing method allow for high-strength, controlled absorption with a mechanical strength at least two times that of PEEK.

15. Medical Magnesium | Aachen, North Rhine-Westphalia, Germany | Founded: 2015

• Raised a total of $700,000 in one seed round.
• Developing metallic bioabsorbable implants using magnesium-based mm.X technology. As the devices are designed to absorb into the body post-healing, the need for implant removal is obviated.
• According to the company, mm.X allows an almost unlimited variety of designs that offer high stability vs. polymers, that are suitable for minimally invasive and arthroscopic treatments.
• Products developed to date include interference screws, suture anchors, compression screws and a PIP implant for surgical treatment of hammer or claw toe, as well as a foot fracture system.

Sports Medicine

16. Amplicore | Mason, Ohio, US | Founded: 2019

• Raised a total of $4 million to date over one seed round.
• Amplicore is pursuing a regenerative approach to treat joint osteoarthritis, cartilage damage, degenerative disc disease and acute meniscus tear. AM1101 injectable is in development as a treatment for osteoarthritis designed to reduce pain, inhibit cartilage degradation and promote tissue regeneration of aberrant cartilage. AM3101 technology has demonstrated promising preclinical results as a potential minimally invasive and regenerative approach to managing soft tissue injury.
• Leadership brings experience from roles at Tissue Regeneration Systems.

17. Lazurite | Cleveland, Ohio, US | Founded: 2015 (as Indago; rebranded in 2021)

• To date, raised a total of $15.8 million over six rounds, including seed, venture, debt financing and non-equity assistance.
• In early 2022, granted FDA 510(k) clearance for the ArthroFree Wireless Camera.
• ArthroFree incorporates proprietary low-heat, high-intensity Meridiem light technology along with advanced camera, battery and wireless transmission technologies. It is designed to deliver improved operating room productivity, patient safety and economic value through cost savings, energy efficiency and reduced setup/breakdown times. The modular system also is designed to be drop-in compatible with patient data consoles, surgical displays and endoscopes found in minimally invasive operating rooms.

ArthroFree incorporates proprietary low-heat, high-intensity Meridiem light technology along with advanced camera, battery and wireless transmission technologies.

18. Orthox | Abington, Oxfordshire, United Kingdom | Founded: 2008

• Raised a total of $36 million in funding over 15 rounds, including grants, venture round, convertible note and Series A.
• FibroFix technology is a tissue scaffold based on fibroin, a tissue regenerative protein extracted from silk fibers. The implants remove only damaged tissue, employing bone-sparing, minimally invasive surgical techniques to support rapid patient rehabilitation.
• FibroFix treats injuries to the articular cartilage in the knee, which are often sports-related. It protects the surface of these bones and allows the joint to operate smoothly. The procedure offers an alternative to debridement and microfracture.

19. TendoNova | Atlanta, Georgia, US | Founded: 2017

• Raised a total of $497,900 in funding over six rounds, including grants, seed and Series A.
• Developing a suite of affordable, specialized tools for minimally invasive orthopedic procedures that can be performed under ultrasound guidance in the physicians’ office.
• In early 2022, granted FDA 510(k) clearance for the Ocelot surgical tool, which performs mechanical fragmentation or debridement of a targeted area. Ocelot is slated for launch in 2H22.
• TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes.

Orthobiologics

20. A.D.A.M. Bio Printing | Stamford, Connecticut, US | Founded: 2018

• Raised a total of $469,000 to date in funding over three rounds, including seed rounds.
• A.D.A.M. develops an on-demand personalized implant manufacturing infrastructure with a full scope of related services, provided remotely or onsite.
• A.D.A.M. employs biopolymer and calcium-based minerals to print bones, which are made to measure based on patients’ CT scans. The 3D-printed implants stimulate natural bone growth and gradually biodegrade, eventually being replaced by the patient’s bone tissue. This process obviates the need to take a graft from another bone or bone donor. A.D.A.M. makes an emphasis on point-of-care cloud manufacturing to achieve scalability and streamline the interaction with surgeons, with an ultimate aim to substantially reduce costs for the orthopedic implants.
• In 2020, FDA confirmed 510(k) eligibility for A.D.A.M. biopolymer and bioceramic bone implants. No human trials are required. FDA clearance is expected in 2024.

21. Kolosis BIO | Salt Lake City, Utah, US | Founded: 2020

• In 2021, Kolosis BIO and MTF Biologics released Kore Fiber, an exclusively processed demineralized cortical fiber allograft for Kolosis. Kore is an aseptically-processed, 100% cortical bone matrix with ease of handling characteristics that is available in Moldable Fiber and Fiber Strip formats. Extensive pre-launch testing has shown Kore’s dynamic spectrum of growth factors that are essential for promoting and accelerating bone healing.
• Head-to-head testing has demonstrated that Kore Fiber has higher osteoinductivity than commercially available grafts from Medtronic, SeaSpine and Zimmer Biomet.
• Kolosis leadership brings experience from roles at Cook Medical, Lanx, Medtronic, NuVasive, Orthofix, Prosidyan, SI-BONE and Smith+Nephew.

22. GreenBone Ortho | Faenza, Ravenna, Italy | Founded: 2014

• Raised a total of €21.4 million (~US $22.4 million) in funding over three rounds, including venture and Series B.
• Developer of b.Bone, bone substitutes that mirror the structure of natural bone. b.Bone is obtained from rattan wood by a process, which preserves the wood’s 3D structure. The product is available in cylinder, wedge, block and granule formats and was approved under the CE Mark in 2019.

GreenBone’s b.Bone is obtained from rattan wood by a process, which preserves the wood’s 3D structure.

23. Hy2Care | Enschede, Netherlands | Founded: 2014

• Raised a total of €3.7 million (~US $3.8 million) in funding to date over two rounds, including seed and Series A.
• Hy2Care’s injectable hydrogel patch was developed for functional repair of cartilage defects in knee joints. Based on joint tissue-mimicking natural polymers, it aims to protect the injured site and facilitate natural repair.
• Hy2Care is a spin-off of the University of Twente. Product prototyping and first animal testing have been completed. A separate product and venture for veterinary applications is under development.
• Company leadership brings experience from roles at DSM Biomedical and DSM Dyneema.

24. Ossifix Technologies | Bee Cave, Texas, US | Founded: 2018

• Acquired by Umbra Companies in 2020.
• Ossifix engineers and manufactures 100% allograft bone implants for small bone/extremities (trauma) and sports medicine markets that also have application in craniofacial, spine and oral surgery procedures.
• Products are designed to be used in hospitals, ambulatory surgical centers and specialty clinics.
• Implants are fully absorbed by the patient’s body and replaced by the patient’s own bone. Each kit contains all instrumentation, bits and fixtures required for the implant placement, with components laid out in the order they are required during the procedure.

25. Sparta Biopharma | Madison, New Jersey, US | Founded: 2017

• In 2021 launched BioEnthesis, an allograft that possesses both mineralized and demineralized layers intended to support healing and repair within the rotator cuff.
• BioEnthesis biphasic cancellous bone allograft has an intact porous collagenous matrix for soft tissue ingrowth, and a highly calcified layer to promote osseointegration. It serves as a scaffold to repair the bone of the enthesis and provides a foundation to facilitate tendon incorporation.
• The company plans to focus on alternatives to knee replacements, biological options for rotator cuff surgery and a natural alternative to delay a hip replacement.
• Sparta Biomedical was also granted FDA’s Breakthrough Device Designation for the SBM-01 Biomimetic Implant. SBM-01 is intended to replace damaged knee cartilage in patients having single or multiple chondral or osteochondral defects in the knee.

This is by no means an exhaustive list of companies that deserve mention. We cover the journeys of many startups dedicated to novel technologies and new approaches throughout the year. Which companies would you like us to add to the list? Save Supplier