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Startups breathe new life into the orthopedic market and introduce innovations that push past the assumed limitations of surgical care. Here are a few of the early-stage companies we’ll be watching as they continue to advance solutions that help surgeons restore the natural function and movement of knees, hips and vertebrae.
OrthoPreserve
In January, the company secured FDA Breakthrough Device designation and Total Product Lifecycle Advisory Program (TAP) Enrollment for Defender, a meniscus implant that restores knee function for patients who continue to experience pain or impairment after meniscus surgery.
Current meniscus surgeries can relieve pain in the short term, but some patients experience poor outcomes over the long term and may develop degenerative arthritis that leads to a knee replacement. Defender is designed to restore the natural stabilization and cushioning functions of the meniscus, offering a less invasive alternative to the current standard of care: a partial meniscectomy, which removes damaged tissue but often leads to joint deterioration.
OrthoPreserve plans to launch its pilot clinical trial in 2026, with the goal of securing FDA clearance by 2029. Notably, orthopedic devices were not included in the TAP program before January 2025, making Defender one of the first to achieve this distinction.
CytexOrtho
CytexOrtho’s ReNew Hip Implant won the inaugural OrthoPitch Technology Competition at the AAOS 2024 Annual Meeting, an event that recognized innovations with the potential to redefine orthopedic care.
ReNew Hip is designed to restore natural hip function rather than replace diseased portions of the joint with an artificial implant. It’s made of a 3D-woven textile and a Tru3D-printed structure, a combination that replicates the form and function of healthy articular cartilage and bone.
Unlike traditional joint replacement implants, ReNew Hip is bioabsorbable, so it gradually integrates with the body while supporting the regeneration of functional cartilage and bone. Over time, cells populate the implant’s porous structure, forming new tissue as the implant resorbs.
ReNew Hip received FDA Breakthrough Device designation in early 2023, and FDA has approved the implant for the first-in-human Phase I clinical trial, which will assess its safety and efficacy in up to 15 patients (ages 14 to 55) with hip disease resulting in the loss of articular cartilage integrity on the femoral head.
Askel Healthcare
Knee osteoarthritis cases are increasing significantly worldwide, largely due to untreated cartilage damage, and Askel Healthcare wants to address the issue with a first-line surgical solution for cartilage defects.
The company’s COPLA device is a biodegradable implant that’s engineered for ease of implantation and unrestricted full weight-bearing post-surgery. Last June, the company presented the results of the device’s first-in-human pilot clinical trial, which showed its potential as a first-line treatment option for knee cartilage repair.
The trial’s first 10 subjects did not suffer implant-related complications, achieved unrestricted weight-bearing immediately after surgery and through six months’ follow-up, and experienced significant improvement in knee function and pain relief. Additionally, the patients achieved normal knee movement and strength within three months of surgery and reported high satisfaction rates with the procedure.
Askel Healthcare noted that the pilot trial showed COPLA improved post-op rehabs for patients and led to a quicker return to normal life activities for patients. The company also said early mechanical loading enhances cartilage regeneration, which contributes to the formation of high-quality tissue needed for improved long-term outcomes. It’s targeting FDA clearance in 2030.
Foundation Surgical
This early-stage startup’s Vertiwedge intraosseous device is a first-of-its-kind implant designed to maintain motion preservation in the spine. Vertiwedge is engineered to mimic the natural topology of cancellous bone, enhancing biomechanical compatibility, osseointegration and load distribution.
In November 2024, the company secured FDA 510(k) clearance for the Class II motion preservation and motion-sparing device.
Foundation Surgical leveraged advanced additive manufacturing to produce Vertiwedge in hundreds of configurations, allowing surgeons to tailor treatment options based on the specific anatomical needs of individual patients. The device is implanted during vertebral body osteotomy, a motion preservation surgery that’s an alternative to traditional spinal fusion. Surgeons use the Vertiwedge to perform a partial vertebral body replacement, preserving motion while addressing pain and spinal deformity.
Vertiwedge’s mechanical structure mimics natural spinal kinematics, allowing the spine to maintain flexibility and movement. The device can reduce the risk of long-term complications associated with fusion, such as adjacent segment disease, while enhancing the quality of life for patients.
In October 2024, Foundation Surgical also secured FDA 510(k) clearance to market its Interwedge Standalone Lateral Interbody System, the first bilateral-fixated standalone-lateral procedure performed through a single-position lateral or oblique-lateral lumbar spine approach.
Allumin8
The company introduced Therapeutic Hardware, a first-of-its-kind spine platform technology that features a porous design aimed at promoting healing, reducing reoperation rates and improving patient outcomes. The technology’s porous structures are designed to enhance bone integration, draw bone marrow stem cells into the implant to promote healing and infection resistance and strengthen fusion sites.
Traditional spine implants focus solely on mechanical fixation without addressing the biological factors that promote healing. ALLUMIN8’s 3D-printed Therapeutic Hardware is designed to diagnose, treat and heal through the devices.
The company’s Cultiv8 lattice structure focuses on bone adhesion and accelerated osseointegration, addressing critical failure points in traditional spine surgery hardware. The integrated Circul8 adapter was designed to enable the delivery of stem cells, drugs and personalized therapeutics directly to the surgical site, providing options for patients who need more than biomechanical stability.
The company’s INTEGR8 porous pedicle screw system features proximal thread topography for stability in the pedicle and facilitates the injection of biologics. It can draw stem cells internally and is designed to harvest bone and cells during insertion.
The company is awaiting FDA 510(k) clearance for its pedicle screw.
VISIE
The company’s Continuous Anatomic Auto Tracking (CAAT) technology provides advanced vision capabilities during robotic-assisted total knee replacements. VISIE’s expertise in high-speed 3D scanning allows for the continuous tracking of the joint’s movement in real time.
Proprietary digital scanners capture hundreds of thousands of data points within a fraction of a second. These data points are quickly registered to a CT scan, allowing the VISIE’s 3D scanners to track the femur or tibia as they move during surgery. Integrated robotic arms can then move in sync with the knee and seamless tracking of the joint’s motion occurs without the use of traditional fixation pins.
The ability to track anatomy in real time without pin fixation could represent a significant step forward in robotic-assisted surgery in several orthopedic applications. It also has the potential to improve surgical outcomes in knee replacement surgery by offering more precise joint alignment and reducing the need for manual adjustments during surgery.
VISIE is validating CAAT’s performance with the goal of submitting the technology for FDA evaluation.
