FDA Recap: Clearances Across Orthopedic Market Segments

In considering FDA 510(k)s from this year, we look at five from across the orthopedic market. I found these to be of interest, as they are granted to primarily lesser-known companies.

Joint Replacement

Onkos Surgical

ELEOS Limb Salvage System With BioGrip, K203815; submitted December 2020, granted June 2021

• Primary predicate: Onkos Surgical ELEOS Limb Salvage System with BioGrip, K203090
• About the product: Modular collar portfolio featuring BioGrip 3D-printed porous implant structure, created to help address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage. The BioGrip collar is designed to help provide bone ingrowth at the bone/implant interface, accelerating and enhancing osseointegration. The clearance also includes an oval shaped collar design to provide greater contact in distal femoral replacements, where subsidence is a common challenge among complex revision and trauma applications.
• About the company: Formed in 2015, based in Parsippany, New Jersey, beginning with a specialized focus on sarcoma, cancer that develops in bone and connective soft tissue. From 2015 through 2020, Onkos has raised $25.2 million in funding over three rounds. Leadership brings experience from Biomet, DJO Global, Stryker.

Spine

Medynus

Goblin and Goblin LS Pedicle Screw Systems, K210420; submitted February 2021, granted April 2021

• Predicate device: Globus Medical REVERE Stabilization System, K061202 and and K093294
• About the product: Titanium alloy top-loading multiple component, posterior spinal fixation systems comprising pedicle screws, rods, set screws, connectors and transverse linking mechanisms; company’s first FDA 510(k) clearance
• About the company: Established in 2019, headquartered in Irvine, California. Portfolio includes endoscopic spinal technology, 3D-printed solid and expandable cages, a percutaneous system and a demineralized bone matrix. Leadership team has experience from Aegis Spine, Corentec, GS Medical, Johnson & Johnson, Smith+Nephew, Synthes.

Trauma

Adaptable Ortho Innovations

Intramedullary Nail, K210285; submitted February 2021, granted March 2021

• Primary predicate: Zimmer Biomet M/DN Intramedullary Fixation System, K142281
• About the product: Adjustable length intramedullary nail, locking screws, and end caps, intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and postisthmic fractures; and tibial malunions and non-unions
• About the company: Formed in 2016, based in Potsdam, New York. The Adjustable Length Orthopedic Device, developed by a team at the Orthopaedic Biomechanics Laboratory at Clarkson University, is intended to bring better treatment to patients by ensuring that the correct size nail is always in stock. In 2018, Adaptable Ortho earned second place recognition in the inaugural Orthopaedic Research Society Business Plan Competition.

Via Surgical/Arthrex TissueTak

Sports Medicine

Via Surgical

TissueTak Tendon Anchor, K203117; submitted October 2020, granted January 2021

• Primary predicate: Via Surgical FasTouch Absorbable Fixation System, K181668
• About the product: Cleared under the General & Plastic Surgery panel; reportedly the first suture-based fixation system to be used for arthroscopic rotator cuff repair and augmentation. The suture-based anchor attaches the patch directly to the patient’s tendon, providing a strong alternative to traditional surgical staples or suture techniques which are inefficient and difficult to place. Multiple fasteners are deployed using an ergonomically-shaped device that inserts each faster to affix a biological patch to the patient’s own tissue without reloading or removing the device from the joint. TissueTak is a trademark owned by Arthrex.
• About the company: Founded in 2012, headquartered in Amirim, Israel, to develop fixation for hernia repair.

Interventional Systems Micromate

Robotics/Digital

Interventional Systems/ISYS Medizintechnik

Micromate Robotic Positioning Unit, K203720; submitted December 2020, granted June 2021

• Primary predicate: iSYS Medizintechnik, K131433
• About the product: Cleared under the Radiological panel. Reportedly the world’s smallest robot for percutaneous procedures. Previously operating in the U.S. spine fusion landscape through its partner company, Fusion Robotics, Micromate can perform almost every non-invasive image-guided procedure; table-mounted medical robot with a universal instrument guidance solution allows physicians to continue using their preferred surgical instruments. Targeting is performed under live-imaging using any Cone-Beam CT, Fluoro CT or a Fluoroscope.
• About the company: Founded in 2010, based in Kitzbuhel, Austria. Plans to launch U.S. operations in 2H21 by launching centers of excellence for robotic-guided interventional procedures and establishing commercial partnerships with third-parties that seek a robotic offering to their customers. Multiple members of leadership team have concurrent or past experience at Fusion Robotics.

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