Copy to clipboard 
DePuy Synthes, long a player in the trauma and sports medicine segments, is joined by four startups that are building their portfolios in these fields. Three of the companies featured here are entering the market with their first orthopedic FDA 510(k) clearances.
Trauma
DePuy Synthes (submitted under CrossRoads Extremity Systems) | TriLEAP Lower Extremity Anatomic Plating, K230591
Submitted March 2023, granted September 2023
Primary predicate: Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System, K100776
FYI: Intended for the reduction, temporary fixation, fusion and stabilization of bones. The system includes 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure-specific plates, cortical screws and variable angle locking screws available in various sizes.
U.S. launch is slated for 2024.
Intelivation Technologies | Hammerdesis Interphalangeal Fusion, K231147
Submitted April 2023, granted September 2023
Primary predicate: Arthrex DynaNite PIP (Hammertoe) Implant, K190287
FYI: Hammerdesis allows surgeons to correct hammertoe deformities and degenerative issues by affixing a distinctively designed implant on the patient’s toe joint. It provides the potential for significant savings in intraoperative time and cost of care in the ambulatory surgery setting.
The system comprises a counter-rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg-and-hole fusion of the phalanges. The implant comes in two different sizes to accommodate various anatomies. The counter-rotation ring has axial spikes that prevent either side of the joint from rotating during fusion.
Voom Medical Devices | Revcon Screw System, K223392
Submitted November 2022, granted February 2023
Primary predicate: Wright Medical MICA Screw, K162353
FYI: This is Voom Medical’s first orthopedic FDA 510(k) clearance.
The Revcon Minimally Invasive Screw System exclusively offers the No-Fusion Bunion Solution and features the Revcon Anchor line, which the company describes as the only single-screw minimally invasive bunion surgery solution.
Market launch of the Revcon Anchor and full commercial launch of the company’s Bunionplasty procedure occurred in October. Bunionplasty employs proprietary methods that are now enhanced by the Revcon Anchor v2.0, in addition to the original Revcon Neutra v1.0 screws. Revcon Neutra v1.0 and Revcon Anchor v2.0 feature a neutral, non-compressive screw pitch that is engineered to stabilize bone segments and support bony healing and regeneration.
Founded in 2017, Voom Medical is headquartered in New York. The company is surgeon-founded and led by team members whose experience includes roles at MiRus, OsteoMed, Skeletal Dynamics, Small Bone Innovations, Smith+Nephew and Toby Orthopaedics.
Sports Medicine
Legends Orthopedics (submitted under Jarmon Medical) | Suture Anchors
Submitted February 2023, granted September 2023
Primary predicate: RoG Sports Medicine Suture Anchor, K111590
FYI: Clearance pertains to Legends Orthopedics’ 5.5mm Suture Anchor, 2.9mm Suture Anchor and 5.5mm Knotless Suture Anchor. The anchors are the first orthopedic FDA 510(k) clearance for Legends Orthopedics.
U.S. sales will commence by April 2024.
Simparo Surgical | Anchor Line Fixation System, K222574
Submitted August 2022, granted February 2023
Primary predicate: Arthrex CMC Mini TightRope, K140328
FYI: The Anchor Fixation System, Simparo’s first orthopedic FDA 510(k) clearance, is intended for use as a distribution bridge or for distributing suture tension over areas of ligament or tendon repair when used for bone-to-bone or soft tissue-to-bone fixation.
Anchor Line’s Falcon Suture Clutch Technology (a proprietary cinching and tensioning device) allows surgeons to perform CMC Suspensionplasty in fewer steps and with secure fixation and hassle-free suture management.
Falcon Suture Clutch is a tethering and tensioning system that adjusts for the line and angle of pull, allowing surgeons to apply tension comfortably and easily to the suspension sling and lock the tension in place intraoperatively. The procedure is performed through a single incision and doesn’t require bone tunnels or tendon harvesting.
Founded in 2013 and based in Mobile, Alabama, Simparo is led by an orthopedic industry veteran who has worked at Hand Innovations, Nexa Orthopedics, Nextremity Solutions, OsteoMed, Signal Medical, Smith & Nephew, Toby Orthopaedics, Tornier, Wright Medical and Z-KAT.
