Copy to clipboard 
I continually discover new players in the market while combing through listings of FDA 510(k) clearances. The companies featured below recently received their first orthopedic-related clearances for products in the sports medicine segment. Sironix has continued to notch clearances for additional sports med devices with its product portfolio.
CC-Instruments | CC-Clip Implant
CC-Instruments | CC (coracoclavicular)-Clip Implant System, K232780
Submitted September 2023, granted December 2023
Primary predicate: Arthrex TightRope Acromioclavicular Device, K052776
FYI: This implant is intended as an adjunct in coracoclavicular ligament disruption repair.
Specifically, the CC-Clip provides fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Important features include:
- The clavicular clip loop that hides the interconnecting suture knot into the clavicular drill hole, eliminating protruding knots.
- The 5.0mm outer diameter that fits snugly into the 5.5mm-6.0 mm clavicular drill hole. It squeezes the tendon graft against the drill hole walls, eliminating the use of an interference screw.
- The width (8.0 mm) and length (16.0-20.0 mm) of the clavicular clip provide a snowshoe effect to prevent the implant from sinking into the bone.
- The dorsal rim of the clip that reduces pressure induced by the tendon graft sling onto the clavicular bone to eliminate bone resorption.
Juha O. Ranne M.D., Ph.D., inventor of the technique and the CC-Clip, is based in Finland. CC-Instruments is based in Dover, Delaware.
CelestRay Biotech | SpinMedix Absorbable Fibrous Membrane, K222220
Submitted July 2022, granted July 2023
Primary predicate: MAST Biosurgery Surgi-Wrap MAST Tendon Sheet, K063648
FYI: Indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. This implantable synthetic membrane, made of biodegradable polymers, wraps around a ruptured tendon during its repair. The membrane helps prevent the scarring of the tendon that could impede its ability to slide naturally.
CelestRay’s SpinMedix implant was developed in China. CelestRay Biotech, a Maryland-based startup, was guided through the 510(k) clearance with assistance from the Robert E. Fischell Institute for Biomedical Devices.
OTS Medical | OTS 25 All-Suture Anchor, K233429
Submitted October 2023, granted December 2023
Primary predicate: CONMED Y-Knot All-Suture Anchor, K133224
FYI: This non-absorbable suture anchor is intended to reattach soft tissue to bone during arthroscopic or open surgical procedures. After the suture strands are anchored to bone, both may be used to reattach soft tissue such as ligaments, tendons or joint capsules. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.
OTS Medical is based in Israel. Leadership brings experience from roles at OEMs such as OrthoSpace and Stryker and suppliers such as Integer, Nordson Medical and Vention Medical.
Sironix (Healthium Medtech) | STATIV Knotted UHMWPE Suture Anchor
Sironix (Healthium Medtech) | STATIV Knotted UHMWPE Suture Anchor, K223889
Submitted December 2022, granted March 2023
Primary predicate: Arthrex FiberTak Suture Anchor, K203268
FYI: STATIV is indicated for the fixation of soft tissue to bone in a range of surgical procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip.
STATIV is available in a self-tap/self-punching variant.
Sironix and parent company Healthium Medtech, preparer of the submission, are based in India. Since this initial product, Healthium has been granted clearance to market the Ceptre Knotted UHMWPE Suture PEEK Anchor, Surestitch UHMWPE Suture PEEK Button for Meniscus Repair, T-Button A Adjustable Loop UHMWPE Suture PEEK Button and T-Button S Adjustable Loop UHMWPE Suture PEEK Button. Healthium’s arthroscopy solutions include a range of 300+ implants and equipment that are designed to help treat soft tissue conditions in the shoulders and knees. The entire portfolio has been designed and developed in-house under the brand name Sironix.
