Device Information
The AlphaVent Knotless SP PEEK Anchors are single-use bone anchors with a screw-in mechanism. They consist of a poly-ether-ether-ketone (PEEK) eyelet and anchor body, pre-assembled on a disposable stainless-steel inserter. This anchor comes in sizes 4.75mm, 5.5mm, and 6.5mm. The anchors can be inserted into the bone using self-punching or a pre-made pilot hole. They are sterile, packaged in sterile barrier systems, and sterilized via Ethylene Oxide to a Sterility Assurance Level of 10-6. These devices are designed for use in professional healthcare facilities.
Indications
The device is indicated for soft-tissue to bone fixation in shoulder, knee, ankle, wrist, hip, and elbow procedures in adults and skeletally mature pediatric patients. Specific procedures include rotator cuff repair, Achilles tendon repair, ACL repair, and more.
Intended Use
This device is intended for use in skeletally mature pediatric and adult patients requiring soft-tissue to bone fixation in various parts of the body. The device is designed for healthcare professionals in professional settings.
Availability
The AlphaVent Knotless SP PEEK Anchor is available by prescription only.
Study Results
- Non-Clinical and Safety Testing: Bench tests confirmed that the device meets or exceeds performance characteristics, including ultimate tensile strength and successful insertion. The device underwent biological risk assessment and bacterial endotoxin testing, meeting all relevant safety standards.
Regulatory Information
- Regulation Number: 21 CFR 888.3040
- Regulatory Class: Class II
- Product Code: MBI
- 510(k) Number: K233893
- Additional regulatory requirements include compliance with Quality System (QS) regulations like 21 CFR 820.30 for design controls.
Manufacturer Information
- Name: Stryker Endoscopy
- Address: 5900 Optical Court, San Jose, California 95138
- Contact Person: Madison Mutchler, Senior Regulatory Affairs Specialist
Predicate Device Information
- Primary Predicate Device: Arthrex SwiveLock Anchor (K203495)
- Reference Device: Stryker AlphaVent PEEK Suture Anchor (K231093)
- The AlphaVent Knotless SP PEEK Anchor shares the same intended use and technical characteristics as its predicate device, but it performs better in certain areas, such as ultimate tensile strength.
Implications
This device can provide reliable and efficient soft-tissue-to-bone fixation. Its substantial equivalence to predicate devices ensures that it is safe and effective for its intended use.
References
- AlphaVent Knotless SP PEEK Anchor. 510(k) Number: K233893. Stryker Endoscopy: FDA Summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233893
- https://www.stryker.com/us/en/sports-medicine/products/AlphaVent-hard-body-screw-in-anchor-platform.html
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