Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221468 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a biodegradable fastener for soft tissue fixation, comprising the Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants. It is intended for fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist.
The device is supplied sterile and is single-use. It is classified as a Class II medical device under FDA regulation number 888.3030 and has received 510(k) clearance (K221468) as substantially equivalent to a predicate device. The device is used in orthopedic procedures and is manufactured by Acuitive Technologies, Inc.
Frequently asked questions
What is the Citregen Tendon Interference Screw used for?
The device is intended for fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist, providing biodegradable soft tissue fixation during orthopedic procedures.
How is the Citregen Tendon Interference Screw supplied and is it reusable?
The device is supplied sterile and is designated for single-use only, meaning it must be discarded after one procedure to maintain sterility and prevent cross-contamination.
What regulatory pathway was used for the Citregen Tendon Interference Screw?
The device received 510(k) clearance (K221468) as substantially equivalent to a predicate device and is classified as a Class II medical device under FDA regulation number 888.3030.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Citrelock - Stryker, Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation ..., PDF Robert itregen™ itrespline™ itrelock™, Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221468 | Class II | Active |
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Manufacturer
- Manufacturer
- Acuitive Technologies, Inc.
Sources (1)
- FDA 510(k) K221468 24 fields · synced Sep 22, 2026