Rigidfix Biocryl Cross Pin Kits
by Depuy Mitek, A Johnson & Johnson Company
510(k) K090669
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK090669 | Date3 Apr 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MAI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Rigidfix Biocryl Cross Pin Kits are biodegradable soft tissue fasteners used for graft fixation during orthopedic procedures. These devices are designed to provide secure fixation and facilitate a bone-to-graft interface.
The kits are supplied by Depuy Mitek and have received FDA 510(k) clearance. Available configurations include the 2.7mm BTB, 3.3mm Femoral ST, and 3.3mm Tibial ST models.
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Questions
AI-generated answers, 21 Sep 2026
What are the Rigidfix Biocryl Cross Pin Kits used for?
These devices are used as biodegradable soft tissue fasteners during orthopedic procedures. Their primary function is to provide secure graft fixation and facilitate a stable bone-to-graft interface.
What configurations are available for these kits?
The kits are available in three specific models to accommodate different surgical needs: the 2.7mm BTB, the 3.3mm Femoral ST, and the 3.3mm Tibial ST.
What is the regulatory status of these devices?
The Rigidfix Biocryl Cross Pin Kits have received FDA 510(k) clearance, which indicates that the device was found to be substantially equivalent to a legally marketed predicate device.