# K091041: Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Aug 7, 2009 after 116 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971358 (1997). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090669: Rigidfix Biocryl Cross Pin Kits, Depuy Mitek, A Johnson & Johnson Company (2009) Summary page 1.
- K032167: Bio-Intrafix Tibial Screw and Sheath, Mitek Worldwide (2003) Summary page 1.
- K013572: Mitek Biocryl Interference Screws, Mitek Products (2002) Summary page 1.

## Most influential descendants
- K130105: Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System (2013), 0 descendants of its own

## Indications for use
RigidFix Biocryl Cross Pin Kits The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended femoral and/or tibial fixation of autograft or allograft ACL Bone-tendon-bone grafts. The RigidFix Biocryl Femoral 3.3 mm ST Cross Pin Kit is intended for femoral fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis). The RigidFix Biocryl Tibial 3.3 mm ST Cross Pin Kit is intended for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracillis). Biolntrafix Tibial Tapered Sheaths and Screws The Biolntrafix Tibial Screw and Tibial Sheath are intended for fixation of soft tissue grafts during cruciate ligament reconstruction. Biocryl Interference Screws The Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K091041
Methodology: https://510kreport.com/methodology