# K090669: Rigidfix Biocryl Cross Pin Kits

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Apr 3, 2009 after 21 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: 5 generations back to K971358 (1997). 15 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K013781: Rididfix 2.7MM BTB Cross Pin Kit, Mitek Products (2002) Summary page 1.
- K010633: Rigidfix Soft Tissue Acl Crosspin System, Mitek Products (2001) Summary page 1.
- K974341: Mitek BTB Absorbable (Pla) Cross Pin, Mitek Products (1998) Summary page 1.
- K974291: Mitek BTB Absorbable (Pla) Cross Pin, Mitek Products (1998) 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
- K091041: Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits (2009), 1 descendant of its own
- 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
The RigidFix Biocryl 2.7 mm BTB Cross Pin Kit is intended for 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).

Source page: https://510kreport.com/device/K090669
Methodology: https://510kreport.com/methodology