# K130105: Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 17, 2013 after 122 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971358 (1997). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974341: Mitek BTB Absorbable (Pla) Cross Pin, Mitek Products (1998) Summary page 1.
- K090669: Rigidfix Biocryl Cross Pin Kits, Depuy Mitek, A Johnson & Johnson Company (2009) Summary page 1.
- K091041: Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin Kits, Depuy Mitek, A Johnson & Johnson Company (2009) Summary page 1.
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord, Depuy Mitek, A Johnson & Johnson Company (2011) Summary page 1.

## Indications for use
The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.

Source page: https://510kreport.com/device/K130105
Methodology: https://510kreport.com/methodology