# K010633: Rigidfix Soft Tissue Acl Crosspin System

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: May 9, 2001 after 68 days
- Product code: HWC (Screw, Fixation, Bone)
- 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek 3.3mm ST Femoral RigidFix™ Crosspin System: named in the summary without a submission number
- (no number) Linvatec BioScrew® Absorbable Interference Screw: named in the summary without a submission number

## Most influential descendants
- K090669: Rigidfix Biocryl Cross Pin Kits (2009), 2 descendants of its own
- 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
- K063719: Arthrex Crosspin, Model AR-1964P (2007), 0 descendants of its own

## Indications for use
The RigidFix™ Tibial ACL CrossPin System is indicated for tibial fixation of autograft or allograft ACL soft tissue grafts (semitendinosus and gracilis).

Source page: https://510kreport.com/device/K010633
Methodology: https://510kreport.com/methodology