# K021351: Biosteon Cross Pin

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Oct 17, 2002 after 171 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003641 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011172: Arthrex Bio-Transfix, Arthrex, Inc. (2001)
- K003641: Biolok Screw, Biosteon Screw, Biocomposites, Ltd. (2001) Summary page 1.

## Most influential descendants
- K033792: Bilok ST Screw (2004), 0 descendants of its own

## Recalls of this device
- Aug 23, 2005 · Not classified · Z-0165-06: The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surg

## Indications for use
The Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

Source page: https://510kreport.com/device/K021351
Methodology: https://510kreport.com/methodology