# K021254: Lactosorb Mini Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jul 17, 2002 after 89 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
Longest line of descent: 1 generation back to K954443 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954443: Lactosorb Suture Anchor, Poly-Medics,Inc. (1996) Summary page 1.

## Indications for use
The LactoSorbB Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization.

Source page: https://510kreport.com/device/K021254
Methodology: https://510kreport.com/methodology