# K990291: Lactosorb Bone Pin

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 23, 1999 after 53 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
4 later devices descend from it; 3 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 no predicate by number.

## Most influential descendants
- K043339: Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG (2005), 1 descendant of its own
- K151876: Bio2 Fusion Implant System (2015), 0 descendants of its own
- K140625: Orthosorb LS (2014), 0 descendants of its own
- K011451: Reunite Fusion Screw (2001), 0 descendants of its own

## Recalls of this device
- Jul 7, 2004 · Not classified · Z-0013-05: Mislabeled as to size; 1.55 mm pins are labeled as 2mm.

## Indications for use
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate immobilization in the following procedures: 1. correction of hallux valgus (bunion) 2. repair of metacarpal and phalangeal fusion and fractures

Source page: https://510kreport.com/device/K990291
Methodology: https://510kreport.com/methodology