# K991763: Lactosorb Hand System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 30, 1999 after 67 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K023887: Inion Otps Biodegradable Mini Plating System (2003), 4 descendants of its own
- K063410: Inion CPS/Otps Freedomplate (2007), 2 descendants of its own
- K081588: RE-Zorb Plating System (2008), 1 descendant of its own
- K120163: Acute Innovations Biobridge Resorbable Plating System (2012), 0 descendants of its own
- K050388: Refix Internal Fracture Fixation Screws (2005), 0 descendants of its own

## Indications for use
The LactoSorb® Hand System is indicated for surgical fixation of closed non-comminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.

Source page: https://510kreport.com/device/K991763
Methodology: https://510kreport.com/methodology