# K960988: Lactosorb Trauma Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Poly-Medics,Inc.
- Decided: Apr 10, 1996 after 34 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.
95 later devices descend from it; 5 cite it directly.
0 of 96 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
- K974554: Synthes Resorbable Fixation System (1998), 89 descendants of its own
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 descendants of its own
- K972913: Macropore Protective Sheet (Protego System) (1998), 84 descendants of its own
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own

## Indications for use
The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. 1. Comminuted fractures of the naso-ethmoidal and infraorbital areas. 2. Comminuted fractures of the frontal sinus wall. 3. Trauma of the midface or craniofacial skeleton. 4. Reconstructive procedures of the midface or craniofacial skeleton. This system is not designed for use in the mandible and/or full load bearing procedures.

Source page: https://510kreport.com/device/K960988
Methodology: https://510kreport.com/methodology