# K955729: Lactosorb Trauma Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Poly-Medics,Inc.
- Decided: Feb 14, 1996 after 58 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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.
95 later devices descend from it; 6 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974554: Synthes Resorbable Fixation System (1998), 89 descendants of its own
- K972919: Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw (1998), 87 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

## Recalls of this device
- Mar 19, 2008 · Not classified · Z-1872-2008: The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and 

Source page: https://510kreport.com/device/K955729
Methodology: https://510kreport.com/methodology