# K971870: Lactosorb Trauma Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 19, 1997 after 90 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.
96 later devices descend from it; 11 cite it directly.
0 of 97 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
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 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
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own

## Indications for use
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: 1. Comminuted fractures of the naso-ethmoidal infraorbital areas 2. Comminuted fractures of the frontal sinus wall 3. Pediatric midface or craniofacial trauma 4. Lefort (I,II,III) fractures 5. Orbital floor fractures 6. Fractures of the maxilla, Zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones 7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications: 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.) Lefort (I,IX,III) osteotomies Tumor reconstruction in midface or craniofacial procedures Bone graft procedures in the midface or craniofacial skeleton Pediatric reconstructive procedures Reconstructive procedures of the craniofacial skeleton including: frontal. parieta temporal, sphemoid, and occipital bones 7. Craniotom fixation

Source page: https://510kreport.com/device/K971870
Methodology: https://510kreport.com/methodology