# K992355: Lactosorb Trauma Plating System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 20, 1999 after 159 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.
14 later devices descend from it; 6 cite it directly.
0 of 15 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
- K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059 (2005), 3 descendants of its own
- K033918: Ebi Lactosorb Graft Containment System (2004), 3 descendants of its own
- K112064: Resorb X-G (2012), 2 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K073115: Orthomesh (2008), 1 descendant of its own

## Indications for use
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: Comminuted fractures of the naso-ethmoidal infraorbital areas Comminuted fractures of the frontal sinus wall Pediatric midface or craniofacial trauma LeFort (LILIII) fractures Orbital floor fractures Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones 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: Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.) LeFort (LILIII) 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, parietal, temporal, sphenoid, and occipital bones Craniotomy flap fixation

Source page: https://510kreport.com/device/K992355
Methodology: https://510kreport.com/methodology