# K992158: Lactosorb Sheets

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 20, 1999 after 56 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
87 later devices descend from it; 4 cite it directly.
0 of 88 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
- 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
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own

## Indications for use
The LactoSorb® Sheets are used as fixation devices in the following procedures: 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. Orbital floor fractures 5. 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.) 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 6. Craniotomy flap fixation C. Mandible Indication: Used to maintain the position of bony fragments in mandibular bone graft procedures and are used in conjunction with rigid internal fixation.

Source page: https://510kreport.com/device/K992158
Methodology: https://510kreport.com/methodology