# K974309: Lactosorb Panels

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 30, 1998 after 74 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.
167 later devices descend from it; 7 cite it directly.
0 of 168 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 its predicate without a number.
- (no number) LactoSorb mesh in the LactoSorb Trauma Plating System: named in the summary without a submission number
- (no number) thin metal meshes: named in the summary without a submission 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
- K032698: Coapt Endotine Midface-ST 4.5 Device (2003), 74 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K041593: Featherlift Extended Length Aptos Thread (2004), 72 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 infraobital 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.) 2. tumor reconstruction in midface or craniofacial procedures 3. bone graft procedures in the midface or craniofacial skeleton 4. pediatric reconstructive procedures 5. reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones 6. craniotomy flap fixation

Source page: https://510kreport.com/device/K974309
Methodology: https://510kreport.com/methodology