# K982531: Howmedica Leibinger Resorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 16, 1998 after 88 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.
83 later devices descend from it; 4 cite it directly.
0 of 84 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 Trauma Plating System: named in the summary without a submission number
- (no number) Luhr® Pan Fixation System: named in the summary without a submission number

## Most influential descendants
- 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
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own

## Indications for use
The Howmedica Leibinger Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients, but is not intended for use in the mandible and/or full load bearing procedures.

Source page: https://510kreport.com/device/K982531
Methodology: https://510kreport.com/methodology