# K961485: Forefoot Reconstruction System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 1, 1996 after 44 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.
190 later devices descend from it; 3 cite it directly.
0 of 191 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) Luhr® Fixation System: named in the summary without a submission number
- (no number) Alta® Modular Trauma Small Bone Plating System: named in the summary without a submission number
- (no number) Synthes® Small Fragment and Mini Set: named in the summary without a submission number

## Most influential descendants
- K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws (1997), 188 descendants of its own
- K963739: Leibinger - Luhr Small Orthopedic Bone Screws (1997), 144 descendants of its own
- K970912: Leibinger Self-Drilling Screw (1997), 143 descendants of its own
- K974785: Auto-Drive Bone Screw (1998), 141 descendants of its own
- K013954: Lorenz Self Drilling Screws (2002), 117 descendants of its own

## Indications for use
The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface.

Source page: https://510kreport.com/device/K961485
Methodology: https://510kreport.com/methodology