# K963739: Leibinger - Luhr Small Orthopedic Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Jan 22, 1997 after 127 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K761228 (1976). 7 ancestors in all.
144 later devices descend from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K761228: Luhr Mandibular Compression-Screw System, Howmedica Corp. (1976) Summary page 1.
- K882454: Luhr Micro System, Howmedica Corp. (1988) Summary page 1.
- K913355: Luhr Pan Fixation System, Howmedica Corp. (1991) Summary page 1.
- K935448: Luhr Mini Bone Screw and Z Plate, Howmedica Corp. (1994) Summary page 1.
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K862482: Steinhauser Titanium Mini Bone Plates & Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K961485: Forefoot Reconstruction System, Howmedica Corp. (1996) Summary page 1.

## Most influential descendants
- 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
- K032228: Lorenz 2.4 Self Drilling Screws (2003), 101 descendants of its own
- K033740: Lorenz Sternal Closure System (2003), 100 descendants of its own

## Indications for use
It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction.

Source page: https://510kreport.com/device/K963739
Methodology: https://510kreport.com/methodology