# K970912: Leibinger Self-Drilling Screw

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Oct 1, 1997 after 203 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: 2 generations back to K761228 (1976). 11 ancestors in all.
143 later devices descend from it; 4 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994) Summary page 1.
- K963739: Leibinger - Luhr Small Orthopedic Bone Screws, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K963740: Leibinger - Luhr Small Mandibular Bone Screws, Howmedica Leibinger, Inc. (1996) Summary page 1.
- K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws, Howmedica Leibinger, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K063506: Lorenz Sternal Closure System (2006), 87 descendants of its own

## Indications for use
This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

Source page: https://510kreport.com/device/K970912
Methodology: https://510kreport.com/methodology