# K013954: Lorenz Self Drilling Screws

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Feb 28, 2002 after 90 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: 4 generations back to K761228 (1976). 16 ancestors in all.
117 later devices descend from it; 6 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983485: Synthes 1.3 MM Self-Drilling Screw, Synthes (Usa) (1998) Summary page 1.
- K974785: Auto-Drive Bone Screw, Osteomed Corp. (1998) Summary page 1.
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 1.

## Most influential descendants
- 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
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System (2011), 84 descendants of its own
- K111908: Biomet Microfixation Sternal Closure System (2011), 78 descendants of its own

## Indications for use
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, fingers and toes, for the fixation of fractures, osteotomies, revision procedures, joint fusion and reconstructive procedures.

Source page: https://510kreport.com/device/K013954
Methodology: https://510kreport.com/methodology