# K033740: Lorenz Sternal Closure System

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Dec 15, 2003 after 17 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: 6 generations back to K761228 (1976). 19 ancestors in all.
100 later devices descend from it; 5 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032228: Lorenz 2.4 Self Drilling Screws, Walter Lorenz Surgical, Inc. (2003) Summary page 1.
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001)

## Most influential descendants
- 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
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K051165: KLS Martin Sternal Talon (2006), 62 descendants of its own

## Indications for use
Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.

Source page: https://510kreport.com/device/K033740
Methodology: https://510kreport.com/methodology