# K063506: Lorenz Sternal Closure System

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Dec 18, 2006 after 28 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
Longest line of descent: 7 generations back to K761228 (1976). 20 ancestors in all.
87 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001). Our reading of the summary gave K001076, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lorenz Sternal Closure System”. Summary page 1.
- K033740: Lorenz Sternal Closure System, Walter Lorenz Surgical, Inc. (2003) Summary page 1.
- K013954: Lorenz Self Drilling Screws, Walter Lorenz Surgical, Inc. (2002) Summary page 1.
- K032228: Lorenz 2.4 Self Drilling Screws, Walter Lorenz Surgical, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K122293: Pioneer Sternal Cable Plate System (2012), 46 descendants of its own
- K133785: Tritium Sternal Cable Plate System (2014), 45 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/K063506
Methodology: https://510kreport.com/methodology