# K011076: Lorenz Sternal Closure System with Modular Screw

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Jul 16, 2001 after 98 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
No predicates in its family tree.
110 later devices descend from it; 9 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own

Source page: https://510kreport.com/device/K011076
Methodology: https://510kreport.com/methodology