# K212782: SternaLock Sternal Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: May 17, 2022 after 258 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: 12 generations back to K761228 (1976). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161896: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2016) Summary page 5.

## Indications for use
The Biomet Microfixation SternaLock® 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, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.

Source page: https://510kreport.com/device/K212782
Methodology: https://510kreport.com/methodology