# K161896: Biomet Microfixation Sternal Closure System

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation
- Decided: Aug 2, 2016 after 22 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: 11 generations back to K761228 (1976). 28 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 4.

## Most influential descendants
- K232829: Versalock Rib and Sternum Plates System (2024), 0 descendants of its own
- K233967: DePuy Synthes MatrixSTERNUM Fixation System (2024), 0 descendants of its own
- K212782: SternaLock Sternal Closure System (2022), 0 descendants of its own
- K181806: ARIX Sternal System (2018), 0 descendants of its own

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

Source page: https://510kreport.com/device/K161896
Methodology: https://510kreport.com/methodology