# K142484: Sternal Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Jace Medical, LLC
- Decided: Oct 31, 2014 after 57 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). 89 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 4.
- K111908: Biomet Microfixation Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 4.
- K121302: Biomet Microfixation Sternal Closure System, Biomet Microfixation (2012) Summary page 4.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 4.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 4.
- K051165: KLS Martin Sternal Talon, KLS-Martin L.P. (2006) Summary page 4.
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile, KLS Martin L.P. (2007) Summary page 4.

## Most influential descendants
- K210290: JACE Medical Thoracic Plating System (2021), 0 descendants of its own

## Indications for use
The Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Source page: https://510kreport.com/device/K142484
Methodology: https://510kreport.com/methodology