# K110039: Biomet Sports Medicine Sternal Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: May 3, 2011 after 117 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K761228 (1976). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 1.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- K930015: Sternal Band, Stony Brook Surgical Innovations, Inc. (1993) Summary page 1.
- K013059: Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures), Stony Brook Surgical Innovations, Inc. (2001) Summary page 1.
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K063506: Lorenz Sternal Closure System, Walter Lorenz Surgical, Inc. (2006) Summary page 1.

## Most influential descendants
- K191030: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer (2020), 0 descendants of its own

## Indications for use
The Biomet Sports Medicine 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/K110039
Methodology: https://510kreport.com/methodology