# K111908: Biomet Microfixation Sternal Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation, Inc.
- Decided: Nov 29, 2011 after 147 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K761228 (1976). 26 ancestors in all.
78 later devices descend from it; 6 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011076: Lorenz Sternal Closure System with Modular Screw, Walter Lorenz Surgical, Inc. (2001) Summary page 2.
- K033740: Lorenz Sternal Closure System, Walter Lorenz Surgical, Inc. (2003) Summary page 2.
- K063506: Lorenz Sternal Closure System, Walter Lorenz Surgical, Inc. (2006) Summary page 2.
- K110574: Biomet Microfixation Sternalock Blu Sternal Closure System, Biomet Microfixation, Inc. (2011) Summary page 2.
- K093772: Synthes Sternal Fixation System, Synthes (2010) Summary page 2.
- K110789: Synthes Sternal Zipfix System, Synthes (Usa) (2011). Cleared while this submission was under review Summary page 2.
- K931271: Ethi-Pack* Surgical Stainless Steel Suture, ETHICON, Inc. (1994) Summary page 2.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 2.

## Most influential descendants
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K151019: SternaLock® 360 Sternal Closure System (2015), 43 descendants of its own
- K163007: Biomet Microfixation SternaLock 360 Sternal Closure System (2016), 40 descendants of its own
- K202889: Able Medical Devices Valkyrie Thoracic Fixation System (2021), 39 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 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 hone quality.

Source page: https://510kreport.com/device/K111908
Methodology: https://510kreport.com/methodology