# K110574: Biomet Microfixation Sternalock Blu Sternal Closure System

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation, Inc.
- Decided: May 18, 2011 after 78 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K761228 (1976). 21 ancestors in all.
84 later devices descend from it; 8 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Cited in the summary but kept off the family tree
- K010746: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K111908: Biomet Microfixation Sternal Closure System (2011), 78 descendants of its own
- K121302: Biomet Microfixation Sternal Closure System (2012), 75 descendants of its own
- K122293: Pioneer Sternal Cable Plate System (2012), 46 descendants of its own
- K133785: Tritium Sternal Cable Plate System (2014), 45 descendants of its own
- K150581: Tritium Sternal Cable Plate System (2015), 44 descendants of its own

## Recalls of this device
- Nov 23, 2011 · Not classified · Z-0843-2012: Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw 

## Indications for use
Biomet Microfixation SternaLock Blu 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/K110574
Methodology: https://510kreport.com/methodology