# K072161: Biomet Femoral Locking Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 20, 2007 after 45 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982953 (1998). 3 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983641: Holland Femoral Nail System, Biomet, Inc. (1998) Summary page 1.
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.
- K023267: T2 Supracondylar Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.

## Most influential descendants
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K083726: Pedinail Intramedullary Nailing System (2009), 6 descendants of its own
- K172583: OrthoPediatrics PediNail Intramedullary Platform (2018), 4 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2283-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2279-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2278-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2277-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2281-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2280-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2282-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Mar 27, 2009 · Not classified · Z-2115-2009: Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.

## Indications for use
These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis

Source page: https://510kreport.com/device/K072161
Methodology: https://510kreport.com/methodology