# K993956: Titanium Pediatric Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 20, 1999 after 28 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 11 (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). 1 ancestor in all.
14 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 2.
- (no number) Biomet/OEC Stainless Steel Flexible Nails: named in the summary without a submission number

## Most influential descendants
- K111232: Gap Endo-Exo Medullary System (2012), 7 descendants of its own
- K160545: Gap Endo-Exo Medullary System (2016), 6 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
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2311-2009: 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-2307-2009: 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-2312-2009: 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-2308-2009: 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-2306-2009: 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-2310-2009: 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-2305-2009: 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-2303-2009: 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-2302-2009: 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-2309-2009: 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-2304-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

## Indications for use
The Titanium Pediatric Femoral Nail is indicated for fractures of the femur including: non-comminuted and comminuted mid-shaft fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures.

Source page: https://510kreport.com/device/K993956
Methodology: https://510kreport.com/methodology