# K050118: Ebi Trochanteric Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Feb 16, 2005 after 29 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983641 (1998). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K120148: Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw (2012), 6 descendants of its own
- K202099: AOS Galileo™ Trochanteric Nail System (2020), 4 descendants of its own
- K133081: Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N (2013), 2 descendants of its own
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own
- K252025: Active Intramedullary (AIM) Tibial Nail System (2026), 0 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1819-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non
- Mar 30, 2012 · Not classified · Z-1478-2012: The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation
- Jun 24, 2005 · Not classified · Z-0012-06: Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

## Indications for use
The EBC® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotornies. reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.

Source page: https://510kreport.com/device/K050118
Methodology: https://510kreport.com/methodology