# K082754: Aequalis Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Jan 27, 2009 after 130 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951740 (1995). 7 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042396: T2 Proximal Humeral Nail, Howmedica Osteonics Corp. (2004) Summary page 1.
- K042332: Titanium Telegraph Humeral Nail, Fournitures Hospitalieres Industrie (2004) Summary page 1.
- K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K103002: Synthes Multiloc Proximal Humeral Nailing System (2011), 17 descendants of its own
- K120807: Synthes Multiloc Humeral Nailing System (2012), 15 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K133376: Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right (2013), 3 descendants of its own

## Recalls of this device
- Mar 26, 2018 · Class II · Z-1757-2018: Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
- Jun 25, 2015 · Class II · Z-2315-2015: Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation wi

## Indications for use
The Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Source page: https://510kreport.com/device/K082754
Methodology: https://510kreport.com/methodology