# K042396: T2 Proximal Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 8, 2004 after 36 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K082754: Aequalis Humeral Nail System (2009), 22 descendants of its own
- K103002: Synthes Multiloc Proximal Humeral Nailing System (2011), 17 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K120807: Synthes Multiloc Humeral Nailing System (2012), 15 descendants of its own

## Recalls of this device
- Nov 7, 2013 · Class II · Z-0849-2014: Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for certain lots of the product Teflon Tube, st

## Indications for use
The T2 Proximal Humeral Nail 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.

Source page: https://510kreport.com/device/K042396
Methodology: https://510kreport.com/methodology