# K032523: T2 Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 22, 2003 after 68 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 3 cite it directly.
0 of 34 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 its predicate without a number.
- (no number) Polarus Proximal Humeral Nail (Acumed, Inc.): named in the summary without a submission number
- (no number) Zimmer’s M/DN Humeral Nail: named in the summary without a submission number
- (no number) Polarus Plus Humeral Nail (Acumed, Inc.): named in the summary without a submission number
- (no number) previously cleared T2 Humeral Nail System by Howmedica Osteonics Corp.: named in the summary without a submission number

## Most influential descendants
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own
- K102597: Piccolo Composite Plate System (2011), 15 descendants of its own
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own

## Indications for use
T2 Proximal Humeral Nail The T2 Proximal Humeral Nail is intended to be used for various types of proximal and/or diaphyseal fractures of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The T2 Proximal Humeral Nail is intended for single use only. Examples of specific indications according to A 0 classification include Type A-Fractures, dislocated, Type BFractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification. T2 Humeral Nail The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be static, dynamic and compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but not limited to fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

Source page: https://510kreport.com/device/K032523
Methodology: https://510kreport.com/methodology