# K051590: T2 Ankle Arthrodesis Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 29, 2005 after 44 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 8 (0 Class I)
- 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; 10 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 no predicate by number.

## Most influential descendants
- K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System (2020), 11 descendants of its own
- K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) (2012), 11 descendants of its own
- K130147: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail) (2013), 9 descendants of its own
- K120419: Dyna Locking Ankle Nail (2012), 9 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own

## Recalls of this device
- Jun 27, 2018 · Class II · Z-2884-2018: Incomplete seal on the Tyvek lid may compromise the sterility of the device
- Dec 29, 2009 · Not classified · Z-0841-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Dec 29, 2009 · Not classified · Z-0842-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Dec 29, 2009 · Not classified · Z-0846-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Dec 29, 2009 · Not classified · Z-0843-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Dec 29, 2009 · Not classified · Z-0844-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Dec 29, 2009 · Not classified · Z-0845-2010: Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
- Nov 17, 2006 · Not classified · Z-1818-2009: Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).

## Indications for use
The T2" Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: Post-traumatic or primary Arthrosis Previously infected arthrosis (second degree) Revision of Failed Ankle Arthrodesis Failed Total Ankle Replacement Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot Ostheoartritis Nonunions or Pseudarthrosis of hindfoot and distal tibia Malunited tibial pilon fracture Charcot foot Severe endstage degenerative arthritis Severe defects after tumor resection Pantalar arthrodesis

Source page: https://510kreport.com/device/K051590
Methodology: https://510kreport.com/methodology