# K010801: T2 Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 6, 2001 after 21 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
No predicates in its family tree.
91 later devices descend from it; 12 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series (2005), 53 descendants of its own
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own
- K082770: Zimmer Natural Nail System Tibial Nail (2008), 35 descendants of its own
- K101438: T2 Greater Trochanter Nail (2010), 25 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own

## Recalls of this device
- Jun 30, 2016 · Class II · Z-2792-2016: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
- Oct 4, 2005 · Not classified · Z-0169-06: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shippi

Source page: https://510kreport.com/device/K010801
Methodology: https://510kreport.com/methodology