# K011622: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 15, 2001 after 21 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
Longest line of descent: 1 generation back to K982601 (1998). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992063: Osteo IC Femoral and Tibial Nails in Titanium Alloy, Howmedica Osteonics Corp. (1999) Summary page 1.
- K982601: Osteo IC Retrograde/Antegrade Femoral Nail, Osteonics Corp. (1998) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 1.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw (2014), 2 descendants of its own
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own

## Indications for use
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications. Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063): Open and closed femoral and tibial shaft fractures Pseudoarthrosis and correction osteotomies Pathologic fractures and tumor resections Change of procedure following external fixation Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601): The Osteo R/A Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following: Open and closed femoral fractures Pseudoarthrosis and correction osteotomy Pathologic fractures, impending pathologic fractures, and tumor resections Supracondylar fractures, including those with intra-articular extension Ipsilateral femur fractures Fractures proximal to a total knee arthroplasty Fractures distal to a hip implant Nonunions and malunions

Source page: https://510kreport.com/device/K011622
Methodology: https://510kreport.com/methodology