# K982601: Osteo IC Retrograde/Antegrade Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 14, 1998 after 49 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.
56 later devices descend from it; 2 cite it directly.
0 of 57 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) Synthes Titanium Distal Femoral System: named in the summary without a submission number
- (no number) Synthes Titanium Unreamed Femoral Nail System: named in the summary without a submission number
- (no number) AIM Titanium Femoral Nail: named in the summary without a submission number
- (no number) Richards Retrograde Nail: named in the summary without a submission number

## 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
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own

## Indications for use
The Osteo IC Retrograde/Antegrade Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following: Open and closed femoral fractures. Pseudarthrosis and correction osteotomy. Pathologic fractures, impending pathologic fractures, and tumor resections. Supracondylar fractures, including those with intra-articular extension. Ipsilateral femur/tibia fractures. Fractures proximal to a total knee arthroplasty. Fractures distal to a hip implant. Nonunions and malunions.

Source page: https://510kreport.com/device/K982601
Methodology: https://510kreport.com/methodology