# K990152: Osteo IC Retrograde/Antegrade Femoral Nail Nut and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 15, 1999 after 55 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Richards Retrograde Nail: named in the summary without a submission number

## Indications for use
The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are 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/K990152
Methodology: https://510kreport.com/methodology