# K992063: Osteo IC Femoral and Tibial Nails in Titanium Alloy

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 3, 1999 after 77 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.
13 later devices descend from it; 1 cites it directly.
0 of 14 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) Osteo IC Femoral and Tibial Nails in Stainless Steel: named in the summary without a submission number
- (no number) Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy: named in the summary without a submission number

## Most influential descendants
- K011622: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2 Locking Screws (2001), 12 descendants of its own
- 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

## Indications for use
The indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows: Closed and open femoral and tibial shaft fractures Pseudarthrosis and correction osteotomies in the shaft area Pathological fractures and tumor resections of the shaft area Change of procedure following external fixation.

Source page: https://510kreport.com/device/K992063
Methodology: https://510kreport.com/methodology