# K992570: Unitrax C-Taper Neck Adjustment Sleeve

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 1, 1999 after 30 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 2 cite it directly.
0 of 76 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) Unitrax® V40™ Neck Adjustment Sleeve: named in the summary without a submission number

## Most influential descendants
- K063791: Corin Unipolar Modular Head (2007), 63 descendants of its own
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own

## Indications for use
The indications for use of the Unitrax® C-Taper Neck Adjustment Sleeve, in keeping with those of the legally marketed predicate devices, are as follows: For Use as a Hemi-Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head/neck Osteo- and post traumatic arthritis

Source page: https://510kreport.com/device/K992570
Methodology: https://510kreport.com/methodology