# K984585: Osteonics +10 Unipolar Adaptor Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 24, 1999 after 62 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.
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) Howmedica Unitrax Unipolar Neck Adjustment Sleeve Component: named in the summary without a submission number
- (no number) Osteonics Neck Extension for Modular Endo Head: named in the summary without a submission number

## Indications for use
The indications for use of the Osteonics’ +10 UniPolar Adaptor 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. • Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: • Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum. • Salvage of failed total hip arthroplasty.

Source page: https://510kreport.com/device/K984585
Methodology: https://510kreport.com/methodology