# K955944: Osteonics N2/Vac Packaging Process

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 9, 1996 after 133 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934060 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934060: Howmedica (R) Acetabular Comp Pack/Manuf Meth Change, Howmedica Corp. (1995) Summary page 1.
- K936292: Packaging and Manufacturing Methods Change/Knee Components, Howmedica Corp. (1995) Summary page 1.
- K940743: Uhmwpe Components-Change in Packaging, Depuy, Inc. (1995) Summary page 1.

## Indications for use
The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.

Source page: https://510kreport.com/device/K955944
Methodology: https://510kreport.com/methodology