# K061882: Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Aug 1, 2006 after 29 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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) Apollo® Knee System: named in the summary without a submission number
- (no number) APR® Hip System: named in the summary without a submission number
- (no number) Bipolar Prosthesis: named in the summary without a submission number
- (no number) Epsilon™ Acetabular System: named in the summary without a submission number
- (no number) MOST® System: named in the summary without a submission number
- (no number) Natural-Knee® System: named in the summary without a submission number
- (no number) Natural-Knee® II System: named in the summary without a submission number

## Indications for use
Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed.

Source page: https://510kreport.com/device/K061882
Methodology: https://510kreport.com/methodology