# K871347: Wagner Revisional Femoral Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Protek, Inc.
- Decided: Jul 1, 1987 after 86 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K994184: PLR Splined Revision Stem (2000), 0 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0213-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

Source page: https://510kreport.com/device/K871347
Methodology: https://510kreport.com/methodology