# K972637: Precedent Revision Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Oct 1, 1997 after 78 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 1 cites it directly.
0 of 26 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) Sentry Femoral Component: named in the summary without a submission number
- (no number) S-ROM® Femoral Prosthesis: named in the summary without a submission number
- (no number) Stability Hip Stem: named in the summary without a submission number
- (no number) Wagner Revision Stem: named in the summary without a submission number

## Most influential descendants
- K032380: Wagner Cone Prosthesis (2003), 24 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K113556: Wagner Cone Prosthesis System (2012), 9 descendants of its own
- K161192: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System (2016), 8 descendants of its own
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own

## Indications for use
The general indications associated with the use of the Precedent Revision Hip system without HA in total hip arthroplasty include: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (ID), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed arthroplasty. The Precedent Revision Hip System without HA is intended only for use without bone cement.

Source page: https://510kreport.com/device/K972637
Methodology: https://510kreport.com/methodology