# K973837: CLS Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, SL

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Jan 6, 1998 after 90 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) APR System: named in the summary without a submission number
- (no number) Natural Hip System: named in the summary without a submission number

## Most influential descendants
- K183141: LINK MP Monoblock Hip Prosthesis (2019), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own

## Indications for use
The CLS, Wagner Revision and AlloClassic Zweymuller femoral stems will be used in conjunction with the Zirconia Ceramic Total Head. This stem/head combination is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty in which the ball head articulates with a polyethylene acetabular component. Specific diagnostic indications include: Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis); Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and, Revision of previously failed hip arthroplasty. The CLS Stem, Wagner Revision Stem and AlloClassic Zweymuller Stem are intended for use with or without bone cement.

Source page: https://510kreport.com/device/K973837
Methodology: https://510kreport.com/methodology