# K193050: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Dec 26, 2019 after 55 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
Longest line of descent: 4 generations back to K871453 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962101: Zweymueller SL Femoral Hip Stem, Intermedics Orthopedics (1996) Summary page 4.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 4.
- K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 4.

## Most influential descendants
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants of its own

## Indications for use
Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems: • Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. • Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty

Source page: https://510kreport.com/device/K193050
Methodology: https://510kreport.com/methodology