# K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Dec 17, 2003 after 26 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871453 (1987). 4 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.

## Most influential descendants
- K133832: Klassic HD Hip System, Offset Femoral Stem, Non-Porous / Porous (2014), 2 descendants of its own
- K131454: Klassic HD (TM) Extended Offset Femoral Head (2014), 2 descendants of its own
- K193050: Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem (2019), 1 descendant of its own
- K151440: Klassic HD Hip System (2015), 1 descendant of its own
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0214-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 

## Indications for use
The Alloclassic SL Offset Femoral Stem is intended for prosthetic replacement without bone cement in treatment of the following: * patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. * those patients with failed previous surgery where pain, deformity, or dysfunction persists. * revision of a previously failed hip arthroplasty. * patients who require a total hip replacement.

Source page: https://510kreport.com/device/K033664
Methodology: https://510kreport.com/methodology