# K030373: Alloclassic Zweymueller SL/SLL Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Mar 6, 2003 after 30 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: 2 generations back to K871453 (1987). 3 ancestors in all.
278 later devices descend from it; 9 cite it directly.
0 of 282 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 2.

## Most influential descendants
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K070981: Search Evolution (LC) Total Knee System (Plasmapore) (2007), 79 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0210-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
The AlloclassicTMZweymuellerTM SUSLL 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 requires a total hip replacement.

Source page: https://510kreport.com/device/K030373
Methodology: https://510kreport.com/methodology