# K042249: CLS Spotorno Stem

- Pathway: 510(k) (Special)
- Applicant: Zimmer Austin, Inc.
- Decided: Sep 15, 2004 after 27 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
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 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) CLS Stems: named in the summary without a submission number

## Most influential descendants
- K103431: Coren Total Hip System (2011), 11 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
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K120924: Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw Hole Plug (2012), 8 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0234-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
The CLSTM Spotorno TM Femoral Stem is intended for cementless use in total hip replacement in treatment of the following: * patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative joint disease (IJD), e.g- rheumatoid arthritis; * those patients with failed previous surgery where pain, deformity, or dysfunction persists; * revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K042249
Methodology: https://510kreport.com/methodology