# K010839: CLS Varus Stem/CLS 135 Stem

- Pathway: 510(k) (Special)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Apr 18, 2001 after 28 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103431: Coren Total Hip System (2011), 11 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
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own

Source page: https://510kreport.com/device/K010839
Methodology: https://510kreport.com/methodology