# K962101: Zweymueller SL Femoral Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Aug 19, 1996 after 81 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: 1 generation back to K871453 (1987). 2 ancestors in all.
283 later devices descend from it; 4 cite it directly.
0 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871453: Zweymueller-SL Hip Prosthesis Stem, Allo Pro Corp. (1987) Summary page 2.
- K930963: SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads, Encore Orthopedics, Inc. (1994) Summary page 3.

## Most influential descendants
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem (2003), 278 descendants of its own
- 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

## Indications for use
The Zweymueller SL Femoral Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the Zweymueller SL Femoral Hip Stem is intended to be intraoperatively assembled to the commercially available Sulzer Orthopedics Limited (SOL) or Intermedics Orthopedics, Inc. (IOI) femoral bearing heads. The general indications associated with the use of Zweymueller SL 2. Fracture or avascular necrosis. 3. Conditions consequent to earlier operations such as joint reconstruction (Osteotomy), arthrodesis, hemi-arthroplasty, or total hip replacement (THP), total knee replacement, as well as “operations on shoulder and elbow joints, and spinal surgery.

Source page: https://510kreport.com/device/K962101
Methodology: https://510kreport.com/methodology