# K032380: Wagner Cone Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Sep 22, 2003 after 52 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: 5 generations back to K921308 (1994). 17 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955296: Link MP Reconstruction Hip, Link America, Inc. (1996) Summary page 1.
- K022549: Restoration Modular System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K960588: Wagner Revision Stem, Intermedics Orthopedics (1996) Summary page 1.
- K972637: Precedent Revision Hip System, Sulzer Orthopedics, Inc. (1997) Summary page 1.

## Most influential descendants
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 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
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own

## Indications for use
The Wagner Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are: 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 previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K032380
Methodology: https://510kreport.com/methodology