# K051826: Betacone Hip Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Nov 18, 2005 after 136 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871453 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930963: SL-Plus & SLR-Plus Stems W/Biolox Ceramic Heads, Encore Orthopedics, Inc. (1994) Summary page 2.
- K042249: CLS Spotorno Stem, Zimmer Austin, Inc. (2004) Summary page 2.
- K010839: CLS Varus Stem/CLS 135 Stem, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- K033664: Modification to Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.
- K030373: Alloclassic Zweymueller SL/SLL Femoral Stem, Centerpulse Orthopedics, Inc. (2003) Summary page 2.

## Indications for use
The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following: • Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis; * Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and * Revision of a previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K051826
Methodology: https://510kreport.com/methodology