# K100008: Cardo Medical Ceramic Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Cardo Medical, Inc.
- Decided: May 18, 2010 after 134 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: 6 generations back to K931641 (1994). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073068: Accin Hip System, Accelerated Innovation, LLC (2008) Summary page 1.
- K094045: Modificaiton to: Cardo Medical Hip System, Cardo Medical Corp. (2010). Cleared while this submission was under review Summary page 1.
- K033944: Stelkast 32MM Modular Ceramic Femoral Head, Stelkast Company (2004) Summary page 1.

## Indications for use
The Cardo Medical Hip System components are for use in total hip arthroplasty as a result of: * Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoiarthritis, and arthritis resulting from biologic or mechanical trauma to the hip * Correction of functional deformity * Avascular Necrosis * Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur * Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation with or without bone cement.

Source page: https://510kreport.com/device/K100008
Methodology: https://510kreport.com/methodology