# K191399: BIOLOX CONTOURA Ceramic Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Total Joint Othopedics, Inc.
- Decided: Aug 28, 2019 after 96 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: 12 generations back to K810258 (1981). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100445: Klassic HD Hip System, Total Joint Orthopedics, Inc. (2010) Summary page 5.
- K180929: Klassic HD® Hip System, Total Joint Orthopedics, Inc. (2018) Summary page 5.
- K143407: Klassic HD Hip System, Total Joint Othopedics, Inc. (2014) Summary page 5.

## Indications for use
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following: » Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia. » Patient conditions of inflammatory joint disease (1JD): rheumatoid arthritis. * Those patients with failed previous surgery where pain, deformity, or dysfunction persists. * Revision of a previously failed hip arthroplasty. » Patients who require a total hip replacement.

Source page: https://510kreport.com/device/K191399
Methodology: https://510kreport.com/methodology