# K213580: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

- Pathway: 510(k) (Special)
- Applicant: Total Joint Othopedics, Inc.
- Decided: Dec 3, 2021 after 23 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.
1 later device descends from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K243809: Biolox® Delta Revision heads (2025), 0 descendants of its own

## 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 (IJD): 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/K213580
Methodology: https://510kreport.com/methodology