# K111936: Ortho Devlopment Ceramic Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Ortho Development
- Decided: Sep 21, 2011 after 75 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: 8 generations back to K810258 (1981). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053587: Ortho Development Ceramic Femoral Heads with Pres-Fit Stems, Ortho Development Corp. (2006) Summary page 1.
- K060577: Ortho Development Ceramic Femoral Heads, Ortho Development Corp. (2006) Summary page 1.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 1.

## Indications for use
The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem). Total hip arthroplasty is indicated for the following conditions: 1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis. 2. Previously failed hip surgery. 3. Fractures of the femoral neck or head. 4. Avascular necrosis of the femoral head. 5. Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Source page: https://510kreport.com/device/K111936
Methodology: https://510kreport.com/methodology