# K061564: Portland Ceramic (Biolox-Forte) Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Portland Orthopaedics Pty., Ltd.
- Decided: Sep 1, 2006 after 88 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
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ceramic femoral heads manufactured by DePuy: named in the summary without a submission number
- (no number) Ceramic femoral heads manufactured by Exactech: named in the summary without a submission number
- (no number) Ceramic femoral heads manufactured by Plus: named in the summary without a submission number

## Most influential descendants
- K070928: Ceramic  Ball Heads, 28, 32 and 36 MM (2007), 18 descendants of its own
- K073337: Mectacer Biolox Forte-Femoral Heads (2008), 16 descendants of its own
- K112115: Mectacer Biolox (R) Delta Femoral Heads (2011), 14 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own

## Indications for use
The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use: * The patient should be skeletally mature. * The patient's condition should be due to one or more of the following: 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Tumor conditions involving the upper third of the femur or of the Acetabular. 4. Ankylosing spondylitis. 5. Psoriatic arthritis. 6. Old osteomyclitis - with a long infection-free period and a normal WBC, ESR and C-reactive protein. 7. Non union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Source page: https://510kreport.com/device/K061564
Methodology: https://510kreport.com/methodology