# K070928: Ceramic  Ball Heads, 28, 32 and 36 MM

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics AG
- Decided: Aug 1, 2007 after 120 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: 1 generation back to K061564 (2006). 1 ancestor in all.
18 later devices descend from it; 2 cite 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)
- K061564: Portland Ceramic (Biolox-Forte) Femoral Head, Portland Orthopaedics Pty., Ltd. (2006) Summary page 1.

## Most influential descendants
- 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
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own

## Indications for use
The Plus Orthopedics' Ceramic Ball Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for primary and revision total hip arthroplasty where the hip joint needs restructuring due to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Please note that the patient should be skeletally mature and the patient's condition should be due to the following: 1. Osteoarthritis 2. Rheumatoid arthritis 3. Tumor conditions involving the upper third of the femur of the Acetabular 4. Ankylosing spondylitis 5. Psoriatic arthritis 6. Old osteomyelitis - 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 osteotomy, Girdlestone resection, cup arthroplasty or hemi-arthroplasty. These ceramic ball heads are to be used only hip stems manufactured by Plus Orthopedics AG, specifically SL-PLUS®/SLR- PLUS®, SL- PLUS® Lateral, Modular- PLUS® and IPM stem.

Source page: https://510kreport.com/device/K070928
Methodology: https://510kreport.com/methodology