# K150576: TGM Biolox delta Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical, Inc.
- Decided: Sep 9, 2015 after 187 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: 9 generations back to K930712 (1993). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131684: Biolox (R) Delta Ceramic Heads, Biomet, Inc. (2013) Summary page 4.
- K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 4.
- K040644: Modification to Depuy Ceramic Femoral Head, DePuy Orthopaedics, Inc. (2004) Summary page 4.
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon, Tgm Medical (2011) Summary page 4.
- K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert, Tgm Medical, Inc. (2012) Summary page 4.

## Indications for use
TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the femoral head. E. Non-union of proximal femoral neck fractures. F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

Source page: https://510kreport.com/device/K150576
Methodology: https://510kreport.com/methodology