# K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical, Inc.
- Decided: Oct 24, 2012 after 142 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K930712 (1993). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 2.
- K935193: Consensus Hip System- Porous Coated Titianium Femoral Stem, U.S. Medical Products, Inc. (1994) Summary page 2.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 3.
- K070061: 36MM Cocr Femoral Head and 36MM Acetabular Insert, Hayes Medical, Inc. (2007) Summary page 2.
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head, Aesculap, Inc. (2006) Summary page 3.
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon, Tgm Medical (2011) Summary page 2.

## Most influential descendants
- K150576: TGM Biolox delta Ceramic Heads (2015), 0 descendants of its own

## Indications for use
The ZENITH Hip. System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System. The indications for use are: 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, osteomnalacia, osteoporosis, pseudlarthrosis conversion, and structural abnormalities. The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

Source page: https://510kreport.com/device/K121636
Methodology: https://510kreport.com/methodology