# K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical
- Decided: Sep 6, 2011 after 102 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: 7 generations back to K930712 (1993). 79 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 84 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.
- K960339: Consensus 22MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960156: Consensus 32MM Cocrmo Femoral Head, U.S. Medical Products, Inc. (1996) Summary page 2.
- K960340: Consensus Apex Dome Hole Plug, U.S. Medical Products, Inc. (1996) Summary page 2.
- K102399: Consensus Taperset Hip System, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K100933: Consensus CS2 Plus Acetabular Insert, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K020153: Consensus Acetablar Shell, TI Coated, Hayes Medical, Inc. (2002) Summary page 2.

## Most influential descendants
- K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert (2012), 1 descendant of its own
- K191826: KeYi Total Hip System (2020), 0 descendants of its own
- K150576: TGM Biolox delta Ceramic Heads (2015), 0 descendants of its own
- K121509: Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert (2012), 0 descendants of its own

## Indications for use
The HELICONTM Hip System is designed for total hip arthroplasty. 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, pseudarthrosis conversion, and structural abnormalities The HELICONTM hip stem is indicated for cementless use. The HELICONTM acetabular shell component is indicated for cemented or cementless use.

Source page: https://510kreport.com/device/K111472
Methodology: https://510kreport.com/methodology