# K121034: Ioi Total Hip

- Pathway: 510(k) (Traditional)
- Applicant: Iconacy Orthopedic Implants, LLC
- Decided: Sep 4, 2012 after 152 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 K850055 (1985). 90 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005)
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.
- K110400: Taperloc Complete Microplasty Stem, Biomet Manufacturing Corp (2011)
- K070369: Regenerx Ringloc + Modular Acetabular Shells, Biomet, Inc. (2007) Summary page 1.
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K131279: Iconacy I-Hip System (2013), 8 descendants of its own
- K132572: I-Hip Total Hip System (2014), 7 descendants of its own
- K133228: Iconacy I-Hip System, Gradual Transitioning (GT) Femoral System (2014), 7 descendants of its own
- K151307: ICONACY (TM) I-Hip (TM) (2016), 6 descendants of its own
- K190704: Signature Ceramic Femoral Head (2019), 2 descendants of its own

## Indications for use
The ICONACY I-Hip system is indicated for the following conditions: 1. A severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, artlirodesis, hemniartliroplasty, surface replacement arthiroplasty, or total hip replacement. 5. Certain cases of ankylosis. 6. Nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The ICONACY i-Flip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation.

Source page: https://510kreport.com/device/K121034
Methodology: https://510kreport.com/methodology