# K151307: ICONACY (TM) I-Hip (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Iconacy Orthopedic Implants, LLC
- Decided: Feb 26, 2016 after 284 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 K850055 (1985). 105 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 4.
- K121034: Ioi Total Hip, Iconacy Orthopedic Implants, LLC (2012) Summary page 4.
- K131279: Iconacy I-Hip System, Iconacy Orthopedic Implants, LLC (2013) Summary page 4.
- K133228: Iconacy I-Hip System, Gradual Transitioning (GT) Femoral System, Iconacy Orthopedic Implants, LLC (2014) Summary page 4.
- K132572: I-Hip Total Hip System, Iconacy Orthopedic Implants, LLC (2014) Summary page 4.

## Most influential descendants
- K190704: Signature Ceramic Femoral Head (2019), 2 descendants of its own
- K181171: Zimmer Biomet Ceramic Heads (2019), 2 descendants of its own
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own

## Indications for use
The ICONACY I-Hip 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, 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-Hip 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/K151307
Methodology: https://510kreport.com/methodology