# K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Corporation
- Decided: Nov 1, 2016 after 215 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: 10 generations back to K810258 (1981). 127 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 6.
- K120578: Accolade II Hip Stem, Howmedica Osteonics (2012) Summary page 6.
- K883460: Focus Total Hip System, Depuy, Inc. (1988) Summary page 6.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 6.
- K060031: Depuy Modular M Heads, DePuy Orthopaedics, Inc. (2006) Summary page 6.
- K093235: Ringloc + Hybrid Acetabular System, Biomet, Inc. (2010) Summary page 6.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 6.
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 6.
- K072963: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2008) Summary page 6.
- K102423: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2010) Summary page 6.
- K112115: Mectacer Biolox (R) Delta Femoral Heads, Medacta International (2011) Summary page 6.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 6.
- K991026: Reflection Crosslinked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (1999) Summary page 6.
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 6.
- K013658: Modification to Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2001) Summary page 6.
- K931665: 6.5 MM Cancellous Bone Screw, Encore Orthopedics, Inc. (1994) Summary page 6.
- K033716: Trident Acetabular System, Howmedica Osteonics Corp. (2005) Summary page 6.
- K993352: Crossfire System 12 Acetabular Inserts, Howmedica Osteonics Corp. (1999) Summary page 6.
- K934060: Howmedica (R) Acetabular Comp Pack/Manuf Meth Change, Howmedica Corp. (1995) Summary page 6.

## Most influential descendants
- K242045: Initia T3 Acetabular Hemispherical Shell System (2025), 0 descendants of its own
- K243444: Bioceram Azul® Head (2024), 0 descendants of its own

## Indications for use
The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis, - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure, - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results, The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation. The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis, - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure, - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Source page: https://510kreport.com/device/K160895
Methodology: https://510kreport.com/methodology