Cleared Traditional

K160895 - Initia Total Hip System & BIOCERAM AZUL...

K160895 is an FDA 510(k) clearance for Initia Total Hip System & BIOCERAM AZUL..., manufactured by Kyocera Medical Corporation. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K160895 · Kyocera Medical Corporation · Orthopedic device
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Nov 2016
Decision
215d
Days
Class 2
Risk

K160895 is an FDA 510(k) clearance for the Initia Total Hip System & BIOCERAM AZUL(R) HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Kyocera Medical Corporation (Yodogawa-Ku, JP). The FDA issued a Cleared decision on November 1, 2016 after a review of 215 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Kyocera Medical Corporation devices

FDA 510(k) Submission Details - K160895

510(k) Number K160895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date November 01, 2016
Days to Decision 215 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 122d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 477
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K160895.
AMIStem-H Proximal Coating
K161635 · Medacta International S.A. · Mar 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
K161840 · Waldemar Link GmbH & Co. KG · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017
Zimmer M/L Taper Hip Prosthesis
K161830 · Zimmer, Inc. · Oct 2016
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Corin Optimized Positioning System (OPS)
K152893 · Corin USA · Jun 2016