510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160895Substantially Equivalent

Initia Total Hip System & BIOCERAM AZUL(R) HEAD

KYOCERA Medical Corporation, Yodogawa-Ku, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160895 is the FDA 510(k) clearance record for Initia Total Hip System & BIOCERAM AZUL(R) HEAD, a class II device, cleared for Kyocera Medical Corporation on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list one 510(k) clearance for Kyocera Medical Corporation. As of , FDA records show no recalls naming K160895.

Clearance record

Decision date
Received
(215 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Kyocera Medical Corporation Uemura Nissei Bldg., 3-3-31 Miyahara, Yodogawa-Ku, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZO

Trailing 12 months
8 clearances under product code LZO in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20260