Cleared Traditional

K890472 - ATH CERAMIC UHMWPE TOTAL HIP SYSTEM

K890472 is the FDA 510(k) clearance for ATH CERAMIC UHMWPE TOTAL HIP SYSTEM by Kinamed, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K890472 · Kinamed, Inc. · Orthopedic device
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Sep 1989
Decision
214d
Days
Class 2
Risk

K890472 is an FDA 510(k) clearance for the ATH CERAMIC UHMWPE TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Kinamed, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 1, 1989 after a review of 214 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 Kinamed, Inc. devices

Submission Details

510(k) Number K890472 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 30, 1989
Decision Date September 01, 1989
Days to Decision 214 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 122d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K890472.
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · Osteonics Corp. · Oct 1989
CERAMIC FEMORAL HEAD
K893685 · Dow Corning Wright · Sep 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · Richards Medical Co., Inc. · Sep 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · Osteonics Corp. · Jun 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082 · Depuy, Inc. · Jun 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
K891083 · Depuy, Inc. · Jun 1989