Cleared Traditional

KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL (K912295) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912295 · Kinamed, Inc. · Orthopedic device
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Aug 1991
Decision
82d
Days
Class 2
Risk

K912295 is an FDA 510(k) clearance for the KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL. 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. (Washington, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kinamed, Inc. devices

Submission Details

510(k) Number K912295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1991
Decision Date August 12, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 122d · This submission: 82d
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 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K912295.
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · Biomet, Inc. · Jan 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · Exactech, Inc. · Jan 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · Zimmer, Inc. · Jan 1992
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · Biomet, Inc. · Apr 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · Zimmer, Inc. · Mar 1991
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · Osteonics Corp. · Aug 1990