Cleared Traditional

KINAMED REALITY TOTAL HIP SYSTEM (K922247) - FDA 510(k) Clearance

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

K922247 · Kinamed, Inc. · Orthopedic device
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Mar 1994
Decision
686d
Days
Class 2
Risk

K922247 is an FDA 510(k) clearance for the KINAMED REALITY 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. (Newbury Park, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 686 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Kinamed, Inc. devices

Submission Details

510(k) Number K922247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date March 30, 1994
Days to Decision 686 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
564d slower than avg
Panel avg: 122d · This submission: 686d
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 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K922247.
SOLUTION HIP
K941942 · Depuy, Inc. · Jul 1994
STABILITY HIP STEM WITH POROCOAT
K934457 · Depuy, Inc. · Jul 1994
EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT
K931617 · Exactech, Inc. · Jun 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · Biomet, Inc. · Mar 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · Depuy, Inc. · Mar 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · Osteonics Corp. · Mar 1994