Cleared Traditional

ARIZONA CONDYLAR TIBIAL PLATEAU (K862125) - FDA 510(k) Clearance

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

K862125 · Depuy, Inc. · Orthopedic device
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Jun 1986
Decision
24d
Days
Class 2
Risk

K862125 is an FDA 510(k) clearance for the ARIZONA CONDYLAR TIBIAL PLATEAU. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Depuy, Inc. devices

Submission Details

510(k) Number K862125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date June 27, 1986
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 50
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K862125.
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · Osteonics Corp. · Jun 1991
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · Biomet, Inc. · Jan 1988
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · Depuy, Inc. · Mar 1986
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367 · Howmedica Corp. · Aug 1984
UNICONDYLAR FIBER METAL KNEE
K834298 · Zimmer, Inc. · Feb 1984