Cleared Traditional

OSTEONICS SERIES 7000 AD TIBIAL TRAY (K983657) - FDA 510(k) Clearance

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

K983657 · Osteonics Corp. · Orthopedic device
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Apr 2000
Decision
535d
Days
Class 2
Risk

K983657 is an FDA 510(k) clearance for the OSTEONICS SERIES 7000 AD TIBIAL TRAY. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 6, 2000 after a review of 535 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Osteonics Corp. devices

Submission Details

510(k) Number K983657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date April 06, 2000
Days to Decision 535 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
413d slower than avg
Panel avg: 122d · This submission: 535d
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 K983657.
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · Biomet, Inc. · Jun 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810 · DePuy Orthopaedics, Inc. · Apr 2001
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K001451 · DePuy Orthopaedics, Inc. · May 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172 · DePuy Orthopaedics, Inc. · Feb 2000
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · Biomet, Inc. · May 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434 · Osteonics Corp. · Jan 1998