Cleared Traditional

ORTHOLOC ADVANTIM (K933290) - FDA 510(k) Clearance

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

K933290 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 1994
Decision
422d
Days
Class 2
Risk

K933290 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 1, 1994 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K933290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date September 01, 1994
Days to Decision 422 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 122d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K933290.
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726 · Exactech, Inc. · Oct 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235 · Wrightmedicaltechnologyinc · Oct 1994
ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE
K934620 · Wrightmedicaltechnologyinc · Sep 1994
THICK TIBIAL INSERT
K933289 · Wrightmedicaltechnologyinc · Aug 1994
HOWMEDICAL TOTAL KNEE STEM EXTENDER
K924482 · Howmedica Corp. · Feb 1994