Cleared Traditional

ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE (K945087) - FDA 510(k) Clearance

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

K945087 · Wrightmedicaltechnologyinc · Orthopedic device
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Mar 1995
Decision
151d
Days
Class 2
Risk

K945087 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE. 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 March 17, 1995 after a review of 151 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K945087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date March 17, 1995
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 K945087.
DURACON RECESSED PATELLA
K951655 · Howmedica Corp. · Jul 1995
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
K950010 · Johnson & Johnson Professionals, Inc. · May 1995
DURACON STABILIZER FEMORAL COMPONENT AND INSERT
K932070 · Howmedica Corp. · Mar 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · Exactech, Inc. · Mar 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · Exactech, Inc. · Feb 1995
NEXT GENERATION KNEE SYSTEM
K933785 · Zimmer, Inc. · Jan 1995