Cleared Traditional

K945087 - ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE

K945087 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K945087 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K945087

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.

JWH Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K945087.
NATURAL-KNEE II SYSTEM
K936159 · Intermedics Orthopedics · May 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
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
K934381 · Intermedics Orthopedics · Feb 1995