Cleared Traditional

K940235 - ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT

K940235 is an FDA 510(k) clearance for ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K940235 · Wrightmedicaltechnologyinc · Orthopedic device
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Oct 1994
Decision
260d
Days
Class 2
Risk

K940235 is an FDA 510(k) clearance for the ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT. 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 October 5, 1994 after a review of 260 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 - K940235

510(k) Number K940235 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 18, 1994
Decision Date October 05, 1994
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 K940235.
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334 · Orthomet, Inc. · Oct 1994
AXIOM TOTAL KNEE SYSTEM
K932677 · Orthomet, Inc. · Oct 1994
NUFFIELD TOTAL KNEE
K931960 · Turnkey Intergration USA, Inc. · Oct 1994
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037 · Joint Medical Products Corp. · Oct 1994
CONSENSUS KNEE SYSTEM - PRIMARY KNEE
K932837 · U.S. Medical Products, Inc. · Sep 1994
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210 · Dow Corning Wright · Sep 1994