Cleared Traditional

DURACON PS LIPPED TIBIAL INSERT (K012172) - FDA 510(k) Clearance

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

K012172 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
90d
Days
Class 2
Risk

K012172 is an FDA 510(k) clearance for the DURACON PS LIPPED TIBIAL INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics (Allendale, US). The FDA issued a Cleared decision on October 10, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Howmedica Osteonics devices

Submission Details

510(k) Number K012172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date October 10, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K012172.
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
K012778 · Smith & Nephew, Inc. · Mar 2002
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K013991 · Zimmer, Inc. · Dec 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · Howmedica Osteonics Corp. · Nov 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · Biomet, Inc. · Aug 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · Exactech, Inc. · Jul 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · Exactech, Inc. · Jul 2001