Cleared Traditional

NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT (K972270) - FDA 510(k) Clearance

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

K972270 · Zimmer, Inc. · Orthopedic device
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Nov 1997
Decision
166d
Days
Class 2
Risk

K972270 is an FDA 510(k) clearance for the NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 24, 1997 after a review of 166 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 Zimmer, Inc. devices

Submission Details

510(k) Number K972270 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 11, 1997
Decision Date November 24, 1997
Days to Decision 166 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
44d slower than avg
Panel avg: 122d · This submission: 166d
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 K972270.
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT
K972967 · Osteonics Corp. · Jan 1998
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · Wrightmedicaltechnologyinc · Dec 1997
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
K973406 · Osteonics Corp. · Dec 1997
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
K973164 · Howmedica Corp. · Nov 1997
INTERAX TOTAL KNEE SYSTEM
K973121 · Howmedica Corp. · Nov 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K972863 · Howmedica Corp. · Oct 1997