Cleared Traditional

K972501 - APOLLO REVISION/CONSTRAINED KNEE SYSTEM

K972501 is an FDA 510(k) clearance for APOLLO REVISION/CONSTRAINED KNEE SYSTEM, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972501 · Sulzer Orthopedics, Inc. · Orthopedic device
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Oct 1997
Decision
90d
Days
Class 2
Risk

K972501 is an FDA 510(k) clearance for the APOLLO REVISION/CONSTRAINED KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 1, 1997 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 Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K972501

510(k) Number K972501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date October 01, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K972501.
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
K972864 · Howmedica Corp. · Oct 1997
DURACON CONVERSION METAL BACKED PATELLA
K972752 · Howmedica Corp. · Oct 1997
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770 · Wrightmedicaltechnologyinc · Oct 1997
ADVANCE KNEE SYSTEM
K972626 · Wrightmedicaltechnologyinc · Sep 1997
APOLLO KNEE FEMORAL SPACERS
K971770 · Sulzer Orthopedics, Inc. · Jul 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · Implex Corp. · Jul 1997