Cleared Traditional

K896397 - S-ROM(TM)/NOILES(TM) MARK 5 KNEE

K896397 is an FDA 510(k) clearance for S-ROM(TM)/NOILES(TM) MARK 5 KNEE, manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K896397 · Joint Medical Products Corp. · Orthopedic device
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Feb 1990
Decision
107d
Days
Class 2
Risk

K896397 is an FDA 510(k) clearance for the S-ROM(TM)/NOILES(TM) MARK 5 KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 107 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 Joint Medical Products Corp. devices

FDA 510(k) Submission Details - K896397

510(k) Number K896397 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 07, 1989
Decision Date February 22, 1990
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 K896397.
KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM
K901338 · Kirschner Medical Corp. · May 1990
NUFFIELD TOTAL KNEE
K892503 · Orthopedic Systems, Inc. · May 1990
WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
K896081 · Dow Corning Wright · Mar 1990
ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))
K896542 · Techmedica, Inc. · Feb 1990
MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
K895639 · Zimmer, Inc. · Feb 1990
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
K894403 · Howmedica Corp. · Feb 1990