Cleared Traditional

S-ROM NOILES CRUCIATE RETAINING KNEE (K936037) - FDA 510(k) Clearance

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

K936037 · Joint Medical Products Corp. · Orthopedic device
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Oct 1994
Decision
287d
Days
Class 2
Risk

K936037 is an FDA 510(k) clearance for the S-ROM NOILES CRUCIATE RETAINING 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 October 3, 1994 after a review of 287 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 Joint Medical Products Corp. devices

Submission Details

510(k) Number K936037 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 20, 1993
Decision Date October 03, 1994
Days to Decision 287 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 122d · This submission: 287d
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 K936037.
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
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EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
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ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT
K936079 · Exactech, Inc. · Sep 1994
ORTHOLOC ADVANTIM
K933290 · Wrightmedicaltechnologyinc · Sep 1994
ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE
K934620 · Wrightmedicaltechnologyinc · Sep 1994