Cleared Traditional

K944321 - S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II (FDA 510(k) Clearance)

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

K944321 · Joint Medical Products Corp. · Orthopedic device
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Aug 1995
Decision
346d
Days
Class 2
Risk

K944321 is an FDA 510(k) clearance for the S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II. 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 August 14, 1995 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K944321 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 02, 1994
Decision Date August 14, 1995
Days to Decision 346 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 122d · This submission: 346d
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

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