Cleared Traditional

K944321 - S-ROM NOILES POSTERIOR STABILIZED TOTAL...

K944321 is an FDA 510(k) clearance for S-ROM NOILES POSTERIOR STABILIZED TOTAL..., 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 346-day FDA review.

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

FDA 510(k) Submission Details - K944321

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
Combination Product No
PCCP Authorized No
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.

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 K944321.
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · Howmedica Corp. · Sep 1995
GENESIS CONSTRAINED SYSTEM (GCS)
K952271 · Smith & Nephew Richards, Inc. · Sep 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · Smith & Nephew Richards, Inc. · Aug 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
K951956 · Osteonics Corp. · Aug 1995
DURACON BASEPLATES
K936008 · Howmedica Corp. · Aug 1995
GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM
K946088 · Smith & Nephew Richards, Inc. · Aug 1995