Cleared Traditional

K941769 - KNEE PROTHESIS

K941769 is an FDA 510(k) clearance for KNEE PROTHESIS, 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 296-day FDA review.

K941769 · Joint Medical Products Corp. · Orthopedic device
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Feb 1995
Decision
296d
Days
Class 2
Risk

K941769 is an FDA 510(k) clearance for the KNEE PROTHESIS. 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 1, 1995 after a review of 296 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

FDA 510(k) Submission Details - K941769

510(k) Number K941769 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 11, 1994
Decision Date February 01, 1995
Days to Decision 296 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
174d slower than avg
Panel avg: 122d · This submission: 296d
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 K941769.
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
K934381 · Intermedics Orthopedics · Feb 1995
FOUNDATION KNEE AUGMENTATION BLOCKS
K941306 · Encore Orthopedics, Inc. · Feb 1995
POSTERIOR STABILIZED APOLLO KNEE SYSTEM
K935789 · Intermedics Orthopedics · Feb 1995
NEXT GENERATION KNEE SYSTEM
K933785 · Zimmer, Inc. · Jan 1995
OSTEONICS(R) SERIES 7000 TOTAL KNEE
K940813 · Osteonics Corp. · Jan 1995
APOLLO KNEE FEMORAL COMPONENT
K933229 · Intermedics Orthopedics · Jan 1995