Cleared Traditional

K922824 - KNEE JT. PATELLO FEMORO TIBIAL POLYMER/...

K922824 is an FDA 510(k) clearance for KNEE JT. PATELLO FEMORO TIBIAL POLYMER/..., manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K922824 · Joint Medical Products Corp. · Orthopedic device
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Sep 1992
Decision
98d
Days
Class 2
Risk

K922824 is an FDA 510(k) clearance for the KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K922824

510(k) Number K922824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1992
Decision Date September 17, 1992
Days to Decision 98 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 103
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K922824.
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