Cleared Traditional

K962190 - PATELLOFEMORAL JOINT PROSTHESIS

K962190 is an FDA 510(k) clearance for PATELLOFEMORAL JOINT PROSTHESIS, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code KRR cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K962190 · Intermedics Orthopedics · Orthopedic device
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Oct 1996
Decision
144d
Days
Class 2
Risk

K962190 is an FDA 510(k) clearance for the PATELLOFEMORAL JOINT PROSTHESIS. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K962190

510(k) Number K962190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date October 28, 1996
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRR Device Classification - Class 2, Special Controls

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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.