Cleared Traditional

K781971 - KNEE SYSTEM, QUADRAXIAL CONSTRAINED

K781971 is an FDA 510(k) clearance for KNEE SYSTEM, manufactured by Hexcel Medical. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K781971 · Hexcel Medical · Orthopedic device
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Apr 1979
Decision
128d
Days
Class 2
Risk

K781971 is an FDA 510(k) clearance for the KNEE SYSTEM, QUADRAXIAL CONSTRAINED. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Hexcel Medical (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 Hexcel Medical devices

FDA 510(k) Submission Details - K781971

510(k) Number K781971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date April 04, 1979
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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.