Cleared Traditional

K810520 - INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL

K810520 is an FDA 510(k) clearance for INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K810520 · Zimmer, Inc. · Orthopedic device
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Mar 1981
Decision
28d
Days
Class 2
Risk

K810520 is an FDA 510(k) clearance for the INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1981 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K810520

510(k) Number K810520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1981
Decision Date March 26, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
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.