Cleared Traditional

K811105 - SEMI-CONSTRAINT KEE JOINT HINGE PROSTH

K811105 is an FDA 510(k) clearance for SEMI-CONSTRAINT KEE JOINT HINGE PROSTH, manufactured by Allo Pro Corp.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K811105 · Allo Pro Corp. · Orthopedic device
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Jul 1981
Decision
95d
Days
Class 2
Risk

K811105 is an FDA 510(k) clearance for the SEMI-CONSTRAINT KEE JOINT HINGE PROSTH. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Allo Pro Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981 after a review of 95 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 Allo Pro Corp. devices

FDA 510(k) Submission Details - K811105

510(k) Number K811105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1981
Decision Date July 27, 1981
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
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.

Regulatory Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 84
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K811105.
NATURALYTE BICARBONATE DIALYSATE 4400
K823115 · Erika, Inc. · Dec 1982
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · C.R. Bard, Inc. · Jun 1982
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
K821340 · Intermedics Orthopedics · May 1982
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
K810520 · Zimmer, Inc. · Mar 1981