Cleared Traditional

K830726 - MARK I & II TOTAL KNEE REPLACE. SYS

K830726 is an FDA 510(k) clearance for MARK I & II TOTAL KNEE REPLACE. SYS, manufactured by Advanced Biosearch Assn.. The device is a Class 2 Orthopedic device with product code MBV cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K830726 · Advanced Biosearch Assn. · Orthopedic device
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Jun 1983
Decision
106d
Days
Class 2
Risk

K830726 is an FDA 510(k) clearance for the MARK I & II TOTAL KNEE REPLACE. SYS. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (product code MBV), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Walker, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Advanced Biosearch Assn. devices

FDA 510(k) Submission Details - K830726

510(k) Number K830726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date June 22, 1983
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBV Device Classification - Class 2, Special Controls

Product Code MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

All 13
Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K830726.
TRICON M TOTAL KNEE SYSTEM
K833200 · Richards Medical Co., Inc. · Nov 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
MARK I TOTAL KNEE SYS. ARTHROPLASTY
K832302 · Advanced Biosearch Assn. · Aug 1983
RMC TOTAL KNEE SYSTEM
K823837 · Richard'S Medical Equip., Inc. · Mar 1983
FREEMAN/SAMUELSON TOTAL KNEE
K830408 · Depuy, Inc. · Feb 1983
TOTAL KNEE SYSTEM
K822583 · Richard'S Medical Equip., Inc. · Oct 1982