Cleared Traditional

K012762 - MJS POSTERIOR STABILIZED KNEE SYSTEM

K012762 is an FDA 510(k) clearance for MJS POSTERIOR STABILIZED KNEE SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K012762 · Osteoimplant Technology, Inc. · Orthopedic device
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Dec 2001
Decision
116d
Days
Class 2
Risk

K012762 is an FDA 510(k) clearance for the MJS POSTERIOR STABILIZED KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on December 11, 2001 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K012762

510(k) Number K012762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2001
Decision Date December 11, 2001
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 79
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K012762.
UNICONDYLAR KNEE
K020741 · Encore Orthopedics, Inc. · Jun 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · Wrightmedicaltechnologyinc · Mar 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · Biomet Orthopedics, Inc. · Feb 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · Wrightmedicaltechnologyinc · Nov 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · Biomet, Inc. · Jul 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · Biomet, Inc. · Jun 2001