Cleared Traditional

K023087 - GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

K023087 is an FDA 510(k) clearance for GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS), manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023087 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2002
Decision
90d
Days
Class 2
Risk

K023087 is an FDA 510(k) clearance for the GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS). Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 90 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K023087

510(k) Number K023087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2002
Decision Date December 16, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 81
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K023087.
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · Biomet, Inc. · Dec 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · Howmedica Osteonics Corp. · Jul 2003
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · Plus Orthopedics · Dec 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · Wrightmedicaltechnologyinc · Dec 2002
RT-PLUS PE INSERT CLAMP
K021714 · Plus Orthopedics · Jun 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · Biomet, Inc. · Jun 2002