Cleared Traditional

K023087 - GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

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

K023087 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 70
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