Cleared Traditional

M-COR HIP REPLACEMENT SYSTEM (K053417) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053417 · Portland Orthopaedics Pty. , Ltd. · Orthopedic device
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Jul 2006
Decision
224d
Days
Class 2
Risk

K053417 is an FDA 510(k) clearance for the M-COR HIP REPLACEMENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Portland Orthopaedics Pty. , Ltd. (Stillwater, US). The FDA issued a Cleared decision on July 20, 2006 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Portland Orthopaedics Pty. , Ltd. devices

Submission Details

510(k) Number K053417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2005
Decision Date July 20, 2006
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K053417.
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434 · Howmedica Osteonics Corp. · Aug 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226 · Zimmer, Inc. · Aug 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786 · Zimmer, Inc. · Jul 2006
PCA 36MM FEMORAL HEADS
K061168 · Howmedica Osteonics Corp. · Jul 2006
DEPUY AML HIP PROSTHESIS
K061833 · DePuy Orthopaedics, Inc. · Jul 2006
DYNASTY ACETABULAR SHELL
K061547 · Wrightmedicaltechnologyinc · Jul 2006