Cleared Traditional

K051454 - ALEUTIAN SPACER SYSTEM

K051454 is an FDA 510(k) clearance for ALEUTIAN SPACER SYSTEM, manufactured by K2m, LLC. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K051454 · K2m, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
55d
Days
Class 2
Risk

K051454 is an FDA 510(k) clearance for the ALEUTIAN SPACER SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by K2m, LLC (Leesburg, US). The FDA issued a Cleared decision on July 27, 2005 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all K2m, LLC devices

FDA 510(k) Submission Details - K051454

510(k) Number K051454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date July 27, 2005
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 237
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K051454.
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
K050997 · Flexuspine, Inc. · Oct 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
SEMIAL SPINAL IMPLANT
K051659 · Signus Medizintechnik GmbH · Jul 2005
QUANTUM VERTEBRAL BODY REPLACEMENT
K050449 · Quantum Orthopedics, Inc. · Jul 2005
MC+ PARTIAL VBR
K043479 · Ldr Spine USA · Jun 2005