Cleared Traditional

K003155 - VERTEBRAL BODY REPLACEMENT

K003155 is an FDA 510(k) clearance for VERTEBRAL BODY REPLACEMENT, manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003155 · Osteotech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2001
Decision
86d
Days
Class 2
Risk

K003155 is an FDA 510(k) clearance for the VERTEBRAL BODY REPLACEMENT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 86 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K003155

510(k) Number K003155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date January 04, 2001
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 244
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K003155.
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · Depuyacromed · May 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · Synthes (Usa) · Apr 2001
STACKABLE CAGE SYSTEM
K001340 · Depuyacromed · Jul 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667 · Ionics Medical Corp. · Jul 2000
STACKABLE CAGE SYSTEM
K990148 · Depuy Motech Acromed · Sep 1999