Cleared Traditional

K024364 - SYNTHES VERTEBRAL SPACER TI (CURVED AND...

K024364 is the FDA 510(k) clearance for SYNTHES VERTEBRAL SPACER TI (CURVED AND... by Synthes (Usa). It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K024364 · Synthes (Usa) · Orthopedic device
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Mar 2003
Decision
76d
Days
Class 2
Risk

K024364 is an FDA 510(k) clearance for the SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW). Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 17, 2003 after a review of 76 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 Synthes (Usa) devices

Submission Details

510(k) Number K024364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2002
Decision Date March 17, 2003
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K024364.
DEPUY ACROMED VBR SYSTEM
K030833 · Depuyacromed · Apr 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · Medtronic Sofamor Danek · Apr 2003
VERTE-STACK SPINAL SYSTEM
K030601 · Medtronic Sofamor Danek · Mar 2003
NUVASIVE MASH
K023319 · Nuvasive, Inc. · Mar 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · Medtronic Sofamor Danek, Inc. · Feb 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · Depuyacromed · Feb 2003