Cleared Traditional

K002517 - USS VAS

K002517 is the FDA 510(k) clearance for USS VAS by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K002517 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
28d
Days
Class 2
Risk

K002517 is an FDA 510(k) clearance for the USS VAS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 12, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 K002517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date September 12, 2000
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 266
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002517.
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000
XIA SPINE SYSTEM
K002505 · Howmedica Osteonics Corp. · Oct 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
K002607 · Depuyacromed · Sep 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · Howmedica Osteonics Corp. · Aug 2000
E-Z LINK CROSS CONNECTOR
K001470 · Depuyacromed · Aug 2000