Cleared Traditional

K032534 - SYNTHES AFS (FDA 510(k) Clearance)

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

K032534 · Synthes Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
230d
Days
Class 2
Risk

K032534 is an FDA 510(k) clearance for the SYNTHES AFS. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on April 1, 2004 after a review of 230 days - an extended review 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: 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 Synthes Spine devices

Submission Details

510(k) Number K032534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2003
Decision Date April 01, 2004
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K032534.
Curiteva Porous PEEK Laminoplasty System
K243137 · Curiteva, Inc. · Oct 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784 · Vy Spine, LLC · Oct 2024
Vy Spine™ VyLam™ Laminoplasty System
K232471 · Vy Spine, LLC · Oct 2023
Curiteva Laminoplasty System
K231232 · Curiteva, Inc. · Jun 2023
Centerpiece Plate Fixation System
K212428 · Medtronic Sofamor Danek · Dec 2021