Cleared Special

K091689 - SYNAPSE SYSTEM 4.0MM

K091689 is the FDA 510(k) clearance for SYNAPSE SYSTEM 4.0MM by Synthes (Usa). It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K091689 · Synthes (Usa) · Orthopedic device
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Jul 2009
Decision
30d
Days
Class 2
Risk

K091689 is an FDA 510(k) clearance for the SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 10, 2009 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes (Usa) devices

Submission Details

510(k) Number K091689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2009
Decision Date July 10, 2009
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 261
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K091689.
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295 · Pioneer Surgical Technology · Feb 2010
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · K2m, Inc. · Dec 2009
SENTINEL SPINAL SYSTEM
K090343 · Life Spine · Aug 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · Globus Medical, Inc. · Jun 2009
SYNTHES SYNAPSE TRANSCONNECTOR
K090549 · Synthes Spine · May 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · Medtronic Sofamor Danek · Apr 2009