Cleared Special

K091190 - UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063

K091190 is an FDA 510(k) clearance for UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, manufactured by Zimmer Spine, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Special 510(k) pathway after a 98-day FDA review.

K091190 · Zimmer Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
98d
Days
Class 2
Risk

K091190 is an FDA 510(k) clearance for the UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Austin, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091190

510(k) Number K091190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date July 30, 2009
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 130
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K091190.
COMPRESSYN BAND
K101484 · Dallen Medical · Apr 2011
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
K102834 · Kinamed, Incorporated · Jan 2011
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
K090686 · Sic Brevetti S.R.L. · Dec 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622 · Abbott Spine, Inc. · Aug 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · Synthes (Usa) · Jul 2008
BIOMET CABLE SYSTEM
K071271 · Biomet Manufacturing, Inc. · Oct 2007
K091190 · UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
Download PDF FDA Summary Zimmer Spine, Inc.