Cleared Special

K081622 - UNIVERSAL CLAMP STAINLESS STEEL SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081622 · Abbott Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
80d
Days
Class 2
Risk

K081622 is an FDA 510(k) clearance for the UNIVERSAL CLAMP STAINLESS STEEL SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Abbott Spine, Inc. (Austin, US). The FDA issued a Cleared decision on August 29, 2008 after a review of 80 days - a notably fast clearance cycle.

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. 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 Abbott Spine, Inc. devices

Submission Details

510(k) Number K081622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2008
Decision Date August 29, 2008
Days to Decision 80 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 128
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K081622.
Stitch Cerclage – Suture Tapes
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Arthrex FiberTape and TigerTape Cerclage Sutures
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Mbrace Cable
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ACCORD Cable System
K233949 · Smith & Nephew, Inc. · Mar 2024
VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · Arthrex, Inc. · Aug 2023