Cleared Special

K071824 - ACME TALON PEDICLE SCREW

K071824 is an FDA 510(k) clearance for ACME TALON PEDICLE SCREW, manufactured by Acme Spine, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 63-day FDA review.

K071824 · Acme Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
63d
Days
Class 2
Risk

K071824 is an FDA 510(k) clearance for the ACME TALON PEDICLE SCREW. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Acme Spine, LLC (Round Rock, US). The FDA issued a Cleared decision on September 4, 2007 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Acme Spine, LLC devices

FDA 510(k) Submission Details - K071824

510(k) Number K071824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date September 04, 2007
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071824.
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NUVASIVE OCT SYSTEM
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SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007