Cleared Special

K120903 - CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

K120903 is an FDA 510(k) clearance for CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 ..., manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 109-day FDA review.

K120903 · Acumed, LLC · Orthopedic device
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Jul 2012
Decision
109d
Days
Class 2
Risk

K120903 is an FDA 510(k) clearance for the CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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.

View all Acumed, LLC devices

FDA 510(k) Submission Details - K120903

510(k) Number K120903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date July 13, 2012
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

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