Cleared Special

K122623 - SHORT LATERAL SUPERIOR CLAVICLE PLATE

Also marketed or referenced as:
6 HOLE MEDIUM MIDSHAFT

K122623 is the FDA 510(k) clearance for SHORT LATERAL SUPERIOR CLAVICLE PLATE by Advanced Orthopaedic Solutions, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K122623 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
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Sep 2012
Decision
29d
Days
Class 2
Risk

K122623 is an FDA 510(k) clearance for the SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) A.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on September 26, 2012 after a review of 29 days - a notably fast clearance cycle.

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. 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 Advanced Orthopaedic Solutions, Inc. devices

Submission Details

510(k) Number K122623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date September 26, 2012
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

All 886
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K122623.
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · Aap Implantate AG · Oct 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651 · Wrightmedicaltechnologyinc · Oct 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425 · Wrightmedicaltechnologyinc · Oct 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
K113648 · Aap Implantate AG · Sep 2012
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
K113652 · Aap Implantate AG · Aug 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · Acumed, LLC · Jul 2012