Cleared Traditional

K121672 - AFT PROXIMAL HUMERUS FRACTURE PLATE

K121672 is the FDA 510(k) clearance for AFT PROXIMAL HUMERUS FRACTURE PLATE by Shoulder Options, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K121672 · Shoulder Options, Inc. · Orthopedic device
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Oct 2012
Decision
117d
Days
Class 2
Risk

K121672 is an FDA 510(k) clearance for the AFT PROXIMAL HUMERUS FRACTURE 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 Shoulder Options, Inc. (Waxhaw, US). The FDA issued a Cleared decision on October 1, 2012 after a review of 117 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Shoulder Options, Inc. devices

Submission Details

510(k) Number K121672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2012
Decision Date October 01, 2012
Days to Decision 117 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 895
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K121672.
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · Aap Implantate AG · Oct 2012
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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