Cleared Traditional

K123832 - OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME

K123832 is an FDA 510(k) clearance for OIC DISTAL RADIUS PLATING SYSTEM, manufactured by The Orthopaedic Implant Company (Oic). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K123832 · The Orthopaedic Implant Company (Oic) · Orthopedic device
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Mar 2013
Decision
97d
Days
Class 2
Risk

K123832 is an FDA 510(k) clearance for the OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CL.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by The Orthopaedic Implant Company (Oic) (Reno, US). The FDA issued a Cleared decision on March 20, 2013 after a review of 97 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 The Orthopaedic Implant Company (Oic) devices

FDA 510(k) Submission Details - K123832

510(k) Number K123832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date March 20, 2013
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 1052
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123832.
AXSOS 3 TI LOCKING PLATE SYSTEM
K123964 · Stryker Trauma AG · Mar 2013
VARIAX 2 COMPRESSION PLATING SYSTEM
K130009 · Stryker Trauma AG · Mar 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · Stryker Trauma AG · Mar 2013
AAP RADIUS SET 2.5
K123875 · Aap Implantate AG · Mar 2013
SUPERIOR LATERAL VARIAX CLAVICLE PLATE
K130116 · Stryker Trauma AG · Mar 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · CarboFix Orthopedics , Ltd. · Feb 2013