Cleared Traditional

K121651 - ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM

K121651 is an FDA 510(k) clearance for ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K121651 · Wrightmedicaltechnologyinc · Orthopedic device
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Oct 2012
Decision
129d
Days
Class 2
Risk

K121651 is an FDA 510(k) clearance for the ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 129 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K121651

510(k) Number K121651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date October 12, 2012
Days to Decision 129 days
Submission Type Traditional
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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K121651.
KLS MARTIN RECON TALON
K122860 · KLS-Martin L.P. · Nov 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601 · Aap Implantate AG · Nov 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · Aap Implantate AG · Oct 2012
PIONEER STERNAL CABLE PLATE SYSTEM
K122293 · Pioneer Surgical Technology, Inc. · Oct 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737 · Skeletal Dynamics, LLC · Oct 2012
ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM
K121425 · Wrightmedicaltechnologyinc · Oct 2012