Cleared Traditional

GEO Extremity and Ankle Plating System (K212334) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212334 · Gramercy Extremity Orthopedics, LLC · Orthopedic device
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Sep 2021
Decision
56d
Days
Class 2
Risk

K212334 is an FDA 510(k) clearance for the GEO Extremity and Ankle Plating 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 Gramercy Extremity Orthopedics, LLC (Richardson, US). The FDA issued a Cleared decision on September 21, 2021 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gramercy Extremity Orthopedics, LLC devices

Submission Details

510(k) Number K212334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2021
Decision Date September 21, 2021
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 Consultant

Novus Management Group
Tamala Wampler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K212334.
LOQTEQ Proximal Humerus Plate 3.5 System
K211582 · Aap Implantate AG · Oct 2021
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K203002 · Bonebridge AG · Oct 2021
Anthem Fracture System
K212433 · Globus Medical, Inc. · Oct 2021
Omni Foot and Ankle Plating System
K212297 · Extremity Medical, LLC · Aug 2021
Tyber Medical Anatomical Plating System
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Summit Patella Plating System
K203408 · Endeavor Orthopaedics, LLC · Jul 2021