Cleared Traditional

Summit Patella Plating System (K203408) - FDA 510(k) Clearance

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

K203408 · Endeavor Orthopaedics, LLC · Orthopedic device
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Jul 2021
Decision
253d
Days
Class 2
Risk

K203408 is an FDA 510(k) clearance for the Summit Patella 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 Endeavor Orthopaedics, LLC (Tulsa, US). The FDA issued a Cleared decision on July 30, 2021 after a review of 253 days - an extended review 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: 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 Endeavor Orthopaedics, LLC devices

Submission Details

510(k) Number K203408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2020
Decision Date July 30, 2021
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
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

Allegiance Regulatory Consulting, LLC
Alyssa Thomas

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 700
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K203408.
GEO Extremity and Ankle Plating System
K212334 · Gramercy Extremity Orthopedics, LLC · Sep 2021
Omni Foot and Ankle Plating System
K212297 · Extremity Medical, LLC · Aug 2021
Tyber Medical Anatomical Plating System
K203817 · Tyber Medical, LLC · Aug 2021
FINE Osteotomy
K211646 · Bodycad Laboratories, Inc. · Jul 2021
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
K210016 · Integra LifeSciences Corporation · Jul 2021
Avanti Orthopaedics Ulnar Shortening System
K211592 · Avanti Orthopaedics, Inc. · Jul 2021