Cleared Traditional

K183620 - PROSTEP TBC Implant System

K183620 is the FDA 510(k) clearance for PROSTEP TBC Implant System by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K183620 · Wrightmedicaltechnologyinc · Orthopedic device
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Jun 2019
Decision
162d
Days
Class 2
Risk

K183620 is an FDA 510(k) clearance for the PROSTEP TBC Implant 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 (Memphis, US). The FDA issued a Cleared decision on June 6, 2019 after a review of 162 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K183620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date June 06, 2019
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
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 899
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K183620.
LOQTEQ VA Foot Plates 2.5
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RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388 · Orthofix Srl · Jun 2019
ORTHOLOC™ 2 Lapidus with Rotation System
K190670 · Wrightmedicaltechnologyinc · May 2019
MatrixRIB Fixation System
K190409 · DePuy Synthes · May 2019
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K190415 · MiRus, LLC · Apr 2019