Cleared Traditional

K190970 - PROSTEP™ TBI™ (Tailors Bunion Implant) System (FDA 510(k) Clearance)

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

K190970 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2019
Decision
123d
Days
Class 2
Risk

K190970 is an FDA 510(k) clearance for the PROSTEP™ TBI™ (Tailors Bunion Implant) System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on August 13, 2019 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

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Submission Details

510(k) Number K190970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2019
Decision Date August 13, 2019
Days to Decision 123 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1054
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K190970.
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Tyber Medical Trauma Screw
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Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026