Cleared Traditional

K190970 - PROSTEP™ TBI™ (Tailors Bunion Implant) System

K190970 is an FDA 510(k) clearance for PROSTEP TBI (Tailors Bunion Implant) System, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

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.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K190970

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K190970.
TDM Screw Systems
K190830 · Tdm Co., Ltd. · Sep 2019
Interphalangeal Joint Fusion Device Range
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CrossRoads Screw System
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Bone Screw Line Addition
K191289 · Vilex IN Tennessee, Inc. · Jul 2019
ActivOrtho Continuous Compression Screw System
K191817 · Activortho, Inc. · Jul 2019
OrthoPediatrics Cannulated Screw System
K190324 · OrthoPediatrics Corp. · Jul 2019