Cleared Abbreviated

K221645 - PROstep(TM) MIS 5mm Chamfer Screw System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K221645 · Wright Medical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
256d
Days
Class 2
Risk

K221645 is an FDA 510(k) clearance for the PROstep(TM) MIS 5mm Chamfer Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wright Medical Technology (Memphis, US). The FDA issued a Cleared decision on February 17, 2023 after a review of 256 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wright Medical Technology devices

Submission Details

510(k) Number K221645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date February 17, 2023
Days to Decision 256 days
Submission Type Abbreviated
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
134d slower than avg
Panel avg: 122d · This submission: 256d
Pathway characteristics
Standards-based clearance path.

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 K221645.
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Tyber Medical Trauma Screw
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DynaNail Mini
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Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026