Cleared Traditional

K203335 - MectaScrew Extension

K203335 is the FDA 510(k) clearance for MectaScrew Extension by Medacta International S.A.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K203335 · Medacta International S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
448d
Days
Class 2
Risk

K203335 is an FDA 510(k) clearance for the MectaScrew Extension. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on February 3, 2022 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Medacta International S.A. devices

Submission Details

510(k) Number K203335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2020
Decision Date February 03, 2022
Days to Decision 448 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
326d slower than avg
Panel avg: 122d · This submission: 448d
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 Consultant

Medacta USA
Chris Lussier

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 - HWC Screw, Fixation, Bone

All 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203335.
Cannulated Compression Device System
K210146 · Orthopedic Designs North America, Inc. · Apr 2022
Medline UNITE IM Fibula Implant
K220511 · Medline Industries, LP · Mar 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
K212755 · Signus Medizintechnik GmbH · Mar 2022
MIS Precision Chevron Bunion System
K211628 · Relja Innovations, LLC · Jan 2022
JuniOrtho Plating System™
K213572 · Orthofix Srl · Jan 2022
BRM TOOL Screws
K203773 · Brm Extremities Srl · Jan 2022