Cleared Special

K222409 - CAPTIVATE® Compression Screws (FDA 510(k) Clearance)

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

K222409 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
29d
Days
Class 2
Risk

K222409 is an FDA 510(k) clearance for the CAPTIVATE® Compression Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on September 8, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K222409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2022
Decision Date September 08, 2022
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K222409.
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · OSSIO , Ltd. · May 2026
TITAN Nail
K260934 · Medartis AG · Apr 2026
CoAptix S System
K252699 · University of Utah, Department of Orthopaedics · Apr 2026
Tyber Medical Trauma Screw
K253042 · Tyber Medical, LLC · Apr 2026
DynaNail Mini
K254110 · MedShape, Inc. · Mar 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · Treace Medical Concepts, Inc. · Mar 2026