Cleared Special

K242296 - VersaTap™ Suture Anchor (ADP050) (FDA 510(k) Clearance)

Also includes:
VersaPEEK™ Suture Anchor (APP002) MicroTi™ Suture Anchor (ATP003-M) VersaLat™ Ti Suture Anchor (ADP021-TI) VersaLat™ Suture Anchor (ADP021-PK)

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

K242296 · Ortho-Design (Pty), Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
27d
Days
Class 2
Risk

K242296 is an FDA 510(k) clearance for the VersaTap™ Suture Anchor (ADP050). Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Ortho-Design (Pty), Ltd. (Hazelwood, ZA). The FDA issued a Cleared decision on August 29, 2024 after a review of 27 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 Ortho-Design (Pty), Ltd. devices

Submission Details

510(k) Number K242296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2024
Decision Date August 29, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 590
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K242296.
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · Tigon Medical · Apr 2026
Arthrex FiberTak Suture Anchor
K260561 · Arthrex, Inc. · Mar 2026
Grappler Suture Anchor PCFD Tether System
K253886 · Paragon 28, Inc. · Mar 2026
SINEFIX
K254176 · BAAT Medical Products B.V. · Mar 2026
Trax EX Anchor
K251750 · Trax Surgical, Inc. · Mar 2026