Cleared Special

K142230 - Apollo Suture Anchor System and Titan Screws

K142230 is an FDA 510(k) clearance for Apollo Suture Anchor System and Titan S..., manufactured by Valeris Medical. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 28-day FDA review.

K142230 · Valeris Medical · Orthopedic device
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Sep 2014
Decision
28d
Days
Class 2
Risk

K142230 is an FDA 510(k) clearance for the Apollo Suture Anchor System and Titan Screws. 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 Valeris Medical (Marietta, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 28 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 Valeris Medical devices

FDA 510(k) Submission Details - K142230

510(k) Number K142230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date September 10, 2014
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

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 Consultant

Wagoner Consulting, LLC
Cheryl L Wagoner

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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K142230.
Stabilynx PEEK Suture Anchor
K142643 · D3 Dc, LLC /Stabilynx, Inc. · Dec 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,
K142574 · Depuy Mitek, A Johnson & Johnson Company · Oct 2014
G-Lok and G-Lok XL Extender
K142653 · T.A.G. Medical Products Corporation, Ltd. · Oct 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · Arthrex, Inc. · Aug 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011 · Wrightmedicaltechnologyinc · Jul 2014
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
K141711 · Pontis Orthopaeeics, LLC · Jul 2014