Cleared Special

K193245 - Dunamis PunchTac Suture Anchors

K193245 is the FDA 510(k) clearance for Dunamis PunchTac Suture Anchors by Dunamis, LLC. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 81-day FDA review.

K193245 · Dunamis, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
81d
Days
Class 2
Risk

K193245 is an FDA 510(k) clearance for the Dunamis PunchTac Suture Anchors. 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 Dunamis, LLC (Greenville, US). The FDA issued a Cleared decision on February 14, 2020 after a review of 81 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 Dunamis, LLC devices

Submission Details

510(k) Number K193245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date February 14, 2020
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 Consultant

Mcra, LLC
Hollace Rhodes

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 390
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K193245.
Apollo Suture Anchor System
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K193165 · Medacta International S.A. · Feb 2020
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K191677 · Medacta International S.A. · Jan 2020