Cleared Special

K140925 - ACUMED SUTURE ANCHOR SYSTEM

K140925 is an FDA 510(k) clearance for ACUMED SUTURE ANCHOR SYSTEM, manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 39-day FDA review.

K140925 · Acumed, LLC · Orthopedic device
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May 2014
Decision
39d
Days
Class 2
Risk

K140925 is an FDA 510(k) clearance for the ACUMED SUTURE ANCHOR SYSTEM. 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 Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 39 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 Acumed, LLC devices

FDA 510(k) Submission Details - K140925

510(k) Number K140925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2014
Decision Date May 20, 2014
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 580
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K140925.
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · Smith & Nephew, Inc. · Jul 2014
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K140324 · Depuy Mitek, A Johnson and Johnson Company · Jul 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · Pontis Orthopaedics, LLC · Jun 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · ArthroCare Corporation · May 2014
ICONN ANSWER SUTURE ANCHOR
K132724 · Iconn Orthopedics, LLC · Apr 2014
THREADED PEEK K-WIRE
K133235 · Mtp Solutions, LLC · Apr 2014