Cleared Special

K181120 - 2.8 mm/3.3 mm PopLok Suture Anchors

K181120 is an FDA 510(k) clearance for 2.8 mm/3.3 mm PopLok Suture Anchors, manufactured by Conmed Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 238-day FDA review.

K181120 · Conmed Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
238d
Days
Class 2
Risk

K181120 is an FDA 510(k) clearance for the 2.8 mm/3.3 mm PopLok 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 Conmed Corporation (Utica, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 238 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K181120

510(k) Number K181120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2018
Decision Date December 21, 2018
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
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 606
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K181120.
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K181120 · 2.8 mm/3.3 mm PopLok Suture Anchors
Download PDF FDA Summary Conmed Corporation