Cleared Special

Responsive Arthroscopy Suture Anchor System (K202153) - FDA 510(k) Clearance

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

K202153 · Responsive Arthroscopy, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
37d
Days
Class 2
Risk

K202153 is an FDA 510(k) clearance for the Responsive Arthroscopy 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 Responsive Arthroscopy, LLC (Minneapolis, US). The FDA issued a Cleared decision on September 9, 2020 after a review of 37 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 Responsive Arthroscopy, LLC devices

Submission Details

510(k) Number K202153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date September 09, 2020
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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

Cor Medical Ventures, LLC
Kristen Pena

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 321
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K202153.
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
K202193 · S.B.M. Sas (Science & Bio Materials) · Oct 2020
Flower Suture Anchor Set
K192949 · Flower Orthopedics Corporation · Oct 2020
OrthoButton FL
K202399 · Riverpoint Medical · Sep 2020
ATL Anchors
K200503 · International Life Sciences · Sep 2020
Hercules Suture Anchor System
K201636 · In2bones USA, LLC · Aug 2020
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
K201883 · Medos International SARL · Aug 2020