Cleared Traditional

Responsive Arthroscopy Interference Screw System (K180573) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180573 · Responsive Arthroscopy, LLC · Orthopedic device
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Nov 2018
Decision
263d
Days
Class 2
Risk

K180573 is an FDA 510(k) clearance for the Responsive Arthroscopy Interference Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Responsive Arthroscopy, LLC (Minneapolis, US). The FDA issued a Cleared decision on November 23, 2018 after a review of 263 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Responsive Arthroscopy, LLC devices

Submission Details

510(k) Number K180573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date November 23, 2018
Days to Decision 263 days
Submission Type Traditional
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
141d slower than avg
Panel avg: 122d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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
Benjamin Arnold

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 - HWC Screw, Fixation, Bone

All 415
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180573.
AURORA™ Screw System
K182989 · MiRus, LLC · Dec 2018
ICONN Campbell Interference Screw
K180670 · Iconn Orthopedics, LLC · Dec 2018
Healix™ Compression Screw System
K182949 · Nvision Biomedical Technologies, LLC · Dec 2018
HammerTechTM Fixation System
K182684 · Fusion Orthopedics, LLC · Nov 2018
DePuy Synthes 2.0 mm Quick Insertion Screws
K180541 · Synthes USA Products, LLC · Nov 2018
Two-Step Implant System
K181898 · Trilliant Surgical · Oct 2018