Cleared Special

NovoStitch Pro Meniscal Repair System (K180531) - FDA 510(k) Clearance

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

K180531 · Ceterix Orthopaedics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
29d
Days
Class 2
Risk

K180531 is an FDA 510(k) clearance for the NovoStitch Pro Meniscal Repair System. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Ceterix Orthopaedics, Inc. (Fremont, US). The FDA issued a Cleared decision on March 29, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device 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 Ceterix Orthopaedics, Inc. devices

Submission Details

510(k) Number K180531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2018
Decision Date March 29, 2018
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Qrac, LLC
Debra Cogan

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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 80
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K180531.
DYNACORD Suture
K181182 · Medos International SARL · Aug 2018
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
K181772 · Ceterix Orthopaedics, Inc. · Aug 2018
SuperBall Meniscal Repair System
K180191 · Arcuro Medical , Ltd. · Jun 2018
ReConnex Pre-Sutured Tendon
K170957 · Allosource · Mar 2018
GRAVITY™ Soft Tissue Repair System
K170642 · Wrightmedicaltechnologyinc · Aug 2017
SutureTape
K171296 · Arthrex, Inc. · May 2017