Cleared Traditional

K143323 - OS2-V Varisation Staple

K143323 is an FDA 510(k) clearance for OS2-V Varisation Staple, manufactured by In2bones Sas. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K143323 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
99d
Days
Class 2
Risk

K143323 is an FDA 510(k) clearance for the OS2-V Varisation Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on February 26, 2015 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 In2bones Sas devices

FDA 510(k) Submission Details - K143323

510(k) Number K143323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date February 26, 2015
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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

Estrin Consulting Group,Llc
NORMAN F. ESTRIN

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 - JDR Staple, Fixation, Bone

All 210
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K143323.
Arcus Staple System
K151160 · Nextremity Solutions, Inc. · Sep 2015
dynaMX Compression Staple
K143622 · Mx Orthopedics, Corp. · Jun 2015
Elite Nitinol Fixation System
K150125 · Biomedical Enterprises, Inc. · May 2015
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
K142111 · Novatsep · Dec 2014
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014