Cleared Traditional

K153395 - OS2-C Compression Staple

K153395 is an FDA 510(k) clearance for OS2-C Compression 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 86-day FDA review.

K153395 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
86d
Days
Class 2
Risk

K153395 is an FDA 510(k) clearance for the OS2-C Compression 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 18, 2016 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all In2bones Sas devices

FDA 510(k) Submission Details - K153395

510(k) Number K153395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date February 18, 2016
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 K153395.
EasyStep
K160813 · Stryker GmbH · Jul 2016
First Ray Internal Bone Staple System
K153622 · First Ray, LLC · Apr 2016
OS2(R)-VP Varisation Staple
K153770 · In2bones Sas · Mar 2016
dynaMX Tabbed Staple
K153129 · Mx Orthopedics, Corp. · Jan 2016
PediatrOS RigidTack/FlexTack
K151762 · Merete Medical GmbH · Dec 2015
TiTHON Staple with OsseoTi Technology
K151615 · Biomet Manufacturing Corp · Oct 2015