Cleared Traditional

K160995 - NEOVIEW Plating System

K160995 is an FDA 510(k) clearance for NEOVIEW Plating System, manufactured by In2bones Sas. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K160995 · In2bones Sas · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
63d
Days
Class 2
Risk

K160995 is an FDA 510(k) clearance for the NEOVIEW Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on June 10, 2016 after a review of 63 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 - K160995

510(k) Number K160995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2016
Decision Date June 10, 2016
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1305
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K160995.
Biomet Microfixation Sternal Closure System
K161896 · Biomet Microfixation · Aug 2016
Conventus Orthopaedics Ulna Fixation System
K161048 · Conventus Orthopaedics, Inc. · Jul 2016
CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
K153374 · Orthocare · Jun 2016
AxSOS 3Ti
K153379 · Stryker GmbH · May 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · Osteomed · May 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016