Cleared Special

K181026 - OsteoBridge™ IDSF System

K181026 is an FDA 510(k) clearance for OsteoBridge IDSF System, manufactured by Merete GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 182-day FDA review.

K181026 · Merete GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
182d
Days
Class 2
Risk

K181026 is an FDA 510(k) clearance for the OsteoBridge™ IDSF System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Merete GmbH (Berlin, DE). The FDA issued a Cleared decision on October 17, 2018 after a review of 182 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K181026

510(k) Number K181026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2018
Decision Date October 17, 2018
Days to Decision 182 days
Submission Type Special
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
60d slower than avg
Panel avg: 122d · This submission: 182d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K181026.
Affixus Natural Nail System Humeral Nail
K181827 · Zimmer GmbH · Dec 2018
Affixus Hip Fracture Nail
K183162 · Biomet, Inc. · Dec 2018
Panta 2 Arthrodesis Nail System
K181639 · Integra LifeSciences Corporation · Nov 2018
X-BOLT Hip Fracture Fixation System
K181640 · X-Bolt Orthopaedics · Oct 2018
Double Medical Femoral Nail System
K172830 · Double Medical Technology, Inc. · Aug 2018
OIC Intramedullary Nail System
K181184 · The Orthopaedic Implant Company · Jul 2018
K181026 · OsteoBridge™ IDSF System
Download PDF FDA Summary Merete GmbH