Cleared Traditional

K151407 - RECON system

K151407 is an FDA 510(k) clearance for RECON system, manufactured by Normed Medizin-Technik GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K151407 · Normed Medizin-Technik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
78d
Days
Class 2
Risk

K151407 is an FDA 510(k) clearance for the RECON 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 Normed Medizin-Technik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on August 12, 2015 after a review of 78 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 Normed Medizin-Technik GmbH devices

FDA 510(k) Submission Details - K151407

510(k) Number K151407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date August 12, 2015
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
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 Peers - HRS Plate, Fixation, Bone

All 1044
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K151407.
Anchorage 2 CP System
K151769 · Stryker GmbH · Oct 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442 · Wrightmedicaltechnologyinc · Sep 2015
Arthrex Fracture Plates
K151732 · Arthrex, Inc. · Aug 2015
Medline Foot Plates and Screws
K151235 · Medline Industries, Inc. · Aug 2015
VariAx 2 One-Third Tubular Plating System
K151879 · Stryker GmbH · Aug 2015
VariAx 2 Wrist Fusion System
K151178 · Stryker Trauma AG · Jun 2015