Cleared Traditional

K152312 - RECON system-V-TEK-IVP Plates and Screws

K152312 is an FDA 510(k) clearance for RECON system-V-TEK-IVP Plates and Screws, 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 74-day FDA review.

K152312 · Normed Medizin-Technik GmbH · Orthopedic device
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Oct 2015
Decision
74d
Days
Class 2
Risk

K152312 is an FDA 510(k) clearance for the RECON system-V-TEK-IVP Plates and Screws. 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 October 30, 2015 after a review of 74 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 - K152312

510(k) Number K152312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2015
Decision Date October 30, 2015
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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
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