Cleared Traditional

K151762 - PediatrOS RigidTack/FlexTack

K151762 is an FDA 510(k) clearance for PediatrOS RigidTack/FlexTack, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K151762 · Merete Medical GmbH · Orthopedic device
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Dec 2015
Decision
182d
Days
Class 2
Risk

K151762 is an FDA 510(k) clearance for the PediatrOS RigidTack/FlexTack. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on December 28, 2015 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Merete Medical GmbH devices

FDA 510(k) Submission Details - K151762

510(k) Number K151762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date December 28, 2015
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
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

Merete Medical, Inc.
Matthias Möllmann

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 208
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