Cleared Traditional

K160548 - MC-Subtalar(TM) II

K160548 is an FDA 510(k) clearance for MC-Subtalar(TM) II, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K160548 · Merete Medical GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
60d
Days
Class 2
Risk

K160548 is an FDA 510(k) clearance for the MC-Subtalar(TM) II. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on April 29, 2016 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Merete Medical GmbH devices

FDA 510(k) Submission Details - K160548

510(k) Number K160548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date April 29, 2016
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Technologies, Inc.
MATTHIAS MOLLMANN

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 - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K160548.
Arthrosurface Bone Screws
K161539 · Arthrosurface, Inc. · Jun 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
Large Screws Range
K160617 · Newclip Technics · Jun 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
Tyber Medical Trauma Screw
K153575 · Tyber Medical, LLC · Feb 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
K152187 · Merete Medical GmbH · Feb 2016