Cleared Traditional

K140724 - MSP METATARSAL SHORTENING SYSTEM

K140724 is an FDA 510(k) clearance for MSP METATARSAL SHORTENING SYSTEM, manufactured by Nextremity Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K140724 · Nextremity Solutions, Inc. · Orthopedic device
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May 2014
Decision
54d
Days
Class 2
Risk

K140724 is an FDA 510(k) clearance for the MSP METATARSAL SHORTENING 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 Nextremity Solutions, Inc. (Red Bank, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 54 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 Nextremity Solutions, Inc. devices

FDA 510(k) Submission Details - K140724

510(k) Number K140724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date May 14, 2014
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
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 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140724.
ACUMED HAND FRACTURE SYSTEM
K141383 · Acumed, LLC · Jun 2014
VARIAX 2 COMPRESSION PLATING SYSTEM
K140565 · Stryker Trauma AG · May 2014
SALVATION 3DI PLATING SYSTEM
K140792 · Wrightmedicaltechnologyinc · May 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · Biomet, Inc. · May 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · Aap Implantate AG · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014