Cleared Special

K141550 - INSTAFIX SHAPE MEMORY FIXATION SYSTEM

K141550 is an FDA 510(k) clearance for INSTAFIX SHAPE MEMORY FIXATION SYSTEM, manufactured by Ot Medical. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 30-day FDA review.

K141550 · Ot Medical · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
30d
Days
Class 2
Risk

K141550 is an FDA 510(k) clearance for the INSTAFIX SHAPE MEMORY FIXATION SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Ot Medical (King Of Prussia, US). The FDA issued a Cleared decision on July 11, 2014 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141550

510(k) Number K141550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2014
Decision Date July 11, 2014
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - JDR Staple, Fixation, Bone

All 222
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K141550.
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