Cleared Special

K050275 - MODIFICATION TO: INION OTPS BIODEGRADABLE PIN

K050275 is an FDA 510(k) clearance for MODIFICATION TO: INION OTPS BIODEGRADAB..., manufactured by Inion , Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 28-day FDA review.

K050275 · Inion , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
28d
Days
Class 2
Risk

K050275 is an FDA 510(k) clearance for the MODIFICATION TO: INION OTPS BIODEGRADABLE PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on March 7, 2005 after a review of 28 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. 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.

View all Inion , Ltd. devices

FDA 510(k) Submission Details - K050275

510(k) Number K050275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date March 07, 2005
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 Peers - HTY Pin, Fixation, Smooth

All 183
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K050275.
SBI K-WIRES
K051605 · Small Bone Innovations, LLC · Aug 2005
ARTHREX BIO-PIN
K050259 · Arthrex, Inc. · May 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · Xtremi-T, LLC · Apr 2005
PINN-ACL CROSSPIN
K043106 · Linvatec Corp. · Jan 2005
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · Hand Innovations, Inc. · Jul 2004
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004