Cleared Special

K071173 - RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D

K071173 is an FDA 510(k) clearance for RESOLVE TONGS, manufactured by Ossur Americans (Formerly the Jerome Group). The device is a Class 2 Neurology device with product code HAX cleared through the Special 510(k) pathway after a 28-day FDA review.

K071173 · Ossur Americans (Formerly the Jerome Group) · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
28d
Days
Class 2
Risk

K071173 is an FDA 510(k) clearance for the RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D. Classified as Tong, Skull For Traction (product code HAX), Class II - Special Controls.

Submitted by Ossur Americans (Formerly the Jerome Group) (Paulsboro, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5960 - the FDA neurology device 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 - K071173

510(k) Number K071173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2007
Decision Date May 25, 2007
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HAX Device Classification - Class 2, Special Controls

Product Code HAX Tong, Skull For Traction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5960
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 Neurology devices follow this clearance model.

Regulatory Peers - HAX Tong, Skull For Traction

All 18
Devices cleared under the same product code (HAX) and FDA review panel - the closest regulatory comparables to K071173.
PMT HALO SYSTEM
K090733 · Pmt Corp. · Jul 2009
RESOLVE OPEN BACK HALO RINGS
K051918 · Jerome Medical · Aug 2005
JEROME GLASS RING
K023959 · The Jerome Group, Inc. · Feb 2003
SPINE WORKS COLLAR
K003662 · Spine Works · Jul 2001
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
K980689 · Friddle'S Orthopedic Appliances, Inc. · Feb 1999
J TONGS
K930021 · Jerome Medical · Dec 1995
K071173 · RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
Download PDF FDA Summary Ossur Americans (Form…