Cleared Special

K063709 - TS-BONE HIP TOOL

K063709 is an FDA 510(k) clearance for TS-BONE HIP TOOL, manufactured by Orthopedic Sciences, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 21-day FDA review.

K063709 · Orthopedic Sciences, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
21d
Days
Class 2
Risk

K063709 is an FDA 510(k) clearance for the TS-BONE HIP TOOL. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthopedic Sciences, Inc. (Seal Beach, US). The FDA issued a Cleared decision on January 4, 2007 after a review of 21 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 - K063709

510(k) Number K063709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date January 04, 2007
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 1315
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063709.
BASAL DORSAL PLATES
K063831 · Newdeal Sas · Feb 2007
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
K063672 · I.T.S. Implantat-Technologie-Systeme GmbH · Feb 2007
INION CPS/OTPS FREEDOMPLATE
K063410 · Inion , Ltd. · Jan 2007
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
K063009 · Praesidia S.R.L. · Dec 2006
HUMERUS LOCKING PLATING SYSTEM
K063095 · Newclip Technics · Dec 2006
I.T.S. PELVIC RECONSTRUCTION SYSTEM
K063166 · I.T.S. Implantat-Technologie-Systeme GmbH · Dec 2006
K063709 · TS-BONE HIP TOOL
Download PDF FDA Summary Orthopedic Sciences, …