Cleared Special

TITANIUM HIP TOOL LOCKING PLATE (K072175) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072175 · Orthopedic Sciences, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2007
Decision
15d
Days
Class 2
Risk

K072175 is an FDA 510(k) clearance for the TITANIUM HIP TOOL LOCKING PLATE. 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 August 21, 2007 after a review of 15 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.

View all Orthopedic Sciences, Inc. devices

Submission Details

510(k) Number K072175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date August 21, 2007
Days to Decision 15 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K072175.
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423 · DePuy Orthopaedics, Inc. · Nov 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083 · DePuy Orthopaedics, Inc. · Oct 2007
SMALL BONE WEDGE
K070592 · Wrightmedicaltechnologyinc · Oct 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · Smith & Nephew, Inc. · Aug 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264 · Synthes (Usa) · Jul 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007