Cleared Special

K051032 - TITANIUM-HIP TOOL

K051032 is an FDA 510(k) clearance for TITANIUM-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 31-day FDA review.

K051032 · Orthopedic Sciences, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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May 2005
Decision
31d
Days
Class 2
Risk

K051032 is an FDA 510(k) clearance for the TITANIUM-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 May 23, 2005 after a review of 31 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

FDA 510(k) Submission Details - K051032

510(k) Number K051032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2005
Decision Date May 23, 2005
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K051032.
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · Acumed, LLC · Jul 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · Smith & Nephew, Inc. · Jul 2005
MAXLOCK
K050868 · Orthohelix Surgical Designs, Inc. · May 2005
ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
K051083 · Acumed, LLC · May 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · Synthes (Usa) · Apr 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · Synthes (Usa) · Apr 2005