Cleared Special

UNIVERSAL BONE PLATE III SYSTEM (UBP III) (K020611) - FDA 510(k) Clearance

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

K020611 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
30d
Days
Class 2
Risk

K020611 is an FDA 510(k) clearance for the UNIVERSAL BONE PLATE III SYSTEM (UBP III). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on March 27, 2002 after a review of 30 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 Spinal Concepts, Inc. devices

Submission Details

510(k) Number K020611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2002
Decision Date March 27, 2002
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K020611.
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · Synthes (Usa) · Jun 2002
SYNTHES CALCANEAL PLATE
K020401 · Synthes (Usa) · May 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · Biomet, Inc. · Apr 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · Synthes (Usa) · Mar 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · Arthrex, Inc. · Mar 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · Synthes (Usa) · Jan 2002