Cleared Special

BIOFOAM BONE WEDGE MODEL ASSORTED (K093950) - FDA 510(k) Clearance

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

K093950 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
30d
Days
Class 2
Risk

K093950 is an FDA 510(k) clearance for the BIOFOAM BONE WEDGE MODEL ASSORTED. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 22, 2010 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K093950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2009
Decision Date January 22, 2010
Days to Decision 30 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
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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K093950.
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · DePuy Orthopaedics, Inc. · Feb 2010
EVOLVE EPS ORTHOLOC
K100146 · Wrightmedicaltechnologyinc · Feb 2010
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
K093433 · Howmedica Osteonics Corp. · Jan 2010
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644 · Synthes (Usa) · Dec 2009
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · Howmedica Osteonics Corp. · Nov 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556 · Synthes (Usa) · Nov 2009