Axsos Plus Locking Plate System

• 2 recalls, same reason

  • Terminated Z-1063-2009 FDA Unclassified (pre-2012) ·initiated 24 Nov 2008
  • Terminated Z-1062-2009 FDA Unclassified (pre-2012) ·initiated 24 Nov 2008

  Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

1. 19 May 2006 Cleared FDA 510(k) K061012
2. 24 Nov 2008 Recall initiated FDA recalls Z-1063-2009
3. 24 Nov 2008 Recall initiated FDA recalls Z-1062-2009

510(k) Number

K061012 ↗

FDA product code

HRS

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code HRS (Plate, Fixation, Bone).

• Epic Extremity Plate System by Epic Extremity, LLC
• SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES by Synthes (Usa)
• Arthrex® AR-18720VCL-32 by Arthrex, Inc.
• Arthrex® AR-8940-58 by Arthrex, Inc.
• OTI EUROPEAN COMPRESSION SYSTEM by Osteo Technology, Inc.
• VARIAX 622098 by Stryker GmbH
• GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive by GPC Medical Limited
• OsteoMed 336-0006-SP-02 by Osteomed Corp.
• ORTHOLOC 3Di 58130006 by WRIGHT MEDICAL TECHNOLOGY, INC.
• RIBFIX BLU SYSTEM 76-2710 by BIOMET MICROFIXATION, INC

• Exeter® Contemporary™

  Class III

  CE/MDR

• Mrh

  Class IIa

  CE/MDR

• Exeter

  Class IIa

  CE/MDR

• Instrument

  Class I

  CE/MDR

See all devices from Howmedica Osteonics Corp. →