Company ยท US
Orthohelix Surgical Designs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2014. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2014 | K142148 | ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. | JDR |
| Aug 21, 2014 | K141004 | INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. | HTY |
| Jul 11, 2014 | K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jan 3, 2014 | K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES Orthohelix Surgical Designs, Inc. | HTN |
| Sep 17, 2013 | K132591 | MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Aug 15, 2013 | K130832 | ORTHOHELIX STAPLE SYSTEM Orthohelix Surgical Designs, Inc. | JDR |
| May 31, 2013 | K131324 | MAXTORQUE SCREW SYSTEM Orthohelix Surgical Designs, Inc. | HWC |
| Dec 14, 2012 | K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL Orthohelix Surgical Designs, Inc. | HRS |
| Sep 6, 2012 | K122005 | MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jun 13, 2012 | K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Apr 17, 2012 | K120165 | INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. | HTY |
| Apr 10, 2012 | K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jan 30, 2012 | K113048 | MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jun 6, 2011 | K111041 | MINI VARIABLE SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Sep 30, 2010 | K102156 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS Orthohelix Surgical Designs, Inc. | HRS |
| Sep 27, 2010 | K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Apr 20, 2010 | K100618 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY Orthohelix Surgical Designs, Inc. | HRS |
| Feb 17, 2010 | K093900 | EDGELOCK Orthohelix Surgical Designs, Inc. | HRS |
| Jun 15, 2009 | K090289 | CLAVICLE PLATING SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Dec 8, 2008 | K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc. | HWC |
| Mar 20, 2008 | K073624 | MODULAR FOOT SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Jun 29, 2006 | K061400 | CALCANEAL TRAUMA SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| Mar 7, 2006 | K060428 | CSS CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc. | HWC |
| Feb 27, 2006 | K053182 | DRLOCK DISTAL RADIUS VOLAR SYSTEM Orthohelix Surgical Designs, Inc. | HRS |
| May 27, 2005 | K050868 | MAXLOCK Orthohelix Surgical Designs, Inc. | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2014 | Orthohelix Surgical Designs Inc MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside.
Used during procedures to clear away bone and cartilage within the desired imp Terminated |
LXH | None listed |
| Mar 22, 2013 | Orthohelix Surgical Designs Inc Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit.
Intended to stabilize and aid in fixation of fractures. Terminated |
HTW | None listed |
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | K082574 |
| Oct 9, 2012 | Orthohelix Surgical Designs Inc OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and Terminated |
HWC | K082574 |
| Jan 11, 2012 | Orthohelix Surgical Designs Inc MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY.
Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and Terminated |
HRS | K102156 |
| Aug 29, 2011 | Orthohelix Surgical Designs Inc Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901,
Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusion Terminated |
HRS | K101962 |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 Terminated |
HWX | K060428 |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 Terminated |
HWX | K060428 |
| Nov 26, 2010 | Orthohelix Surgical Designs Inc CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 Terminated |
HWX | K060428 |
| Jun 10, 2010 | Orthohelix Surgical Designs Inc Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256.
Intended as a guide to normal healing and are not intended to replace normal b Terminated |
HWC | K073624 |
| Apr 22, 2010 | Orthohelix Surgical Designs Inc Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.
Used to drill or cut bone prior to implantation of screws Terminated |
HTW | K082574 |
| Apr 15, 2010 | Orthohelix Surgical Designs Inc Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH
The intended use: Used to stabilize and aid in the fixation Terminated |
LXH | None listed |
| Apr 6, 2010 | Orthohelix Surgical Designs Inc MaxTorque Cannulated Screw Model # MSD-010-55-060S Terminated |
HWC | K060428 |
| Dec 19, 2007 | OrthoHelix Surgical Designs Inc DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, D Terminated |
HRS | K053182 |
| Jan 19, 2007 | OrthoHelix Surgical Designs Inc DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS:
6 stainless steel plates (2-lefts, 2-rights, and 1-righ Terminated |
HRS | K053182 |
| Mar 9, 2006 | Orthohelix Surgical Designs Inc MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System. Terminated |
HRS | None listed |