Ortho Development Corp.
Medical device manufacturer in Draper, UT.
64510(k) clearances
0PMA approvals
23recalls
Device types
- JWH Prosthesis, Knee, Patellofemorotibial… 15
- LPH Prosthesis, Hip, Semi-Constrained… 13
- LZO Prosthesis, Hip, Semi-Constrained… 6
- KWY Prosthesis, Hip, Hemi-, Femoral… 5
- JDI Prosthesis, Hip, Semi-Constrained… 4
- NKB Thoracolumbosacral Pedicle Screw System 4
- MEH Prosthesis, Hip, Semi-Constrained… 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
- MBH Prosthesis, Knee, Patello/Femorotibial… 1
- HSB Rod, Fixation, Intramedullary And Accessories 1
- HSX Prosthesis, Knee, Femorotibial… 1
- OWI Bone Fixation Cerclage, Sublaminar 1
- ODP Intervertebral Fusion Device With Bone… 1
- MAX Intervertebral Fusion Device With Bone… 1
- MQP Spinal Vertebral Body Replacement Device 1
- MNH Orthosis, Spondylolisthesis Spinal Fixation 1
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 1
- KWQ Appliance, Fixation, Spinal Intervertebral… 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- KNW Instrument, Biopsy 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | 12/19/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | 05/22/2025SE |
| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
| K211471 | Balanced Knee System UniHSX · Traditional | 12/16/2021SE |
| K203023 | Pisces Spinal SystemNKB · Traditional | 07/14/2021SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone AugmentsJWH · Traditional | 10/31/2018SE |
| K181569 | BKS Revision Sleeves SystemJWH · Traditional | 10/12/2018SE |
| K180743 | Balanced Knee Revision System - Offset Junction BoxJWH · Traditional | 06/20/2018SE |
| K173951 | Legend Acetabular LinersLPH · Special | 05/30/2018SE |
| K171249 | Entrada hip stemMEH · Traditional | 08/24/2017SE |
| K162995 | Ibis® Pedicle Screw SystemNKB · Traditional | 03/30/2017SE |
| K161080 | Escalade Legend Acetabular ShellLPH · Special | 05/17/2016SE |
| K153216 | Alpine Cemented Hip SystemJDI · Traditional | 02/18/2016SE |
| K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsJWH · Traditional | 10/27/2015SE |
| K142146 | Ibis Pedicle Screw SystemNKB · Traditional | 12/11/2014SE |
| K141001 | Alpine Hip Stem; Alpine Ha Hip StemLPH · Traditional | 07/30/2014SE |
| K132697 | Encompass 10/12 Hip StemLPH · Traditional | 06/20/2014SE |
| K133386 | Ovation Tribute Hip Stem; Ovation Narrow Hip StemLPH · Traditional | 03/11/2014SE |
| K133449 | Kasm Knee Articulating Spacer MoldsJWH · Traditional | 02/18/2014SE |
| K131022 | Ovation 10/12 Hip StemLPH · Traditional | 10/16/2013SE |
| K131337 | Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaJWH · Traditional | 10/11/2013SE |
| K131785 | Pagoda Pedicle Screw SystemNKB · Traditional | 08/20/2013SE |
| K122588 | Vusion CS PlusODP · Traditional | 06/12/2013SE |
| K123457 | Balanced Knee System High Flex PSJWH · Traditional | 03/22/2013SE |
| K111965 | Vusion(R) OsMAX · Traditional | 10/25/2011SE |
| K111936 | Ortho Devlopment Ceramic Femoral HeadLZO · Special | 09/21/2011SE |
| K103837 | Balanced Knee System Revision Offset TibiaJWH · Traditional | 03/24/2011SE |
| K103384 | Escalade Acetabular Cup SystemLPH · Traditional | 03/16/2011SE |
| K090705 | Balanced Knee System Ultracongruent Tibial InsertJWH · Traditional | 10/09/2009SE |
| K062171 | Emf Pal II Main Generator and Irrigation Units and AccessoriesGEI · Traditional | 05/25/2007SE |
| K062666 | Vusion TS, PS, and CS Partial Vertebral Body ReplacementsMQP · Traditional | 01/25/2007SE |
| K062775 | European Style Taper,Press-Fit Hip StemLPH · Traditional | 01/16/2007SE |
| K061524 | Iss Integrated Spine SystemMNH · Traditional | 09/26/2006SE |
| K060569 | Balanced Knee System Modular Revision Knee SystemJWH · Traditional | 07/06/2006SE |
| K060577 | Ortho Development Ceramic Femoral HeadsLZO · Traditional | 04/28/2006SE |
| K053587 | Ortho Development Ceramic Femoral Heads with Pres-Fit StemsLZO · Traditional | 03/17/2006SE |
| K053293 | Encompass 10*17 and 12*17 Extended Press-Fit Hip StemsLPH · Traditional | 02/16/2006SE |
| K050637 | Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral HeadsJDI · Traditional | 09/23/2005SE |
| K051407 | Legend All-Poly CupJDI · Traditional | 09/08/2005SE |
| K050966 | Pivot Bipolar Femoral HeadKWY · Traditional | 07/07/2005SE |
| K042565 | Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM LinerLPH · Traditional | 04/11/2005SE |
| K042973 | Solitude Unipolar HeadKWL · Traditional | 01/27/2005SE |
| K031201 | Ortho Development Balanced Knee Modular Tibial SystemJWH · Traditional | 07/15/2003SE |
| K020383 | Ortho Development Balanced Knee Tibial Tray PeggedJWH · Traditional | 05/06/2002SE |
| K020649 | Envision Anterior Cervical Plate SystemKWQ · Traditional | 04/05/2002SE |
| K012129 | Ortho Development Orion-I Emf SystemGEI · Traditional | 08/22/2001SE |
| K000321 | Hemisphere Modular Cup SystemLPH · Traditional | 04/10/2000SE |
| K994370 | Ortho Development Balanced Knee SystemJWH · Traditional | 03/24/2000SE |
| K990986 | Contour Spinal SystemKWP · Traditional | 10/14/1999SE |
| K982389 | Odc B2 Bipolar CupKWY · Traditional | 10/07/1998SE |
| K974158 | Orion Medical Inc. Disposable Brain Biopsy Needle for Sterotactic Guided BiopsyKNW · Traditional | 12/09/1997SE |
| K970675 | Headloc Ceramic HeadLZO · Traditional | 08/22/1997SE |
| K971581 | Hemisphere Cemented CupJDI · Traditional | 07/18/1997SE |
| K971435 | Headloc Ceramic Femoral HeadsLZO · Traditional | 07/09/1997SE |
| K971426 | Headloc Ceramic HeadLZO · Traditional | 07/09/1997SN |
| K962448 | Primaloc Cemented Hip SystemKWY · Traditional | 09/19/1996SN |
| K961793 | Bi-Loc Bipolar CupKWY · Traditional | 07/26/1996SE |
| K960660 | Hemisphere Acetabular CupLPH · Traditional | 05/08/1996SE |
| K953977 | Primaloc Cementless Hip SystemKWY · Traditional | 01/26/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1904-2020 Class II | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut… | 05/30/2019Open, Classified |
| Z-1903-2020 Class II | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut… | 05/30/2019Open, Classified |
| Z-2257-2014 Class II | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2256-2014 Class II | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2255-2014 Class II | PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2254-2014 Class II | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-2253-2014 Class II | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a…Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and… | 07/11/2014Terminated |
| Z-1610-2014 Class II | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee…A femoral component containing pegs was found in a box for the pegless version. | 04/01/2014Terminated |
| Z-0740-2012 | U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup…Tip of hex-head screwdriver may break off during use in hip replacement procedure. | 12/19/2011Terminated |
| Z-2603-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho…Tests on PVC packaging material resulted in alert levels for cytotoxicity. | 05/10/2011Terminated |
| Z-2602-2011 | Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho…Tests on PVC packaging material resulted in alert levels for cytotoxicity. | 05/10/2011Terminated |
| Z-1673-2011 | Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho…Component of total hip arthroplasty may break during surgical procedure. | 01/11/2011Terminated |
| Z-1672-2011 | Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development…Component of total hip arthroplasty may break during surgical procedure. | 01/11/2011Terminated |
| Z-1671-2011 | Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development…Component of total hip arthroplasty may break during surgical procedure. | 01/11/2011Terminated |
| Z-1670-2011 | Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development…Component of total hip arthroplasty may break during surgical procedure. | 01/11/2011Terminated |
| Z-1742-2011 | UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah…Components of a replacement knee system could be mislabeled. | 01/07/2011Terminated |
| Z-1741-2011 | CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah…Components of a replacement knee system could be mislabeled. | 01/07/2011Terminated |
| Z-1740-2011 | UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah…Components of a replacement knee system could be mislabeled. | 01/07/2011Terminated |
| Z-0315-2011 | Distal Centralizer 10 mmThe hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper. | 07/28/2010Terminated |
| Z-1993-2009 | Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R…Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were… | 05/29/2009Terminated |
| Z-0086-2010 | Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a… | 04/29/2009Terminated |
| Z-1229-2010 | 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The…A component of knee prosthesis was assembled incorrectly. | 03/19/2009Terminated |
| Z-1228-2010 | 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial…A component of knee prosthesis was assembled incorrectly. | 03/19/2009Terminated |