Company · US
Ortho Development Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2025. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (1 in 12 months)
28recalls (0 in 12 months)
26recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 29 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 13 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 8 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 |
| KNW | Instrument, Biopsy | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2025 | K253161 | Balanced Knee System TriMax Porous Femoral Components Ortho Development Corp. | MBH |
| May 22, 2025 | K251052 | Trivicta® Hip Stem Ortho Development Corp. | MEH |
| Oct 25, 2024 | K242984 | BKS Revision System Ortho Development Corp. | JWH |
| Oct 11, 2024 | K242833 | Legend® Acetabular Shell Ortho Development Corp. | LPH |
| Mar 8, 2024 | K233758 | Trivicta Hip Stem Ortho Development Corp. | MEH |
| Oct 25, 2023 | K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert Ortho Development Corporation | JWH |
| Dec 21, 2021 | K211086 | The Progen Trochanteric Nail System Ortho Development Corporation | HSB |
| Dec 16, 2021 | K211471 | Balanced Knee System Uni Ortho Development Corporation | HSX |
| Jul 14, 2021 | K203023 | Pisces Spinal System Ortho Development Corporation | NKB |
| Mar 31, 2020 | K200281 | The Gecko Spinal System Ortho Development Corporation | OWI |
| Oct 31, 2018 | K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments Ortho Development Corporation | JWH |
| Oct 12, 2018 | K181569 | BKS Revision Sleeves System Ortho Development Corporation | JWH |
| Jun 20, 2018 | K180743 | Balanced Knee Revision System - Offset Junction Box Ortho Development Corporation | JWH |
| May 30, 2018 | K173951 | Legend Acetabular Liners Ortho Development Corporation | LPH |
| Aug 24, 2017 | K171249 | Entrada hip stem Ortho Development Corporation | MEH |
| Mar 30, 2017 | K162995 | Ibis® Pedicle Screw System Ortho Development Corporation | NKB |
| May 17, 2016 | K161080 | Escalade Legend Acetabular Shell Ortho Development Corporation | LPH |
| Feb 18, 2016 | K153216 | Alpine Cemented Hip System Ortho Development Corporation | JDI |
| Oct 27, 2015 | K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts Ortho Development Corporation | JWH |
| Dec 11, 2014 | K142146 | IBIS PEDICLE SCREW SYSTEM Ortho Development Corp. | NKB |
| Jul 30, 2014 | K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM Ortho Development | LPH |
| Jun 20, 2014 | K132697 | ENCOMPASS 10/12 HIP STEM Ortho Development Corp. | LPH |
| Mar 11, 2014 | K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM Ortho Development Corp. | LPH |
| Feb 18, 2014 | K133449 | KASM KNEE ARTICULATING SPACER MOLDS Ortho Development Corp. | JWH |
| Oct 16, 2013 | K131022 | OVATION 10/12 HIP STEM Ortho Development Corp. | LPH |
| Oct 11, 2013 | K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA Ortho Development Corp. | JWH |
| Aug 20, 2013 | K131785 | PAGODA PEDICLE SCREW SYSTEM Ortho Development Corp. | NKB |
| Jun 12, 2013 | K122588 | VUSION CS PLUS Ortho Development Corp. | ODP |
| Mar 22, 2013 | K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS Ortho Development Corp. | JWH |
| Oct 25, 2011 | K111965 | VUSION(R) OS Ortho Development | MAX |
| Sep 21, 2011 | K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD Ortho Development | LZO |
| Mar 24, 2011 | K103837 | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA Ortho Development | JWH |
| Mar 16, 2011 | K103384 | ESCALADE ACETABULAR CUP SYSTEM Ortho Development | LPH |
| Oct 9, 2009 | K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT Ortho Development Corp. | JWH |
| May 25, 2007 | K062171 | EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES Ortho Development Corp. | GEI |
| Jan 25, 2007 | K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS Ortho Development Corp. | MQP |
| Jan 16, 2007 | K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM Ortho Development Corp. | LPH |
| Sep 26, 2006 | K061524 | ISS INTEGRATED SPINE SYSTEM Ortho Development Corp. | MNH |
| Jul 6, 2006 | K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM Ortho Development Corp. | JWH |
| Apr 28, 2006 | K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS Ortho Development Corp. | LZO |
| Mar 17, 2006 | K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS Ortho Development Corp. | LZO |
| Feb 16, 2006 | K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS Ortho Development Corp. | LPH |
| Sep 23, 2005 | K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS Ortho Development Corp. | JDI |
| Sep 8, 2005 | K051407 | LEGEND ALL-POLY CUP Ortho Development Corp. | JDI |
| Jul 7, 2005 | K050966 | PIVOT BIPOLAR FEMORAL HEAD Ortho Development Corp. | KWY |
| Apr 11, 2005 | K042565 | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER Ortho Development Corp. | LPH |
| Jan 27, 2005 | K042973 | SOLITUDE UNIPOLAR HEAD Ortho Development Corp. | KWL |
| Jul 15, 2003 | K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM Ortho Development Corp. | JWH |
| May 6, 2002 | K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED Ortho Development Corp. | JWH |
| Apr 5, 2002 | K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM Ortho Development Corp. | KWQ |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2019 | Ortho Development Corporation Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A
Material: Ti6Al4V. Open, Classified |
JWH | K994370 |
| May 30, 2019 | Ortho Development Corporation Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. Open, Classified |
JWH | K994370 |
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY
Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the fem Terminated |
JWH | K060569 |
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert UC, Balanced Knee System, REF163-3YYY
Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | K090705 |
| Aug 17, 2014 | Ortho Development Corporation PS Tibial Insert, REF 163-1XXX
Product Usage:
UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | K994370 |
| Aug 17, 2014 | Ortho Development Corporation Patella 38mm, REF164-0038
Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component Terminated |
JWH | K994370 |
| Aug 17, 2014 | Ortho Development Corporation Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY
Product Usage:
Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum Terminated |
KWY | K050966 |
| May 13, 2014 | Ortho Development Corporation PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. Terminated |
JWH | K994370 |
| Jan 13, 2012 | Ortho Development Corporation U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Ac Terminated |
LZO | K103384 |
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | K053293 |
| Jun 20, 2011 | Ortho Development Corporation Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
Intended for use in total hip arthroscopy. Device fixation is achieved by an o Terminated |
MBL | K053293 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem ins Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an Terminated |
LZO | K062775 |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Jan 7, 2011 | Ortho Development Corporation CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Jan 7, 2011 | Ortho Development Corporation UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020.
The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base Terminated |
JWH | K060569 |
| Nov 3, 2010 | Ortho Development Corporation Distal Centralizer 10 mm Terminated |
KWY | K962448 |
| Apr 5, 2010 | Ortho Development Corporation 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from sever Terminated |
JWH | K031201 |
| Apr 5, 2010 | Ortho Development Corporation 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from Terminated |
JWH | K031201 |
| Oct 28, 2009 | Ortho Development Corporation Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head. Terminated |
KWY | K050966 |
| Sep 9, 2009 | Ortho Development Corporation Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020.
The Balanced Knee System is indicated in the salva Terminated |
JWH | K994370 |
| Oct 15, 2003 | Ortho Development Corporation Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. Terminated |
JWH | None listed |
| Feb 25, 2003 | Ortho Development Corporation Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.) Terminated |
None listed | |
| Feb 25, 2003 | Ortho Development Corporation Hip Prosthesis as a component of Primaloc Cemented Hip System. Terminated |
K962448 | |
| Feb 25, 2003 | Ortho Development Corporation Hip Prosthesis as a component of Primaloc Cementless/Collarless Hip System Terminated |
K953977 | |
| Feb 25, 2003 | Ortho Development Corporation Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System. Terminated |
K953977 |