Ortho Development Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 14
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1904-2020 | Class II | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. | May 30, 2019 |
| Z-1903-2020 | Class II | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | May 30, 2019 |
| Z-2256-2014 | Class II | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA | July 11, 2014 |
| Z-2257-2014 | Class II | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used | July 11, 2014 |
| Z-2253-2014 | Class II | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty proce | July 11, 2014 |
| Z-2254-2014 | Class II | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface | July 11, 2014 |
| Z-2255-2014 | Class II | PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve a | July 11, 2014 |
| Z-1610-2014 | Class II | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Bal | April 1, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | October 25, 2023 |
| K211086 | The Progen Trochanteric Nail System | December 21, 2021 |
| K211471 | Balanced Knee System Uni | December 16, 2021 |
| K203023 | Pisces Spinal System | July 14, 2021 |
| K200281 | The Gecko Spinal System | March 31, 2020 |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | October 31, 2018 |
| K181569 | BKS Revision Sleeves System | October 12, 2018 |
| K180743 | Balanced Knee Revision System - Offset Junction Box | June 20, 2018 |
| K173951 | Legend Acetabular Liners | May 30, 2018 |
| K171249 | Entrada hip stem | August 24, 2017 |
| K162995 | Ibis® Pedicle Screw System | March 30, 2017 |
| K161080 | Escalade Legend Acetabular Shell | May 17, 2016 |
| K153216 | Alpine Cemented Hip System | February 18, 2016 |
| K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts | October 27, 2015 |