Company · US
Wrightmedicaltechnologyinc
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2023. Name variants (Inc, Corp, punctuation) are merged.
302510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 45 |
| HWC | Screw, Fixation, Bone | 31 |
| MQV | Filler, Bone Void, Calcium Compound | 28 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 26 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 12 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 11 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 11 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 8 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 7 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 4 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 4 |
| FMF | Syringe, Piston | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2023 | K222835 | Prophecy Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Jan 5, 2022 | K213342 | PRO-DENSE LoVisc Bone Graft Substitute Wrightmedicaltechnologyinc | MQV |
| Nov 16, 2021 | K212996 | Sterile PHALINX Hammertoe System Wrightmedicaltechnologyinc | HWC |
| Mar 10, 2021 | K202815 | PROPHECY Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Jan 8, 2021 | K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System Wrightmedicaltechnologyinc | HRS |
| Oct 21, 2020 | K200507 | PRO-DENSE LoVisc Bone Graft Substitute Wrightmedicaltechnologyinc | MQV |
| Jun 8, 2020 | K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Aug 22, 2019 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Aug 13, 2019 | K190970 | PROSTEP TBI (Tailors Bunion Implant) System Wrightmedicaltechnologyinc | HWC |
| Jun 6, 2019 | K183620 | PROSTEP TBC Implant System Wrightmedicaltechnologyinc | HRS |
| May 28, 2019 | K190482 | IGNITE Bone Void Filler Wrightmedicaltechnologyinc | MQV |
| May 14, 2019 | K190670 | ORTHOLOC 2 Lapidus with Rotation System Wrightmedicaltechnologyinc | HRS |
| Mar 14, 2019 | K190283 | PROSTIM Injectable Inductive Graft Wrightmedicaltechnologyinc | MQV |
| Mar 13, 2019 | K183026 | Wright Jones Fracture System Wrightmedicaltechnologyinc | HWC |
| Jan 11, 2019 | K181377 | PROSTEP MICA Screw System Wrightmedicaltechnologyinc | HWC |
| Nov 2, 2018 | K182823 | PRODENSE Bone Graft Substitute Wrightmedicaltechnologyinc | MQV |
| Sep 12, 2018 | K181255 | PRODENSE Bone Graft Substitute Wrightmedicaltechnologyinc | MQV |
| Aug 9, 2018 | K181557 | INFINITY Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Jul 11, 2018 | K180730 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Jul 11, 2018 | K180024 | SALVATION Midfoot Nail Wrightmedicaltechnologyinc | HWC |
| Jun 6, 2018 | K180832 | SALVATION External Fixation System Wrightmedicaltechnologyinc | KTT |
| Apr 26, 2018 | K172633 | INFINITY Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Sep 21, 2017 | K171852 | DARCO Locking Bone Plate System Wrightmedicaltechnologyinc | HRS |
| Sep 11, 2017 | K171067 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Aug 22, 2017 | K170642 | GRAVITY Soft Tissue Repair System Wrightmedicaltechnologyinc | GAT |
| Aug 16, 2017 | K170968 | PROPHECY INVISION Pre-operative Navigation System Wrightmedicaltechnologyinc | HSN |
| Jun 30, 2017 | K170249 | GRAVITY Syndesmosis LP Wrightmedicaltechnologyinc | HTN |
| Apr 26, 2017 | K170889 | HV Screw System Wrightmedicaltechnologyinc | HWC |
| Apr 24, 2017 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension Wrightmedicaltechnologyinc | HRS |
| Apr 13, 2017 | K162353 | MICATM Screw System Wrightmedicaltechnologyinc | HWC |
| Mar 13, 2017 | K163039 | ORTHOLOC® 3Di Small Bones Plating Wrightmedicaltechnologyinc | HRS |
| Feb 23, 2017 | K170265 | GRAVITYTM PEEK-OPTIMA Suture Anchor Wrightmedicaltechnologyinc | MBI |
| Feb 22, 2017 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Jan 26, 2017 | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System Wrightmedicaltechnologyinc | HRS |
| May 17, 2016 | K152062 | BIOFOAM Bone Wedge Wrightmedicaltechnologyinc | HRS |
| May 6, 2016 | K153008 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Jan 13, 2016 | K153635 | SALVATION(R) External Fixation System Wrightmedicaltechnologyinc | KTT |
| Dec 11, 2015 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System Wrightmedicaltechnologyinc | HRS |
| Dec 1, 2015 | K150640 | RX-FIX Mini Rail External Fixator Wrightmedicaltechnologyinc | KTT |
| Sep 4, 2015 | K151838 | PRO-TOE Hammertoe Fixation System Wrightmedicaltechnologyinc | HWC |
| Sep 4, 2015 | K151442 | TOTAL COMPRESSION PLATING (TCP) SYSTEM Wrightmedicaltechnologyinc | HRS |
| Aug 21, 2015 | K152045 | SALVATION® External Fixation System Wrightmedicaltechnologyinc | KTT |
| May 20, 2015 | K142724 | BIOFOAM Bone Wedge Wrightmedicaltechnologyinc | HRS |
| May 8, 2015 | K150213 | Subtalar Spacer System (STS) Wrightmedicaltechnologyinc | HWC |
| Apr 29, 2015 | K150520 | DARCO Locking Bone Plate System Wrightmedicaltechnologyinc | HRS |
| Apr 29, 2015 | K150252 | PHALINX Hammertoe System Wrightmedicaltechnologyinc | HWC |
| Mar 25, 2015 | K142117 | INVISION TOTAL ANKLE REVISION SYSTEM Wrightmedicaltechnologyinc | HSN |
| Mar 5, 2015 | K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc | HSN |
| Mar 4, 2015 | K150004 | SALVATION External Fixation System Wrightmedicaltechnologyinc | KTT |
| Feb 10, 2015 | K150073 | MICRONAIL Distal Radius System Wrightmedicaltechnologyinc | HSB |
Newest 50 of 302.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||