Company ยท US
Wright Medical Technology Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2023. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
141recalls (1 in 12 months)
117recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 43 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 16 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 12 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 9 |
| HWC | Screw, Fixation, Bone | 9 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 7 |
| LXH | Orthopedic Manual Surgical Instrument | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 5 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 5 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 2 |
| LRO | General Surgery Tray | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 |
| HWR | Driver, Prosthesis | 1 |
| HXX | Screwdriver | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Wright Medical Technology, Inc. CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System Open, Classified |
HRS | K133715 |
| Apr 4, 2024 | Wright Medical Technology, Inc. stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty Open, Classified |
HSN | K123954 |
| Jul 7, 2023 | Wright Medical Technology, Inc. Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. Open, Classified |
HSN | K123954 |
| Apr 26, 2023 | Wright Medical Technology, Inc. stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation Open, Classified |
HRS | K120359 |
| Apr 26, 2023 | Wright Medical Technology, Inc. stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation Open, Classified |
HRS | K120359 |
| Feb 24, 2023 | Wright Medical Technology, Inc. ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device Open, Classified |
HRS | K113014 |
| Feb 24, 2023 | Wright Medical Technology, Inc. ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device Open, Classified |
HRS | K113014 |
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 Terminated |
HSN | K051023 |
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 Terminated |
HSN | K051023 |
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It Open, Classified |
KWI | K060731 K991915 |
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It co Open, Classified |
KWI | K060731 K991915 |
| Jul 27, 2022 | Wright Medical Technology, Inc. Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile. Open, Classified |
MPK | None listed |
| Jun 14, 2022 | Wright Medical Technology, Inc. Wright EVOLVE TRIAD Plate Cutter, REF 49510120 Open, Classified |
QLR | None listed |
| Jun 2, 2022 | Wright Medical Technology, Inc. Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System. Open, Classified |
HSN | K140749 |
| Mar 10, 2022 | Wright Medical Technology, Inc. EasyFuse Dynamic Compression System Instrument Pack Terminated |
JDR | K203832 |
| Feb 15, 2022 | Wright Medical Technology, Inc. Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System. Terminated |
HRS | K090692 |
| Feb 9, 2022 | Wright Medical Technology, Inc. The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The dr Terminated |
HRS | K061808 |
| Dec 3, 2021 | Wright Medical Technology Inc Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. Open, Classified |
HRS | K061808 |
| Dec 3, 2021 | Wright Medical Technology Inc Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. Open, Classified |
HRS | K113014 |
| Dec 3, 2021 | Wright Medical Technology, Inc. Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System. Open, Classified |
HRS | K141417 |
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS Terminated |
HSN | K100886 |
| Nov 4, 2021 | Wright Medical Technology Inc INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS Terminated |
HSN | K100886 |
| Aug 26, 2020 | Wright Medical Technology Inc EVOLVE STEM 8.5MM
Model # 496S085 Terminated |
KWI | K060731 K991915 |
| Jul 28, 2020 | Wright Medical Technology, Inc. Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures Terminated |
LRO | None listed |
| Jul 28, 2020 | Wright Medical Technology, Inc. Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along Terminated |
LRO | None listed |
| Apr 9, 2020 | Wright Medical Technology Inc WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion a Terminated |
HSN | K051023 |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Terminated |
KWI | K060731 |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Terminated |
KWI | K060731 |
| Mar 14, 2018 | Wright Medical Technology, Inc. WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R Terminated |
HSB | K090857 |
| Mar 14, 2018 | Wright Medical Technology, Inc. WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020 Terminated |
HSB | K090857 |
| Nov 8, 2016 | Wright Medical Technology, Inc. CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 Terminated |
HRS | K061808 |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 Terminated |
KYI | K864489 |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON FINGER JOINT #2, Part Number 4700002 Terminated |
KYJ | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON FINGER JOINT #1, Part Number 4700001 Terminated |
KYJ | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 Terminated |
HRS | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 Terminated |
GFF | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S Terminated |
HWC | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 Terminated |
HSB | K090857 |
| Nov 8, 2016 | Wright Medical Technology, Inc. INBONE STEM, TIBIAL, TOP, Part Number 200011901 Terminated |
HSN | K051023 |
| Nov 8, 2016 | Wright Medical Technology, Inc. PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 Terminated |
MBP | K083270 |
| Nov 8, 2016 | Wright Medical Technology, Inc. ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538 Terminated |
HWC | K102429 |
| Nov 8, 2016 | Wright Medical Technology, Inc. SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 Terminated |
KWD | K864492 |
| Sep 1, 2015 | Wright Medical Technology, Inc. CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 1 Terminated |
HRS | K132594 |
| Sep 1, 2015 | Wright Medical Technology, Inc. CrossCHECK Locking Screw in the following sizes:
3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm Terminated |
HRS | K132594 |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| May 18, 2015 | Wright Medical Technology, Inc. PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY Terminated |
HWC | None listed |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1.
Orthopedic use. Terminated |
HRS | K132594 |
| Apr 22, 2015 | Wright Medical Technology, Inc. CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7.
Orthopedic use. Terminated |
HRS | K132594 |
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