Nextremity Solutions
FDA Regulatory Profile
Nextremity Solutions appears in FDA public data with 15 recalls, 20 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0913-2022, Class II) was initiated on February 10, 2022. Its most recent 510(k) clearance was granted on November 4, 2022.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0913-2022 | Class II | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthope | February 10, 2022 |
| Z-0910-2022 | Class II | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgica | February 10, 2022 |
| Z-0914-2022 | Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument | February 10, 2022 |
| Z-0911-2022 | Class II | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthop | February 10, 2022 |
| Z-0912-2022 | Class II | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical | February 10, 2022 |
| Z-0739-2022 | Class II | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited t | January 13, 2022 |
| Z-0740-2022 | Class II | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited | January 13, 2022 |
| Z-1501-2021 | Class II | InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a thr | March 26, 2021 |
| Z-1500-2021 | Class II | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a thre | March 26, 2021 |
| Z-1458-2020 | Class II | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Produ | February 12, 2020 |
| Z-1127-2020 | Class II | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of | December 16, 2019 |
| Z-0776-2020 | Class II | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | November 11, 2019 |
| Z-0778-2020 | Class II | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST | November 11, 2019 |
| Z-0777-2020 | Class II | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST | November 11, 2019 |
| Z-0534-2020 | Class II | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Prod | October 9, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221610 | Nextra CH Cannulated Hammertoe System | November 4, 2022 |
| K212979 | CalcShift Displacement Calcaneal Osteotomy System | May 20, 2022 |
| K220181 | StealthFix Intraosseous Fixation System | March 22, 2022 |
| K213301 | InCore Subtalar System | December 21, 2021 |
| K213530 | Nextra CH Cannulated Hammertoe System | December 9, 2021 |
| K212640 | Stratum® Ankle Fusion Plating System | November 18, 2021 |
| K211996 | Nexta PEEK Hammertoe Correction System | September 23, 2021 |
| K200785 | Stratum Reduced Size Foot Plating System | July 27, 2020 |
| K200840 | DuoHex CH Cannulated Hammertoe System | June 26, 2020 |
| K200124 | InCore MPJ System | May 13, 2020 |
| K192578 | InCore TMT System | December 31, 2019 |
| K190231 | InCore® Lapidus Sterile Kits | May 24, 2019 |
| K182201 | Stratum Foot Plating System | November 16, 2018 |
| K180257 | InCore® Lapidus System | April 25, 2018 |
| K152548 | AXI+LINE Proximal Bunion Correction System | December 21, 2015 |
| K151160 | Arcus Staple System | September 4, 2015 |
| K140724 | MSP METATARSAL SHORTENING SYSTEM | May 14, 2014 |
| K131061 | RESTORE BUNION CORRECTION SYSTEM | August 28, 2013 |
| K122031 | NEXTRA TI HAMMERTOE CORRECTION SYSTEM | October 9, 2012 |
| K110445 | FLEXFUSION (TM) FIXATION IMPLANT | March 17, 2011 |