Nextremity Solutions

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0910-2022Class IINextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgicaFebruary 10, 2022
Z-0914-2022Class IINextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrumentFebruary 10, 2022
Z-0912-2022Class IINextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgicalFebruary 10, 2022
Z-0913-2022Class IINextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC OrthopeFebruary 10, 2022
Z-0911-2022Class IINextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC OrthopFebruary 10, 2022
Z-0739-2022Class IINextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited tJanuary 13, 2022
Z-0740-2022Class IINextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited January 13, 2022
Z-1500-2021Class IIInCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a threMarch 26, 2021
Z-1501-2021Class IIInCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a thrMarch 26, 2021
Z-1458-2020Class IINextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - ProduFebruary 12, 2020
Z-1127-2020Class IIStratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of December 16, 2019
Z-0778-2020Class IIStratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550STNovember 11, 2019
Z-0777-2020Class IIStratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548STNovember 11, 2019
Z-0776-2020Class IIStratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546STNovember 11, 2019
Z-0534-2020Class IIStratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - ProdOctober 9, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K221610Nextra CH Cannulated Hammertoe SystemNovember 4, 2022
K212979CalcShift™ Displacement Calcaneal Osteotomy SystemMay 20, 2022
K220181StealthFix Intraosseous Fixation SystemMarch 22, 2022
K213301InCore Subtalar SystemDecember 21, 2021
K213530Nextra CH Cannulated Hammertoe SystemDecember 9, 2021
K212640Stratum® Ankle Fusion Plating SystemNovember 18, 2021
K211996Nexta PEEK Hammertoe Correction SystemSeptember 23, 2021
K200785Stratum™ Reduced Size Foot Plating SystemJuly 27, 2020
K200840DuoHex CH Cannulated Hammertoe SystemJune 26, 2020
K200124InCore MPJ SystemMay 13, 2020
K192578InCore TMT SystemDecember 31, 2019
K190231InCore® Lapidus Sterile KitsMay 24, 2019
K182201Stratum™ Foot Plating SystemNovember 16, 2018
K180257InCore® Lapidus SystemApril 25, 2018
K152548AXI+LINE Proximal Bunion Correction SystemDecember 21, 2015
K151160Arcus Staple SystemSeptember 4, 2015
K140724MSP METATARSAL SHORTENING SYSTEMMay 14, 2014
K131061RESTORE BUNION CORRECTION SYSTEMAugust 28, 2013
K122031NEXTRA TI HAMMERTOE CORRECTION SYSTEMOctober 9, 2012
K110445FLEXFUSION (TM) FIXATION IMPLANTMarch 17, 2011