Nextremity Solutions, Inc.
Medical device manufacturer in Warsaw, IN.
20510(k) clearances
0PMA approvals
15recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221610 | Nextra CH Cannulated Hammertoe SystemHWC · Traditional | 11/04/2022SE |
| K212979 | CalcShift Displacement Calcaneal Osteotomy SystemHRS · Traditional | 05/20/2022SE |
| K220181 | StealthFix Intraosseous Fixation SystemJDR · Traditional | 03/22/2022SE |
| K213301 | InCore Subtalar SystemHWC · Traditional | 12/21/2021SE |
| K213530 | Nextra CH Cannulated Hammertoe SystemHWC · Special | 12/09/2021SE |
| K212640 | Stratum® Ankle Fusion Plating SystemHRS · Traditional | 11/18/2021SE |
| K211996 | Nexta PEEK Hammertoe Correction SystemHWC · Traditional | 09/23/2021SE |
| K200785 | Stratum Reduced Size Foot Plating SystemHRS · Traditional | 07/27/2020SE |
| K200840 | DuoHex CH Cannulated Hammertoe SystemHWC · Traditional | 06/26/2020SE |
| K200124 | InCore MPJ SystemHWC · Traditional | 05/13/2020SE |
| K192578 | InCore TMT SystemHWC · Traditional | 12/31/2019SE |
| K190231 | InCore® Lapidus Sterile KitsHWC · Traditional | 05/24/2019SE |
| K182201 | Stratum Foot Plating SystemHRS · Traditional | 11/16/2018SE |
| K180257 | InCore® Lapidus SystemHWC · Traditional | 04/25/2018SE |
| K152548 | AXI+LINE Proximal Bunion Correction SystemHRS · Traditional | 12/21/2015SE |
| K151160 | Arcus Staple SystemJDR · Traditional | 09/04/2015SE |
| K140724 | MSP Metatarsal Shortening SystemHRS · Traditional | 05/14/2014SE |
| K131061 | Restore Bunion Correction SystemJDR · Traditional | 08/28/2013SE |
| K122031 | Nextra Ti Hammertoe Correction SystemHWC · Traditional | 10/09/2012SE |
| K110445 | Flexfusion (TM) Fixation ImplantHWC · Traditional | 03/17/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0914-2022 Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrumentProximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0913-2022 Class II | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0912-2022 Class II | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0911-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0910-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0740-2022 Class II | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone…During insertion of the middle phalanx implant into bone, the driver may deform the implant locking… | 01/13/2022Terminated |
| Z-0739-2022 Class II | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone…During insertion of the middle phalanx implant into bone, the driver may deform the implant locking… | 01/13/2022Terminated |
| Z-1501-2021 Class II | InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage:…Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not… | 03/26/2021Terminated |
| Z-1500-2021 Class II | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage:…Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not… | 03/26/2021Terminated |
| Z-1458-2020 Class II | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF:…Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making… | 02/12/2020Terminated |
| Z-1127-2020 Class II | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product…The product contains a different plate than indicated by the package labeling. The product is labeled as a… | 12/16/2019Terminated |
| Z-0778-2020 Class II | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550STComponents 2mm shorter than indicated on the package label | 11/11/2019Terminated |
| Z-0777-2020 Class II | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548STComponents 2mm shorter than indicated on the package label | 11/11/2019Terminated |
| Z-0776-2020 Class II | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546STComponents 2mm shorter than indicated on the package label | 11/11/2019Terminated |
| Z-0534-2020 Class II | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number:…Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type… | 10/09/2019Terminated |