Chrysalis Intelligence · Sponsors · Nextremity Solutions, Inc.

Nextremity Solutions, Inc.

Warsaw, IN, US · 10 510(k) clearances · 10 recalls

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Total clearances
10
2020-05-13 → 2022-11-04
Last 12 months
0
Product codes
3
Most recent
2022-11-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HWC Screw, Fixation, Bone Class II Orthopedic 6 2022-11-04
HRS Plate, Fixation, Bone Class II Orthopedic 3 2022-05-20
JDR Staple, Fixation, Bone Class II Orthopedic 1 2022-03-22
Safety

Recalls (10)

Class I (serious)
0
Risk of injury / death
Total recalls
10
Currently ongoing
0
Most recent
2022-02-10
DateSeverityStatusRecall # ProductCodeReason
2022-02-10 Class II Terminated Z-0914-2022 Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument — Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay…
2022-02-10 Class II Terminated Z-0913-2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrum… — Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay…
2022-02-10 Class II Terminated Z-0912-2022 Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument — Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay…
2022-02-10 Class II Terminated Z-0911-2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instru… — Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay…
2022-02-10 Class II Terminated Z-0910-2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument — Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay…
2022-01-13 Class II Terminated Z-0740-2022 Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital rep… — During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the …
2022-01-13 Class II Terminated Z-0739-2022 Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repa… — During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the …
2021-03-26 Class II Terminated Z-1501-2021 InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct in… — Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bu…
2021-03-26 Class II Terminated Z-1500-2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct int… — Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bu…
2020-02-12 Class II Terminated Z-1458-2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra… — Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the pro…
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2022-11-04 K221610 Nextra CH Cannulated Hammertoe System HWC Class II Orthopedic
2022-05-20 K212979 CalcShift™ Displacement Calcaneal Osteotomy System HRS Class II Orthopedic
2022-03-22 K220181 StealthFix Intraosseous Fixation System JDR Class II Orthopedic
2021-12-21 K213301 InCore Subtalar System HWC Class II Orthopedic
2021-12-09 K213530 Nextra CH Cannulated Hammertoe System HWC Class II Orthopedic
2021-11-18 K212640 Stratum® Ankle Fusion Plating System HRS Class II Orthopedic
2021-09-23 K211996 Nexta PEEK Hammertoe Correction System HWC Class II Orthopedic
2020-07-27 K200785 Stratum™ Reduced Size Foot Plating System HRS Class II Orthopedic
2020-06-26 K200840 DuoHex CH Cannulated Hammertoe System HWC Class II Orthopedic
2020-05-13 K200124 InCore MPJ System HWC Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence