Chrysalis Intelligence · Sponsors · In2bones USA, LLC

In2bones USA, LLC

Memphis, TN, US · 16 510(k) clearances · 2 recalls

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Total clearances
16
2020-01-07 → 2026-05-30
Last 12 months
1
Product codes
6
Most recent
2026-05-30
Name variants in FDA filings: In2Bones USA, LLC / In2bones USA, LLC / In2bones USA
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 9 2024-08-13
HWC Screw, Fixation, Bone Class II Orthopedic 2 2026-05-30
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Class II Orthopedic 2 2021-12-17
HTN Washer, Bolt Nut Class II Orthopedic 1 2022-03-31
HTY — — — 1 2021-05-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 1 2020-08-20
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
1
Most recent
2026-05-11
DateSeverityStatusRecall # ProductCodeReason
2026-05-11 Class II Ongoing Z-2355-2026 NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElasti… — Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
2021-08-18 Class II Terminated Z-2506-2021 CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended f… — Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Filings

All 510(k) clearances (16)

Date K-number Device Code Class Specialty
2026-05-30 K261154 CoLink® & CoLag® Non-Sterile Screws HWC Class II Orthopedic
2024-08-13 K241387 CoLink NeoFuse MIS Plating System (see attached parts list) HRS Class II Orthopedic
2024-05-24 K233089 NeoSpan® Compression Implant System HRS Class II Orthopedic
2023-07-27 K231236 IBS-B MIS Beveled Screw System HWC Class II Orthopedic
2022-05-27 K213698 CoLink PCR Plating System HRS Class II Orthopedic
2022-03-31 K220260 Hercules Syndesmosis Implant System HTN Class II Orthopedic
2021-12-17 K212872 Avenger Radial Head System KWI Class II Orthopedic
2021-12-13 K213069 CoLink NeoFuse Plating System HRS Class II Orthopedic
2021-11-18 K212487 CoLink Vallux Plating System HRS Class II Orthopedic
2021-05-04 K203698 CoLink Sfx Implant System HTY — —
2021-03-12 K210060 CoLink Mfx Implant System HRS Class II Orthopedic
2020-08-20 K201636 Hercules Suture Anchor System MBI Class II Orthopedic
2020-07-15 K201149 CoLink Plating System HRS Class II Orthopedic
2020-04-23 K200762 CoLink Cfx Plating System HRS Class II Orthopedic
2020-01-17 K193543 CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System HRS Class II Orthopedic
2020-01-07 K192754 Avenger Radial Head System KWI Class II Orthopedic
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence