510(k) Report

FDA applicant

In2bones USA, LLC

Memphis, TN27 decisions2016–20265 recalls

FDA records 27 decisions for In2bones USA, LLC (Memphis, TN) from 2016 to 2026: 27 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 96 predicates, 48 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “In2bones USA”, “In2Bones USA, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided In2bones USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2016: 22017: 32018: 42019: 22020: 52021: 52022: 22023: 12024: 22026 (partial year): 1
2016high 5 (2020) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

2in 2026

2018: 32026 (partial year): 2
2016high 3 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — In2bones USA, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRSPlate, Fixation, Bone16decisions
  • HWCScrew, Fixation, Bone3decisions
  • KWHProsthesis, Toe, Constrained, Polymer2decisions
  • KWIProsthesis, Elbow, Hemi-, Radial, Polymer2decisions
  • JDRStaple, Fixation, Bone1decision
  • HTYPin, Fixation, Smooth1decision

Also: MBI (1), HTN (1).

How long do its 510(k) reviews take?

Since 2016, its 23 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 14 of its 23 were faster than that.

Whose devices does it build on?

Its devices cite 96 predicates; 48 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 56 times; 48 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163293Colink™ Plating SystemIn2bones USA, LLC · 201714cite it
  • K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 20189cite it
  • K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 20176cite it
  • K180377Fracture and Correction SystemIn2bones USA, LLC · 20185cite it
  • K172300CoLink View Plating SystemIn2bones USA, LLC · 20175cite it
  • K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 20162cite it

What has FDA decided for it lately?

  • K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC · 2026
  • K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA · 2024
  • K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC · 2024
  • K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC · 2023
  • K213698CoLink PCR Plating SystemIn2bones USA, LLC · 2022
  • K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC · 2022
  • K212872Avenger Radial Head SystemIn2bones USA, LLC · 2021
  • K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC · 2021

All 25 as In2bones USA, LLC →The one decision as In2bones USA →The one decision as In2Bones USA, LLC →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K170518REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmSep 9, 2026Class II
  • K161426NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name…May 11, 2026Class II
  • K161426NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50…Nov 14, 2018Class II
  • K163293CoLink (TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage…Jul 16, 2018Class II
  • K163293CoLink (TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product…Jul 16, 2018Class II

Other applicant names beginning “In2bones”

FDA records each applicant name separately; these may or may not be the same firm.

In2bones Sas 18