510(k) Report

FDA applicant

Auxein Medical Private Limited

Sonipat, IN12 decisions2020–20230 recalls

FDA records 12 decisions for Auxein Medical Private Limited (Sonipat, IN) from 2020 to 2023: 12 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 355 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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 Auxein Medical Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 12021: 22022: 72023: 2
2020high 7 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Auxein Medical Private Limited by year, 2020–2026Sources: 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, Bone4decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue4decisions
  • HWCScrew, Fixation, Bone2decisions
  • JDSNail, Fixation, Bone1decision
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 355 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 0 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K213059Tibia and Fibula SystemAuxein Medical Private Limited · 20232cite it
  • K192003Auxein Nailing SystemAuxein Medical Private Limited · 20202cite it
  • K213108Humerus & Ulna SystemAuxein Medical Private Limited · 20221cites it

What has FDA decided for it lately?

  • K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
  • K213059Tibia and Fibula SystemAuxein Medical Private Limited · 2023
  • K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited · 2022
  • K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited · 2022
  • K213108Humerus & Ulna SystemAuxein Medical Private Limited · 2022
  • K213014Varixis Elbow SystemAuxein Medical Private Limited · 2022
  • K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited · 2022
  • K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited · 2022

All 12 as Auxein Medical Private Limited →

Other applicant names beginning “Auxein”

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

Auxein Medical Private Limited/71164 1Auxein Medical 1Auxein Medical Pvt., Ltd. 1