510(k) Report

FDA applicant

Ortho Solutions Limited

Prior Lake, MN6 decisions2011–20144 recalls

FDA records 6 decisions for Ortho Solutions Limited (Prior Lake, MN) from 2011 to 2014: 6 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWE (Instrument, Surgical, Orthopedic, Ac-Powered…). Its devices cite 58 predicates, 1 of them its own earlier devices. 4 recalls are 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 Ortho Solutions Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 22012: 32014: 1
2011high 3 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2025

2015: 12016: 12017: 12025: 1
2011high 1 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ortho Solutions Limited by year, 2011–2026Sources: 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, Bone3decisions
  • HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1decision
  • HWCScrew, Fixation, Bone1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision

Whose devices does it build on?

Its devices cite 58 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 18 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.

  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20128cite it
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 20144cite it
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 20113cite it
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 20122cite it
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121cites it

What has FDA decided for it lately?

  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 20142 recalls
  • K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited · 20121 recall
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011

All 6 as Ortho Solutions Limited →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K141784Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401…Sep 17, 2025Class II
  • K121575Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular…Apr 19, 2017Class II
  • K111678FPS 35mm x 3.5 mm non-locking screwJul 21, 2016Class II
  • K141784Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5…Jul 14, 2015Class II

Other applicant names beginning “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152Ortho Diagnostic Systems, Inc. 126Ortho Development Corp. 64Ortho Diagnostics, Inc. 24Ortho Tec, LLC 22Ortho Pharmaceutical Corp. 9Ortho Source 9Ortho Organizers, Inc. 8Ortho Kinetics Corp. 7Ortho Instruments 6Ortho Kinematics, Inc. 6Ortho Solutions UK, Ltd. 5