510(k) Report

FDA applicant

Fx Shoulder USA, Inc.

Dallas, TX11 decisions2019–20242 recalls

FDA records 11 decisions for Fx Shoulder USA, Inc. (Dallas, TX) from 2019 to 2024: 11 510(k) clearances. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and PKC (Prosthesis, Total Anatomic Shoulder…). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 4 of them its own earlier devices. 2 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 Fx Shoulder USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12020: 42021: 22022: 22023: 12024: 1
2019high 4 (2020) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2023: 12025: 1
2019high 1 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Fx Shoulder USA, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fx Shoulder USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PHXShoulder Prosthesis, Reverse Configuration9decisions
  • PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No…1decision
  • KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 145 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 143 days; 3 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 23 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 20223cite it
  • K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 20191cites it
  • K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 20201cites it
  • K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc. · 20201cites it
  • K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 20211cites it
  • K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 20231cites it

What has FDA decided for it lately?

  • K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2024
  • K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
  • K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc. · 2022
  • K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
  • K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2021
  • K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc. · 2021
  • K191698TiN Coated Humeral HeadFx Shoulder USA, Inc. · 2020
  • K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc. · 20201 recall

All 11 as Fx Shoulder USA, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K192206Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2…Feb 19, 2025Class II
  • K191146Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210Aug 8, 2023Class II