510(k) Report

FDA applicant

Gold Standard Orthopaedics, LLC

Louisville, KY4 decisions2007–20130 recalls

FDA records 4 decisions for Gold Standard Orthopaedics, LLC (Louisville, KY) from 2007 to 2013: 4 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and HWC (Screw, Fixation, Bone). Its devices cite 15 predicates, 2 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 Gold Standard Orthopaedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22009: 12013: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gold Standard Orthopaedics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gold Standard Orthopaedics, LLC’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?

  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • HWCScrew, Fixation, Bone1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K070966Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC · 20072cite it
  • K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 20071cites it

What has FDA decided for it lately?

  • K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC · 2013
  • K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009
  • K070966Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC · 2007
  • K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007

All 4 as Gold Standard Orthopaedics, LLC →

Other applicant names beginning “Gold”

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

Gold Standard Diagnostics 15Gold Standard Orthopedics, LLC 2Gold Coast Imaging, Inc. 2Gold, Inc. 1Gold Cadillac Co. 1Gold Link Design, Ltd. 1Gold'N Braces, Inc. 1