510(k) Report

FDA applicant

Toby Orthopaedics

Miami, FL2 decisions2008–20131 recall

FDA records 2 decisions for Toby Orthopaedics (Miami, FL) from 2008 to 2013: 2 510(k) clearances. All are in product code HRS (Plate, Fixation, Bone). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Toby Orthopaedics, 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 Toby Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 12013: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2008high 1 (2013) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Toby Orthopaedics by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Toby Orthopaedics’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?

  • HRSPlate, Fixation, Bone2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131834Wolf Long Bone Plate SystemToby Orthopaedics · 2013
  • K081608Proximal Humerus Scaffold Fixation System (Phsfs)Toby Orthopaedics, LLC · 20081 recall

The one decision as Toby Orthopaedics →The one decision as Toby Orthopaedics, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081608PANTERA Proximal Humerus Fracture Plate SystemJun 5, 2013Class II