510(k) Report

FDA applicant

Orthopro, LLC

Round Rock, TX7 decisions2006–20131 recall

FDA records 7 decisions for Orthopro, LLC (Round Rock, TX) from 2006 to 2013: 7 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and KWD (Prosthesis, Toe, Hemi-, Phalangeal). Its devices cite 13 predicates, 2 of them its own earlier devices. 1 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 Orthopro, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 22008: 12010: 12012: 12013: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Orthopro, 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?

  • HRSPlate, Fixation, Bone2decisions
  • KWDProsthesis, Toe, Hemi-, Phalangeal2decisions
  • HWCScrew, Fixation, Bone2decisions
  • HTYPin, Fixation, Smooth1decision

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 20074cite it
  • K073228DC Ulnar Shortening SystemOrthopro, LLC · 20082cite it
  • K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 20122cite it
  • K062908Orthropro Hemi ToeOrthopro, LLC · 20061cites it
  • K093055CSTS ScrewOrthopro, LLC · 20101cites it
  • K122936Ankle Trauma SystemOrthopro, LLC · 20131cites it

What has FDA decided for it lately?

  • K122936Ankle Trauma SystemOrthopro, LLC · 2013
  • K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
  • K093055CSTS ScrewOrthopro, LLC · 2010
  • K073228DC Ulnar Shortening SystemOrthopro, LLC · 2008
  • K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007
  • K071243Metal Hemi ImplantOrthopro, LLC · 20071 recall
  • K062908Orthropro Hemi ToeOrthopro, LLC · 2006

All 7 as Orthopro, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K071243Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03…May 29, 2008