510(k) Report

FDA applicant

Instratek, Inc.

Houston, TX10 decisions1992–201416 recalls

FDA records 10 decisions for Instratek, Inc. (Houston, TX) from 1992 to 2014: 10 510(k) clearances. Most are in product codes HRX (Arthroscope) and HTN (Washer, Bolt Nut). Its devices cite 24 predicates, 2 of them its own earlier devices. 16 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 Instratek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 22009: 12011: 12012: 12013: 12014: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

15in 2019

2013: 12019: 15
2007high 15 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Instratek, 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?

  • HRXArthroscope3decisions
  • HTNWasher, Bolt Nut3decisions
  • HWCScrew, Fixation, Bone3decisions
  • JDRStaple, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 24 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 17 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.

  • K080280Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 20085cite it
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20124cite it
  • K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc. · 20092cite it
  • K925083Endotrak SystemInstratek, Inc. · 19931cites it
  • K111032CMC Cable FixInstratek, Inc. · 20111cites it
  • K922391Endoscopic Carpal Tunnel InstrumentsInstratek, Inc. · 19921cites it

What has FDA decided for it lately?

  • K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
  • K131620Jones-FX Fracture SystemInstratek, Inc. · 2013
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K111032CMC Cable FixInstratek, Inc. · 2011
  • K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc. · 2009
  • K082384Hav-Lok Bunion Correction SystemInstratek, Inc. · 2008
  • K080280Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008
  • K940230Endoscopic Mortons Neuroma InstrumentsInstratek, Inc. · 199413 recalls

All 10 as Instratek, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K940230Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for…Jul 25, 2019Class II
  • K940230Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed…Jul 25, 2019Class II
  • K940230Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the…Jul 25, 2019Class II
  • K940230Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the…Jul 25, 2019Class II
  • K940230Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the…Jul 25, 2019Class II
  • K940230Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the…Jul 25, 2019Class II