510(k) Report

FDA applicant

Endius, Inc.

Plainville, MA33 decisions1997–20082 recalls

FDA records 33 decisions for Endius, Inc. (Plainville, MA) from 1997 to 2008: 33 510(k) clearances. Most are in product codes HRX (Arthroscope) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 34 predicates, 23 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 Endius, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2007: 32008: 3
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • HRXArthroscope9decisions
  • NKBThoracolumbosacral Pedicle Screw System7decisions
  • MNIOrthosis, Spinal Pedicle Fixation4decisions
  • KWPAppliance, Fixation, Spinal Interlaminal4decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Also: GWG (1), OCX (1), EOB (1), KWQ (1).

Whose devices does it build on?

Its devices cite 34 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 43 times; 23 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.

  • K991794Endoscopic Spinal Access SystemEndius, Inc. · 19994cite it
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 20074cite it
  • K002437Endius Endoscopic Access SystemEndius, Inc. · 20003cite it
  • K053267Endius Atavi SystemEndius, Inc. · 20063cite it
  • K041808Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 20043cite it
  • K994425Modification to Endoscopic Spinal Access SystemEndius, Inc. · 20003cite it

What has FDA decided for it lately?

  • K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K073510Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2008
  • K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K072840Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007
  • K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  • K061345Modification to Endius Atavi SystemEndius, Inc. · 20061 recall
  • K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006

All 33 as Endius, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K041808Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only…Aug 26, 2013Class II
  • K053267Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or…Feb 8, 2013Class II