510(k) Report

FDA applicant

Phygen, LLC

Irvine, CA7 decisions2011–20121 recall

FDA records 7 decisions for Phygen, LLC (Irvine, CA) from 2011 to 2012: 7 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 11 predicates, 3 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 Phygen, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2011: 52012: 2
2011high 5 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Phygen, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Phygen, 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?

  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K110588Leucadia Pedicle Screw SystemPhygen, LLC · 20114cite it
  • K113366Leucadia Autolok Pedicle Screw SystemPhygen, LLC · 20121cites it
  • K103102Leucadia Pedicle Screw SystemPhygen, LLC · 20111cites it
  • K103748Laguna Pedicle Screw SystemPhygen, LLC · 20111cites it

What has FDA decided for it lately?

  • K120355Leucadia 4.5 MM Pedicle Screw SystemPhygen, LLC · 2012
  • K113366Leucadia Autolok Pedicle Screw SystemPhygen, LLC · 20121 recall
  • K112931Leucadia (TM) Mis Pedicle Screw SystemPhygen, LLC · 2011
  • K110679Del Mar Monoaxial Pedicle Screw SystemPhygen, LLC · 2011
  • K110588Leucadia Pedicle Screw SystemPhygen, LLC · 2011
  • K103748Laguna Pedicle Screw SystemPhygen, LLC · 2011
  • K103102Leucadia Pedicle Screw SystemPhygen, LLC · 2011

All 7 as Phygen, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K113366Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction…May 6, 2013Class II