510(k) Report

FDA applicant

New Era Orthopaedics, LLC

Round Rock, TX1 decision2015–20151 recall

FDA records 1 decision for New Era Orthopaedics, LLC (Round Rock, TX) in 2015: 1 510(k) clearance. All are in product code MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 9 predicates, 0 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 New Era Orthopaedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2015high 1 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — New Era Orthopaedics, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New Era Orthopaedics, 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?

  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC · 20151cites it

What has FDA decided for it lately?

  • K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC · 20151 recall

The one decision as New Era Orthopaedics, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141253Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07Feb 13, 2017Class II