510(k) Report

FDA applicant

New Era Orthopedics, LLC

Hummelstown, PA2 decisions2014–20151 recall

FDA records 2 decisions for New Era Orthopedics, LLC (Hummelstown, PA) from 2014 to 2015: 2 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 5 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 Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2014high 1 (2017) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — New Era Orthopedics, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNIOrthosis, Spinal Pedicle Fixation1decision
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC · 20151 recall
  • K142388Neo Total Knee SystemNew Era Orthopedics, LLC · 2014

All 2 as New Era Orthopedics, 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