510(k) Report

FDA applicant

Mx Orthopedics, Corp.

Lexington, MA4 decisions2015–20170 recalls

FDA records 4 decisions for Mx Orthopedics, Corp. (Lexington, MA) from 2015 to 2017: 4 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 1 of them its own earlier devices. No 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 Mx Orthopedics, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2015: 12016: 22017: 1
2015high 2 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Mx Orthopedics, Corp. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JDRStaple, Fixation, Bone2decisions
  • HWCScrew, Fixation, Bone1decision
  • HRSPlate, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K160427dynaMX (TM) Nitinol Compression ScrewMx Orthopedics, Corp. · 20162cite it
  • K143622dynaMX Compression StapleMx Orthopedics, Corp. · 20151cites it
  • K153129dynaMX Tabbed StapleMx Orthopedics, Corp. · 20161cites it
  • K161303dynaMX™ Compression PlateMx Orthopedics, Corp. · 20171cites it

What has FDA decided for it lately?

  • K161303dynaMX™ Compression PlateMx Orthopedics, Corp. · 2017
  • K160427dynaMX (TM) Nitinol Compression ScrewMx Orthopedics, Corp. · 2016
  • K153129dynaMX Tabbed StapleMx Orthopedics, Corp. · 2016
  • K143622dynaMX Compression StapleMx Orthopedics, Corp. · 2015

All 4 as Mx Orthopedics, Corp. →