510(k) Report

FDA applicant

New Standard Device Dba Metalogix

San Antonio, TX2 decisions2019–20245 recalls

FDA records 2 decisions for New Standard Device Dba Metalogix (San Antonio, TX) from 2019 to 2024: 2 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 8 predicates, 1 of them its own earlier devices. 5 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 New Standard Device Dba Metalogix’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12024: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

2in 2020

2019: 32020: 2
2019high 3 (2019) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — New Standard Device Dba Metalogix by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 20191cites it

What has FDA decided for it lately?

  • K233025Revolution External Plating SystemNew Standard Device Dba Metalogix · 2024
  • K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 20195 recalls

All 2 as New Standard Device Dba Metalogix →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K181630Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System.…Dec 28, 2020Class II
  • K1816301.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating SystemJun 8, 2020Class II
  • K181630Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636…Oct 10, 2019Class II
  • K181630Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618AAug 14, 2019Class II
  • K181630'n'-Hole Post which is a component of the Revolution External Fixation System Catalog…Jul 23, 2019Class II