510(k) Report

FDA applicant

Matrix Surgical USA

Alpharetta, GA1 decision2013–20133 recalls

FDA records 1 decision for Matrix Surgical USA (Alpharetta, GA) in 2013: 1 510(k) clearance. All are in product code KKY (Material, Polytetrafluoroethylene Vitreous…). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Matrix Surgical USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2019

2017: 12019: 2
2013high 2 (2019) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Matrix Surgical USA by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K123908Omnipore Surgical Implants and AccessoriesMatrix Surgical USA · 20133cite it

What has FDA decided for it lately?

  • K123908Omnipore Surgical Implants and AccessoriesMatrix Surgical USA · 20133 recalls

The one decision as Matrix Surgical USA →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K123908OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical…Jan 30, 2019Class II
  • K123908OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical…Jan 30, 2019Class II
  • K123908OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay -…Jan 25, 2017Class II

Other applicant names beginning “Matrix”

FDA records each applicant name separately; these may or may not be the same firm.

Matrix Medica, Inc. 14Matrix Instruments 4Matrix Technologies Corp. 3Matrix Electromedical, Inc. 2Matrix Surgical Holdings, LLC/Matrix Surgical USA 2Matrix Biokinetics, Inc. 1Matrix Intl. 1