510(k) Report

FDA applicant

Additive Implants, Inc.

Phoenix, AZ3 decisions2019–20210 recalls

FDA records 3 decisions for Additive Implants, Inc. (Phoenix, AZ) from 2019 to 2021: 3 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and OVE (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 92 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.

FDA’s records also spell it “Additive Implants, LLC”.

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 Additive Implants, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12020: 12021: 1
2019high 1 (2019) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Additive Implants, Inc. 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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 1 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 9 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.

  • K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 20205cite it
  • K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 20213cite it
  • K182477Cervical SpacerAdditive Implants, LLC · 20191cites it

What has FDA decided for it lately?

  • K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc. · 2021
  • K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
  • K182477Cervical SpacerAdditive Implants, LLC · 2019

All 2 as Additive Implants, Inc. →The one decision as Additive Implants, LLC →

Other applicant names beginning “Additive”

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

Additive Orthopaedics, LLC 7Additive Device, Inc. (Adi) D/B/A Restor3D 2