510(k) Report

FDA applicant

Restor3D

Durham, NC20 decisions2020–20263 recalls

FDA records 20 decisions for Restor3D (Durham, NC) from 2020 to 2026: 20 510(k) clearances. Most are in product codes HSN (Prosthesis, Ankle, Semi-Constrained, Cemented…) and PHX (Shoulder Prosthesis, Reverse Configuration). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Restor3D, Inc.”, “restor3d, inc.”.

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 Restor3D’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2020: 12021: 12022: 32023: 32024: 42025: 52026 (partial year): 3
2020high 5 (2025) · low 1 (2020)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026 (partial year): 3
2020high 3 (2026) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Restor3D by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer5decisions
  • PHXShoulder Prosthesis, Reverse Configuration4decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • OYKAnkle Arthroplasty Implantation System1decision
  • PLFBone Wedge1decision
  • SAIAnkle Fusion Cage1decision

Also: LPH (1), HTY (1), KWD (1), HWC (1), MBH (1), JDR (1).

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 94 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 7 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 6 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.

  • K201314Restor3d Utility WedgeRestor3D, Inc. · 20214cite it
  • K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 20222cite it
  • K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D · 20251cites it
  • K232595Kinos Axiom Total Ankle SystemRestor3D · 20231cites it
  • K241482Kinos Total Ankle SystemRestor3D · 20241cites it
  • K242868Kinos Total Ankle SystemRestor3D · 20241cites it

What has FDA decided for it lately?

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K253992Veritas Reverse Total Shoulder SystemRestor3D · 2026
  • K252067Velora Acetabular SystemRestor3D, Inc. · 2025
  • K252454Kinos Total Ankle SystemRestor3D · 2025
  • K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D · 20251 recall
  • K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc. · 2025
  • K242356TIDAL Fusion Cage SystemRestor3D, Inc. · 2025

All 13 as Restor3D →All 6 as Restor3D, Inc. →The one decision as restor3d, inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K201393Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number…Sep 4, 2026Class II
  • K223326Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006Jul 27, 2026Class II
  • K243643Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…Jun 30, 2026Class II