510(k) Report

FDA applicant

Axis Orthopaedics

Soldotna, AK3 decisions2018–20180 recalls

FDA records 3 decisions for Axis Orthopaedics (Soldotna, AK) in 2018: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 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 Axis Orthopaedics’s devices, and how often a recall has named them.

FDA decisions per year

3in 2018

2018: 3
2018high 3 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Axis Orthopaedics by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Axis Orthopaedics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 106 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 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.

  • K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics · 20182cite it
  • K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics · 20181cites it

What has FDA decided for it lately?

  • K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics · 2018
  • K180301AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics · 2018
  • K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018

All 3 as Axis Orthopaedics →

Other applicant names beginning “Axis”

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

Axis-Shield Diagnostics, Ltd. 28Axis-Shield Poc AS 4Axis-Shield, Ltd. 3Axis Biochemicals, Asa 3Axis-Shield Biochemicals, Asa 2Axis Spine Technologies, Ltd. 2Axis-Shield Doc AS 1Axis Surgical Technologies, Inc. 1Axis 1Axis Health Care, LLC 1