510(k) Report

FDA applicant

Astura Medical

Carlsbad, CA29 decisions2016–20260 recalls

FDA records 29 decisions for Astura Medical (Carlsbad, CA) from 2016 to 2026: 29 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 139 predicates, 44 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Astura Medical, 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 Astura Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 42017: 22018: 52019: 32020: 32021: 12022: 12023: 52024: 22025: 22026 (partial year): 1
2016high 5 (2018) · low 1 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Astura Medical by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Astura Medical’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar7decisions
  • NKBThoracolumbosacral Pedicle Screw System5decisions
  • OLOOrthopedic Stereotaxic Instrument3decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • PLRSpinal Vertebral Body Replacement Device - Cervical1decision

Also: KWQ (1), OWI (1), MQP (1), OUR (1), PML (1), NKG (1).

How long do its 510(k) reviews take?

Since 2016, its 26 510(k)s took a median of 149 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 102 days; 6 of its 26 were faster than that.

Whose devices does it build on?

Its devices cite 139 predicates; 44 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 71 times; 44 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.

  • K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical · 20168cite it
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 20197cite it
  • K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 20176cite it
  • K160154ALTA Anterior Cervical Interbody SpacerAstura Medical · 20165cite it
  • K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 20184cite it
  • K173324ALTA Anterior Cervical Interbody SpacerAstura Medical · 20184cite it

What has FDA decided for it lately?

  • K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2026
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K240160EGPS Navigated InstrumentsAstura Medical · 2024
  • K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024
  • K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023
  • K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical · 2023
  • K223335SIRION Lateral Lumbar Interbody SystemAstura Medical · 2023

All 21 as Astura Medical →All 8 as Astura Medical, LLC →