510(k) Report

FDA applicant

Hd Lifesciences, LLC

Stoneham, MA3 decisions2017–20200 recalls

FDA records 3 decisions for Hd Lifesciences, LLC (Stoneham, MA) from 2017 to 2020: 3 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 2 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 Hd Lifesciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12018: 12020: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Hd Lifesciences, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hd Lifesciences, LLC’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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K170676HD Lumbar Interbody SystemHd Lifesciences, LLC · 20177cite it
  • K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 20183cite it
  • K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 20201cites it

What has FDA decided for it lately?

  • K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC · 2020
  • K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
  • K170676HD Lumbar Interbody SystemHd Lifesciences, LLC · 2017

All 3 as Hd Lifesciences, LLC →