510(k) Report

FDA applicant

Osseus Fusion Systems, LLC

Dallas, TX10 decisions2013–20230 recalls

FDA records 10 decisions for Osseus Fusion Systems, LLC (Dallas, TX) from 2013 to 2023: 10 510(k) clearances. Most are in product codes OVD (Intervertebral Fusion Device With Integrated…) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 64 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Osseus Fusion Systems”.

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 Osseus Fusion Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12016: 12017: 12018: 12019: 12020: 12022: 32023: 1
2013high 3 (2022) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Osseus Fusion Systems, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osseus Fusion Systems, 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?

  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • OURSacroiliac Joint Fixation1decision
  • NKGPosterior Cervical Screw System1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Also: NKB (1), OLO (1), KWQ (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 104 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 3 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 64 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 4 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.

  • K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 20224cite it
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 20183cite it
  • K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 20221cites it
  • K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 20231cites it
  • K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC · 20131cites it
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 20191cites it

What has FDA decided for it lately?

  • K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023
  • K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022
  • K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
  • K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
  • K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems · 2020
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017

All 5 as Osseus Fusion Systems, LLC →All 5 as Osseus Fusion Systems →

Other applicant names beginning “Osseus”

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

Osseus, LLC 2Osseus Fusions Systems, LLC 1