510(k) Report

FDA applicant

Ht Medical D.B.A. Xenix Medical

Orlando, FL4 decisions2023–20250 recalls

FDA records 4 decisions for Ht Medical D.B.A. Xenix Medical (Orlando, FL) from 2023 to 2025: 4 510(k) clearances. Most are in product codes OUR (Sacroiliac Joint Fixation) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ht Medical, LLC Dba Xenix Medical”.

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 Ht Medical D.B.A. Xenix Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 32025: 1
2023high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Ht Medical D.B.A. Xenix Medical by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • OURSacroiliac Joint Fixation2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 58 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 20232cite it
  • K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 20231cites it
  • K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 20251cites it
  • K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical · 20231cites it

What has FDA decided for it lately?

  • K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025
  • K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical · 2023
  • K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 2023
  • K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023

All 3 as Ht Medical D.B.A. Xenix Medical →The one decision as Ht Medical, LLC Dba Xenix Medical →