510(k) Report

FDA applicant

Integrity Implants Inc. Dba Accelus

Palm Beach Gardens, FL1 decision2025–20250 recalls

FDA records 1 decision for Integrity Implants Inc. Dba Accelus (Palm Beach Gardens, FL) in 2025: 1 510(k) clearance. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 2 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 Integrity Implants Inc. Dba Accelus’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Integrity Implants Inc. Dba Accelus by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus · 2025

The one decision as Integrity Implants Inc. Dba Accelus →

Other applicant names beginning “Integrity”

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

Integrity Implants, Inc. 11Integrity Spine 2Integrity Optics, Inc. 2Integrity Practice Management, Inc. 1Integrity Life Sciences 1Integrity Medical Software, Inc. 1Integrity Spine Lumbar Interbody Fusion System 1Integrity Orthopaedics, Inc. 1