510(k) Report

FDA applicant

Integrity Implants, Inc.

Palm Beach Gardens, FL11 decisions2019–20234 recalls

FDA records 11 decisions for Integrity Implants, Inc. (Palm Beach Gardens, FL) from 2019 to 2023: 11 510(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 126 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 15 of them its own earlier devices. 4 recalls are 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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 32020: 32021: 22022: 22023: 1
2019high 3 (2019) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

4in 2022

2022: 4
2019high 4 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Integrity Implants, Inc. by year, 2019–2026Sources: 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, Lumbar7decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • OLOOrthopedic Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 126 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 3 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 39 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 15 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.

  • K190360LineSider™ Spinal SystemIntegrity Implants, Inc. · 20195cite it
  • K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 20195cite it
  • K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 20193cite it
  • K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 20212cite it
  • K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 20202cite it
  • K203367LineSider™ Spinal SystemIntegrity Implants, Inc. · 20202cite it

What has FDA decided for it lately?

  • K231098LineSider® Spinal SystemIntegrity Implants, Inc. · 2023
  • K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
  • K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2022
  • K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. · 2021
  • K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
  • K203367LineSider™ Spinal SystemIntegrity Implants, Inc. · 20204 recalls
  • K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2020
  • K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020

All 11 as Integrity Implants, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K203367LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead…Aug 3, 2022Class II
  • K203367LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.…Jan 27, 2022Class II
  • K203367LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated.…Jan 27, 2022Class II
  • K203367LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated.…Jan 27, 2022Class II

Other applicant names beginning “Integrity”

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

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