MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | MAX |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Recent Cleared Devices (20 of 890)
Showing 20 most recent of 890 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | Feb 26, 2026 | SESE |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | Feb 23, 2026 | SESE |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | Feb 4, 2026 | SESE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | Jan 23, 2026 | SESE |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | Jan 8, 2026 | SESE |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | Dec 19, 2025 | SESE |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | Nov 25, 2025 | SESE |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | Oct 28, 2025 | SESE |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Oct 24, 2025 | SESE |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | Sep 18, 2025 | SESE |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | Sep 4, 2025 | SESE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | Aug 15, 2025 | SESE |
| K252113 | PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices | Aug 5, 2025 | SESE |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | Jul 17, 2025 | SESE |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | Jul 8, 2025 | SESE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | Jul 7, 2025 | SESE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. | Jul 7, 2025 | SESE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | Jun 30, 2025 | SESE |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | Jun 27, 2025 | SESE |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | Jun 25, 2025 | SESE |
Top Applicants
- Nu Vasive, Incorporated — 34 clearances
- Medtronic Sofamor Danek USA, Inc. — 32 clearances
- Life Spine, Inc. — 25 clearances
- Spineology, Inc. — 22 clearances
- Globus Medical, Inc. — 20 clearances
