FDA product code · Orthopedic

Intervertebral Fusion Device With Bone Graft, Lumbar

Name: FDA decisions, review times, recalls and adverse event reports for product code MAX
Creator: 510(k) Report

MAXClass II21 CFR 888.3080510(k) required903 decisions since 199650 recalls

903 FDA decisions since 1996. 510(k) reviews decided 2021–2025 took a median of 94 days (half between 57 and 160). 50 recalls name this code, 1 of them Class I. The most-cited predicate is P960025, named by 99 later devices.

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of MAX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	86	0	12
2008	35	88	2	19
2009	31	102	9	90
2010	29	137	0	154
2011	49	98	3	201
2012	48	69	11 (1)	327
2013	58	102	0	380
2014	58	115	3	366
2015	53	113	1	524
2016	64	124	6	647
2017	76	116	1	596
2018	64	114	4	616
2019	60	131	1	699
2020	56	106	0	640
2021	53	109	0	622
2022	41	95	1	618
2023	30	87	0	576
2024	38	91	1	729
2025	29	85	5	811
2026	18	95	0	—

FIG. 1 — MAX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MAX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do MAX devices cite most?

Devices in this code that later submissions most often claim equivalence to.

P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsDepuy Spine, Inc. · 199999cite it
P980048Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 200154cite it
K071795Nuvasive Coroent SystemNuvasive, Inc. · 200742cite it
K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 200841cite it
K071724LucentSpinal Elements, Inc. · 200739cite it
P950019Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 199638cite it

Which MAX devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody…Carlsmed, Inc. · 202635generations
K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 202633generations
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody…SeaSpine Orthopedics Corporation · 202633generations
K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices · 202533generations
K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo®…Carlsmed, Inc. · 202533generations
K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 202533generations

What has FDA decided in MAX lately?

K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
K261049Scala® TLSpineart SA · 2026
K261430TruLift Expandable SystemLife Spine, Inc. · 2026
K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody…SeaSpine Orthopedics Corporation · 2026

All 903 MAX decisions →

What has been recalled in MAX lately?

K203576Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog…Orthofix U.S. LLC · Nov 3, 2025Class III
K172437Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System…Orthofix U.S. LLC · Nov 3, 2025Class III
K241164Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174Oct 29, 2025Class II
K241164Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000Oct 29, 2025Class II
K210425Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding…Medtronic Sofamor Danek USA Inc · Sep 16, 2025Class II
K232504Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate…Alphatec Spine, Inc. 1950 Camino Vida Roble · Dec 15, 2024Class II

Related product codes

Other codes under 21 CFR 888.3080.

OVE Intervertebral Fusion Device With Integrated…OVD Intervertebral Fusion Device With Integrated…ODP Intervertebral Fusion Device With Bone Graft…PHM Intervertebral Fusion Device With Bone Graft…