PMA · Approved

Approved

Bak Interbody Fusion System

P950002PMAApproved Sep 20, 1996612-day reviewClass II21 CFR 888.3080

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

Zimmer Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on Sep 20, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 612-day review. 2 of the 1,682 devices in its family, counting itself, have a Class I recall. 1,681 later devices descend from it.

Decided: Sep 20, 1996
Review: 612 days
Class: Class II
Product code: MAX
Recalls: None

1,681 later devices descend from it, 35 citing it directly. 2 of the 1,682 devices in this family, counting this one, have a Class I recall.

This deviceP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
Descendant · cites it directly · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
Descendant · cites it directly · 1,250 of its ownK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
Descendant · cites it directly · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
Descendant · 2 generations on · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
Descendant · 3 generations on · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008

Showing 5 of 1,681 descendants. See all descendants

Descendants cleared per year

2007high 139 (2023) · low 4 (2007)2026

Class I recalls in this family

K073202 Ardis Spacercites it directly · 2008
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,681 · See all

K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · cites it directly1,405descendants
K072253Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · cites it directly1,250descendants
K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly1,103descendants
K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · 2 generations on1,102descendants
K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · 3 generations on1,091descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P950002	Bak Interbody Fusion System	Zimmer Spine, Inc.	1996	—
+1	K072120	Paramount Intervertebral Body Fusion Device	Innovative Spinal Technologies, Inc.	2007	—
+1	K072253	Synfix-LR Spacer	Synthes Spine Co.Lp	2007	1
+1	K073291	Capstone Spinal System	Medtronic Sofamor Danek USA, Inc.	2008	—
+2	K073470	Avs PL Peek Spacers, Models 48351XXX and 48353XXX	Stryker Spine	2008	—
+3	K080758	Avs PL Peek Spacers, Models 48351 and 48353	Stryker Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	4	0
2008	24	1
2009	21	0
2010	38	0
2011	58	0
2012	58	0
2013	68	0
2014	93	0
2015	80	0
2016	101	0
2017	128	0
2018	115	0
2019	115	0
2020	109	0
2021	107	1
2022	106	0
2023	139	0
2024	126	0
2025	102	0
2026	89	0

FIG. 1 — Lineage of P950002, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MAX device

#1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (1,681)

See all 1,681

35 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072120	Paramount Intervertebral Body Fusion Device	Innovative Spinal Technologies, Inc.	2007	1,405
K072253	Synfix-LR Spacer	Synthes Spine Co.Lp	2007	1,250
K073291	Capstone Spinal System	Medtronic Sofamor Danek USA, Inc.	2008	1,103
K081917	Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems	Depuy Spine, Inc.	2009	1,008
K080083	Intrepid Spinal System	Medtronic Sofamor Danek	2008	932
K100042	Difusion Technologies Xiphos Interbody Fusion System	Difusion Technologies	2010	864
K072226	Impix Spacer	Medicrea Technologies	2007	812
K090353	Perimeter Interbody Fusion Device	Medtronic Sofamor Danek	2009	796
K090064	Eminent Spine Interbody Fusion System	Eminent Spine	2009	701
K073202	Ardis Spacer Class I	Abbott Spine, Inc.	2008	644

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K073202Ardis SpacerAbbott Spine, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K072120 (Innovative Spinal Technologies, Inc., 2007) has gone furthest, with 1,405 descendants of its own.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/P950002 · printed Nov 6, 2026

Cite this page

510(k) Report. “P950002: Bak Interbody Fusion System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950002

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026