510(k) Report

PMA · Approved

Approved

Bak/Cervical (Bak/C) Interbody Fusion System

P980048PMAApproved Apr 20, 2001857-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

Sulzer Spine-Tech · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on Apr 20, 2001 through premarket approval, which rests on the device’s own clinical evidence after an 857-day review. 1 of the 1,423 devices in its family, counting itself, has a Class I recall. 1,422 later devices descend from it.

Decided
Apr 20, 2001
Review
857 days
Class
Class II
Product code
MAX
Recalls
None

1,422 later devices descend from it, 54 citing it directly. 1 of the 1,423 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2013: 48 descendants cleared2021: 91 descendants cleared, 1 with a Class I recall12009: 8 descendants cleared2007: 1 descendant cleared2011: 48 descendants cleared2019: 103 descendants cleared2017: 120 descendants cleared2010: 22 descendants cleared2026: 79 descendants cleared2012: 41 descendants cleared2016: 92 descendants cleared2008: 12 descendants cleared2014: 80 descendants cleared2018: 109 descendants cleared2015: 83 descendants cleared2020: 101 descendants cleared2023: 107 descendants cleared2024: 109 descendants cleared2022: 86 descendants cleared2025: 82 descendants cleared200020052010201520202025
  1. This deviceP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
  2. Descendant · cites it directly · 1,008 of its ownK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  3. Descendant · cites it directly · 948 of its ownK072415 Stalif (TM) CSurgicraft, Ltd. · 2008
  4. Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  5. Descendant · cites it directly · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  6. Descendant · cites it directly · 840 of its ownK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008

Showing 5 of 1,422 descendants. See all descendants

Descendants cleared per year

2007: 12008: 122009: 82010: 222011: 482012: 412013: 482014: 802015: 832016: 922017: 1202018: 1092019: 1032020: 1012021: 912022: 862023: 1072024: 1092025: 822026: 79
2007high 120 (2017) · low 1 (2007)2026

Class I recalls in this family

  • K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 1,422 · See all
  • K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009 · cites it directly1,008descendants
  • K072415Stalif (TM) CSurgicraft, Ltd. · 2008 · cites it directly948descendants
  • K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 2 generations on907descendants
  • K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · cites it directly901descendants
  • K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008 · cites it directly840descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P980048Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech2001—
+1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.2009—
+1K072415Stalif (TM) CSurgicraft, Ltd.2008—
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
+1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
+1K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
2008120
200980
2010220
2011480
2012410
2013480
2014800
2015830
2016920
20171200
20181090
20191030
20201010
2021911
2022860
20231070
20241090
2025820
2026790
FIG. 1 — Lineage of P980048, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has 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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (1,422)

See all 1,422

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

NumberDeviceApplicantDecidedDescendants
K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008
K072415Stalif (TM) CSurgicraft, Ltd.2008948
K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901
K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840
K072226Impix SpacerMedicrea Technologies2007812
K112036Calix PC Spinal Implant SystemX-Spine Systems, Inc.2011775
K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology2008775
K090064Eminent Spine Interbody Fusion SystemEminent Spine2009701
K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637
K072981Synthes Zero-PSynthes Spine Co.Lp2008546

Has anything in its family been recalled? (1 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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K081917 (Depuy Spine, Inc., 2009) has gone furthest, with 1,008 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

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
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

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

More from Sulzer Spine-Tech

11 FDA decisions under this applicant name. See the company

  • P980048/S003Bak/C Vista Cervical Interbody Fusion DeviceSulzer Spine-Tech · 2004
  • K022374Cadence Spinal Fixation SystemSulzer Spine-Tech · 20021 recall
  • P980048/S002Bak/Cervical (Bak/C) (R) Interbody Fusion SystemSulzer Spine-Tech · 2002
  • K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech · 2002
  • K020196Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 2002

Recent decisions in MAX

The MAX category page

  • 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

https://510kreport.com/device/P980048 · printed Nov 6, 2026

Cite this page

510(k) Report. “P980048: Bak/Cervical (Bak/C) 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/P980048

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