510(k) Report

PMA · Approved

Approved

Affinity (TM) Cage System

P000028PMAApproved Jun 13, 2002702-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

Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on Jun 13, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 702-day review. 1 of the 1,288 devices in its family, counting itself, has a Class I recall. 1,287 later devices descend from it.

Decided
Jun 13, 2002
Review
702 days
Class
Class II
Product code
MAX
Recalls
None

1,287 later devices descend from it, 16 citing it directly. 1 of the 1,288 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2015: 65 descendants cleared2017: 111 descendants cleared2012: 30 descendants cleared2013: 38 descendants cleared2011: 36 descendants cleared2010: 14 descendants cleared2009: 6 descendants cleared2008: 7 descendants cleared2014: 60 descendants cleared2020: 99 descendants cleared2016: 82 descendants cleared2018: 101 descendants cleared2026: 78 descendants cleared2019: 100 descendants cleared2023: 105 descendants cleared2024: 104 descendants cleared2021: 88 descendants cleared, 1 with a Class I recall12022: 82 descendants cleared2025: 81 descendants cleared200020052010201520202025
  1. This deviceP000028 Affinity (TM) Cage SystemMedtronic Sofamor Danek USA, Inc. · 2002
  2. Descendant · cites it directly · 1,018 of its ownK073320 Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008
  3. Descendant · 2 generations on · 1,008 of its ownK081917 Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009
  4. Descendant · cites it directly · 948 of its ownK072415 Stalif (TM) CSurgicraft, Ltd. · 2008
  5. Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  6. Descendant · cites it directly · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009

Showing 5 of 1,287 descendants. See all descendants

Descendants cleared per year

2008: 72009: 62010: 142011: 362012: 302013: 382014: 602015: 652016: 822017: 1112018: 1012019: 1002020: 992021: 882022: 822023: 1052024: 1042025: 812026: 78
2008high 111 (2017) · low 6 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 1,287 · See all
  • K073320Cimplicity Spinal SystemSpine Smith Partners L.P. · 2008 · cites it directly1,018descendants
  • K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc. · 2009 · 2 generations on1,008descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P000028Affinity (TM) Cage SystemMedtronic Sofamor Danek USA, Inc.2002—
+1K073320Cimplicity Spinal SystemSpine Smith Partners L.P.2008—
+2K081917Depuy 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200870
200960
2010140
2011360
2012300
2013380
2014600
2015650
2016820
20171110
20181010
20191000
2020990
2021881
2022820
20231050
20241040
2025810
2026780
FIG. 1 — Lineage of P000028, 2002–2026Source: 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? (1,287)

See all 1,287

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

NumberDeviceApplicantDecidedDescendants
K073320Cimplicity Spinal SystemSpine Smith Partners L.P.20081,018
K072415Stalif (TM) CSurgicraft, Ltd.2008948
K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901
K090064Eminent Spine Interbody Fusion SystemEminent Spine2009701
K072981Synthes Zero-PSynthes Spine Co.Lp2008546
K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxZimmer Trabecular Metal Technology2011505
K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389
K102606Avs Anchor-C Cervical Cage SystemStryker Spine2011384
K120819Stalif CCentinel Spine, Inc.2012206
K103034Genesys Spine Interbody Fusion SystemGenesys Spine2010137

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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K073320 (Spine Smith Partners L.P., 2008) has gone furthest, with 1,018 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 Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/P000028 · printed Nov 4, 2026

Cite this page

510(k) Report. “P000028: Affinity (TM) Cage System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P000028

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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