510(k) Report

PMA · Approved

Recalled · 2008

Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation

P950019PMAApproved Oct 29, 1996503-day reviewClass II21 CFR 888.3080Recalls 1

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

Stryker Spine · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Approved on Oct 29, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 503-day review. 1 of the 1,483 devices in its family, counting itself, has a Class I recall. 1,482 later devices descend from it. It has been recalled once.

Decided
Oct 29, 1996
Review
503 days
Class
Class II
Product code
MAX
Recalls
1

1,482 later devices descend from it, 38 citing it directly. 1 of the 1,483 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 16 descendants cleared2012: 38 descendants cleared2013: 52 descendants cleared2016: 84 descendants cleared2011: 29 descendants cleared2010: 22 descendants cleared2008: 17 descendants cleared2015: 62 descendants cleared2017: 116 descendants cleared2014: 68 descendants cleared2023: 137 descendants cleared2020: 104 descendants cleared2021: 104 descendants cleared, 1 with a Class I recall12022: 104 descendants cleared2024: 125 descendants cleared2019: 112 descendants cleared2018: 103 descendants cleared2025: 100 descendants cleared2026: 89 descendants cleared1995200020052010201520202025
  1. This deviceP950019 Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine · 1996
  2. Descendant · cites it directly · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  3. Descendant · cites it directly · 1,102 of its ownK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
  4. Descendant · 2 generations on · 1,091 of its ownK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
  5. Descendant · 2 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
  6. Descendant · cites it directly · 932 of its ownK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled

Showing 5 of 1,482 descendants. See all descendants

Descendants cleared per year

2008: 172009: 162010: 222011: 292012: 382013: 522014: 682015: 622016: 842017: 1162018: 1032019: 1122020: 1042021: 1042022: 1042023: 1372024: 1252025: 1002026: 89
2008high 137 (2023) · low 16 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 1,482 · See all
  • K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · cites it directly1,103descendants
  • K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008 · cites it directly1,102descendants
  • K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008 · 2 generations on1,091descendants
  • K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on1,008descendants
  • K080083Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly932descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P950019Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationStryker Spine1996—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
+1K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine2008—
+2K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.2008—
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek2010—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088

Descendants by year cleared

Year clearedDevicesWith a Class I recall
2008170
2009160
2010220
2011290
2012380
2013520
2014680
2015620
2016840
20171160
20181030
20191120
20201040
20211041
20221040
20231370
20241250
20251000
2026890
FIG. 1 — Lineage of P950019, 1996–2026Source: 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? (1,482)

See all 1,482

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

NumberDeviceApplicantDecidedDescendants
K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103
K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102
K080083Intrepid Spinal SystemMedtronic Sofamor Danek2008932
K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864
K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc.2008848
K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838
K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796
K090064Eminent Spine Interbody Fusion SystemEminent Spine2009701
K092901Epicage Interbody Fusion DeviceR Tree Innovations2010609
K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 18, 2008Not classifiedZ-0151-2009Labeling mix-upsThe label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.

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

What does this lineage say?

  • Of its descendants, K073291 (Medtronic Sofamor Danek USA, Inc., 2008) has gone furthest, with 1,103 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 Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

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/P950019 · printed Nov 6, 2026

Cite this page

510(k) Report. “P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950019

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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