510(k) Report

510(k) · Cleared

Cleared

Diana Fusion Cage

K091122510(k) TraditionalCleared Sep 18, 2009154-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

Signus Medical · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Sep 18, 2009 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 3 other predicates after a 154-day review. Its family tree reaches back 1 generation to 1996.

Decided
Sep 18, 2009
Review
154 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to P950002 (1996). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1996: 1 other ancestorP950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19961995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors P950002 · Bak Interbody Fusion System · Zimmer Spine, Inc. · 19960
  1. Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
  2. This deviceK091122 Diana Fusion CageSignus Medical · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P950002Bak Interbody Fusion SystemZimmer Spine, Inc.1996—
0 (this device)K091122Diana Fusion CageSignus Medical2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
FIG. 1 — Lineage of K091122, 1996–2009Source: 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 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAX? 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

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*P950002Bak Interbody Fusion System
Summary page 1
…the same indications for use, design, function, and materials used. . The four formerly Class III predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Br…
Zimmer Spine, Inc.1996—
*P970015Inter Fix Threaded Fusion Device
Summary page 1
…als used. . The four formerly Class III predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). Performance Testing: The pre-clini…
Sofamor Danek19991
*P950019Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation
Summary page 1
…nclude the BAK Interbody Fusion Device (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). Performance Testing: The pre-clinical testing performed indicated that the DIANATM Fusion Cag…
Stryker Spine19961
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…evice (Spine-Tech, P950002), Inter Fix Threaded Fusion Device (Sofamor Danek, P970015), the Ray Threaded Fusion Cage (Surgical Dynamics, P950019) and the Brantigan Cage (P960025). Performance Testing: The pre-clinical testing performed indicated that the DIANATM Fusion Cage is substantially equivalent to…
Depuy Spine, Inc.1999—

Also cleared against P950002: 34 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 4 ancestors have a recall of any class.
  • 34 other devices also cite its predicate P950002.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The DIANATM Fusion Cage is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Indications for use as stated in the FDA summary.

Also cleared against P950002

34 other devices cite the same predicate.

  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K143479Bluefin Interbody SystemTides Medical · 2015

More from Signus Medical

2 FDA decisions under this applicant name. See the company

  • K092073Monopoly Pedicle Screw SystemSignus Medical · 2009

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/K091122 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091122: Diana Fusion Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091122

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026