510(k) Report

510(k) · Cleared

Cleared

Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White Implants (Alif)

K102322510(k) TraditionalCleared Jan 7, 2011143-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

Omni Surgical, L.P. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jan 7, 2011 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 3 other predicates after a 143-day review. Its family tree reaches back 9 generations to 1984. 6 later devices descend from it.

Decided
Jan 7, 2011
Review
143 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K841189 (1984). 27 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2001: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2005: 1 other ancestor2004: 4 other ancestors2003: 2 other ancestors2002: 3 other ancestors2000: 1 other ancestor2013: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 4 other ancestors5 generations back: 5 other ancestors6 generations back: 2 other ancestors7 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−50
  1. Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations between
  3. 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  4. 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  5. 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  6. This deviceK102322 Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant…Omni Surgical, L.P. · 2011
  7. Descendant · cites it directly · 5 of its ownK131981 Cezanne II Interbody Fusion SystemAccel Spine · 2013 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK192863 MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020
  9. Descendant · 3 generations on · 1 of its ownK213641 MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
  10. Descendant · 2 generations on · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
  11. Descendant · 3 generations on · 0 of its ownK220513 NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
Show all 9 generations
  1. Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. This deviceK102322 Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant…Omni Surgical, L.P. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12020: 12021: 12022: 12023: 12024: 1
2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K131981Cezanne II Interbody Fusion SystemAccel Spine · 2013 · cites it directly5descendants
  • K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 2020 · 2 generations on3descendants
  • K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022 · 3 generations on1descendant
  • K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · 2 generations on0descendants
  • K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−8K990148Stackable Cage SystemDepuy Motech Acromed1999—
−7K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−6K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−5K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−4K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−3K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−2K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−1K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
0 (this device)K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger…Omni Surgical, L.P.2011—
+1K131981Cezanne II Interbody Fusion SystemAccel Spine20134
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation2022—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation2024—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200140
200230
200320
200440
200510
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
202010
202110
202210
202310
202410
FIG. 1 — Lineage of K102322, 1984–2024Source: 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
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…ices which are substantially equivalent: Spine 360 Interbody Fusion System is substantially equivalent to the following devices. * BRANTIGAN I/F CAGE (P960025) * Lucent Straight Intervertebral Body Fusion Device (K072120) 4. Description of the device: The SHARK implant…
Depuy Spine, Inc.1999—
*K072120Paramount Intervertebral Body Fusion Device
Summary page 1
…System is substantially equivalent to the following devices. * BRANTIGAN I/F CAGE (P960025) * Lucent Straight Intervertebral Body Fusion Device (K072120) 4. Description of the device: The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK…
Innovative Spinal Technologies, Inc.2007—
*K073351Crystal
Summary page 2
…Cage _______ _______ _______ 510(k) number -- K073351 P980048 53 P960025 K072120 Intended use Per 888.3080 Per 888.3080…
Spinal Elements, Inc.2008—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 2
…Cage _______ _______ _______ 510(k) number -- K073351 P980048 53 P960025 K072120 Intended use Per 888.3080 Per 888.3080 Per 888.3080…
Sulzer Spine-Tech2001—

Also cleared against P960025: 98 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131981Cezanne II Interbody Fusion SystemAccel Spine20135

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?

  • The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 27 ancestors have a recall of any class.
  • Of its descendants, K131981 (Accel Spine, 2013) has gone furthest, with 5 descendants of its own.
  • 98 other devices also cite its predicate P960025.

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. 2011, 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 Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the…

Read the full statement (133 words)

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DODD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Indications for use as stated in the FDA summary.

Also cleared against P960025

98 other devices cite the same predicate.

  • K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC · 2024
  • K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018

More from Omni Surgical, L.P.

2 FDA decisions under this applicant name. See the company

  • K081770Black Widow Anterior Buttress PlateOmni Surgical, L.P. · 20092 recalls

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/K102322 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102322: Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant (Tlif); Great White Implants (Alif).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102322

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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