510(k) · Cleared
ClearedStingray Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Surgical, LP Dba Spine360 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 17, 2012 as substantially equivalent to K082801 (Us Spine, 2008) and 1 other predicate after a 93-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Oct 17, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK122085 Stingray Cervical CageOmni Surgical, LP Dba Spine360 · 2012
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
- This deviceK122085 Stingray Cervical CageOmni Surgical, LP Dba Spine360 · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −1 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| 0 (this device) | K122085 | Stingray Cervical Cage | Omni Surgical, LP Dba Spine360 | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082801 | Phantom Plus Cage SystemSummary page 2…Phantom Plus Cage BAKe ______________ Stingray 510(k) number -- K082801 P980048 S3 Intended use Per 888.3080 Per 888.3080 Per 888.… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…Fusion System is substantially equivalent to the following devices. * US Spine Phantom Plus Cage (1(082801) " Zimmer BAK/C Vista Interbody Fusion (P980048 S3) 4. Description of the device: The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervic… | 2001 |
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?
- The line of descent spans 28 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 12 other devices also cite its predicate K082801.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Spine3EO Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. OIDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the…
Read the full statement (119 words)
The Spine3EO Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. OIDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to Ti disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122085: Stingray Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122085
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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