510(k) · Cleared
ClearedPhantom Plus Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Spine · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Dec 22, 2008 as substantially equivalent to P950002 (Zimmer Spine, Inc., 1996) and 3 other predicates after an 89-day review. Its family tree reaches back 10 generations to 1984. 1 of the 672 devices in its family, counting itself, has a Class I recall. 643 later devices descend from it.
- Decided
- Dec 22, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K841189 (1984). 28 ancestors in all. 643 later devices descend from it, 13 citing it directly. 1 of the 672 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- This deviceK082801 Phantom Plus Cage SystemUs Spine · 2008
- Descendant · cites it directly · 455 of its ownK100889 Endoskeleton TCTitan Spine, LLC · 2010
- Descendant · cites it directly · 393 of its ownK093093 Small Plateau Spacer SystemLife Spine · 2010
- Descendant · 2 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 2 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 2 generations on · 289 of its ownK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- This deviceK082801 Phantom Plus Cage SystemUs Spine · 2008
Showing 5 of 643 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 643 · See all- K100889Endoskeleton TCTitan Spine, LLC · 2010 · cites it directly455descendants
- K093093Small Plateau Spacer SystemLife Spine · 2010 · cites it directly393descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 2 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 2 generations on324descendants
- K121649Construx Mini Peek TI Spacer SystemOrthofix · 2012 · 2 generations on289descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| 0 (this device) | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| +1 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| +1 | K093093 | Small Plateau Spacer System | Life Spine | 2010 | — |
| +2 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +2 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +2 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 13 | 0 |
| 2015 | 15 | 0 |
| 2016 | 26 | 0 |
| 2017 | 40 | 0 |
| 2018 | 36 | 0 |
| 2019 | 56 | 0 |
| 2020 | 59 | 0 |
| 2021 | 57 | 1 |
| 2022 | 57 | 0 |
| 2023 | 70 | 0 |
| 2024 | 67 | 0 |
| 2025 | 67 | 0 |
| 2026 | 63 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…Class II 3. Predicate or legally marketed device(s) which are substantially equivalent: * BAKTM Interbody Fusion System, BP/Lordotic Device: Sulzer Spine-Tech (P950002) * LUMBAR I/F Cage® System: Depuy Acromed (P960025) * PATRIOTTM Spacers: Globus Medical (K072970) * SHELL/… | 1996 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…ch are substantially equivalent: * BAKTM Interbody Fusion System, BP/Lordotic Device: Sulzer Spine-Tech (P950002) * LUMBAR I/F Cage® System: Depuy Acromed (P960025) * PATRIOTTM Spacers: Globus Medical (K072970) * SHELL/WAVE/LOOP Cages: Advanced Medical Technologies AG (K080401… | 1999 |
| * | K072970 | Patriot SpacersSummary page 1…ody Fusion System, BP/Lordotic Device: Sulzer Spine-Tech (P950002) * LUMBAR I/F Cage® System: Depuy Acromed (P960025) * PATRIOTTM Spacers: Globus Medical (K072970) * SHELL/WAVE/LOOP Cages: Advanced Medical Technologies AG (K080401) 4. Description of the device: The Phantom… | 2008 |
| * | K080401 | Shell Cage, Wave Cage, Loop CageSummary page 1…LUMBAR I/F Cage® System: Depuy Acromed (P960025) * PATRIOTTM Spacers: Globus Medical (K072970) * SHELL/WAVE/LOOP Cages: Advanced Medical Technologies AG (K080401) 4. Description of the device: The PhantomTM Plus Cage System consists of a variety of hollow vertebral body spacers f… | 2008 |
What descends from it? (643)
See all 64313 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100889 | Endoskeleton TC | 2010 | 455 |
| K093093 | Small Plateau Spacer System | 2010 | 393 |
| K101363 | VU Cpod Intervertebral Bodu Fusion Device | 2010 | 78 |
| K103655 | Octane-C Interbody Fusion Device System | 2011 | 48 |
| K132582 | Exactech Acapella One Cervical Spacer System | 2014 | 47 |
| K121741 | 4-Web Cervical STS (Spinal Truss System) | 2012 | 35 |
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | 2016 | 13 |
| K153517 | AnyPlus® Cervical PEEK Cage System | 2016 | 12 |
| K132991 | C-Box Peek Cervical Ibf | 2014 | 9 |
| K121892 | Phantom Plus Ceramic Cage System | 2012 | 7 |
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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K100889 (Titan Spine, LLC, 2010) has gone furthest, with 455 descendants of its own.
- 34 other devices also cite its predicate P950002.
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. 2008, 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 PhantomTM Plus Cages- Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to SI. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be…
Read the full statement (224 words)
The PhantomTM Plus Cages- Lumbar are intervertebral body fusion devices indicated for use with
autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous
levels from L2 to SI.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and
radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved
level(s). These patients should be skeletally mature and have six (6) months of nonoperative therapy.
The PhantomTM Plus Cage System- Lumbar is to be filled with autogenous bone graft material. The
PhantomTM Plus Cages- Lumbar are intended to be used with supplemental spinal fixation systems, such as
Preference Pedicle Screw System.
PhantorrTm Plus Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc
disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and
radiographic studies. PhantomTMm Plus Cages-Cervical are used to facilitate int'ervertebral body fusion in the
cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.
PhantonmTM Plus Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6)
months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082801: Phantom Plus Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082801
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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