510(k) · Cleared
ClearedInterbody Fusion (IBF)/Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rti Surgical, Inc. Dba Rti Biologics · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 15, 2015 as substantially equivalent to K133455 (Pioneer Surgical Technology, Inc., 2014) and 6 other predicates after a 74-day review. Its family tree reaches back 13 generations to 1984. 12 later devices descend from it.
- Decided
- May 15, 2015
- Review
- 74 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K841189 (1984). 64 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 2 generations backK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- 1 generation backK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · Recalled
- This deviceK150521 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2015
- Descendant · cites it directly · 11 of its ownK170643 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
- Descendant · 2 generations on · 10 of its ownK172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK190498 Fortilink® IBF System with TETRAfuse®3D Technology, include the…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · 4 generations on · 5 of its ownK192718 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019
- Descendant · 5 generations on · 4 of its ownK201453 Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 3 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 2 generations backK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- 1 generation backK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · Recalled
- This deviceK150521 Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017 · cites it directly11descendants
- K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc. · 2017 · 2 generations on10descendants
- K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019 · 3 generations on7descendants
- K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2019 · 4 generations on5descendants
- K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −3 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −2 | K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014 | — |
| −1 | K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| 0 (this device) | K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2015 | — |
| +1 | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2017 | — |
| +2 | K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Rti Surgical, Inc. | 2017 | — |
| +3 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following… | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +4 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019 | — |
| +5 | K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K133455 | Crossfuse II Coronal Taper, Crossfuse II HyperlordoticSummary page 6…Panel/ Branch: Orthopedic and Rehabilitation Devices Panel; Panel Code 87 Restorative Devices Branch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices… | 2014 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 6…el; Panel Code 87 Restorative Devices Branch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Inte… | 2005 |
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 6…Code 87 Restorative Devices Branch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Interbody Sys… | 2006 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 6…Restorative Devices Branch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Interbody System (K142… | 2008 |
| * | K112496 | Pioneer Crossfuse II Ibf/VBR SystemSummary page 6…Restorative Devices Branch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Interbody System (K142050) Des… | 2011 |
| * | K133623 | C-PLUSSummary page 6…anch Primary Predicate Pioneer IBF/VBR System K133455 Device: Additional Pioneer IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Interbody System (K142050) Description: The system inclu… | 2014 |
| * | K142050 | Nuvasive Coroent Small Contoured Interbody SystemSummary page 6…er IBF/VBR System (K043206, K061151, K073177, K112496, and Predicate K133623) Devices: NuVasive® CoRoent® Small Contoured Interbody System (K142050) Description: The system includes implantable devices manufactured from PEEK with tantalum or titaniu… | 2014 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | 2017 | 11 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 64 ancestors have a recall of any class.
- Of its descendants, K170643 (Rti Surgical, Inc. Dba Rti Biologics, 2017) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K133455.
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. 2015, 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?
When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration…
Read the full statement (475 words)
When used as a cervical intervertebral body fusion device (C-Plus), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2-C3 disc to the C7-T1 disc, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Streamline OCT, SlimFuse, Cequence, PAC, or Aspect Systems.
When used as a lumbar intervertebral body fusion device (Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse IT), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level, such as Quantum, Streamline TL, Contact ALP, Streamline MIS Systems, or Lat-Fuse Lateral Plate System.
When used as a vertebral body replacement (VBR) device (C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, CrossFuse, and CrossFuse II), the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System (“IBF/VBR System”) is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1-L5) such as the Streamline TL Spinal Fixation System, Streamline MIS Spinal Fixation System or Quantum Spinal Fixation System. Additionally, the VBR device is intended to be used with bone graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150521: Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150521
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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