510(k) · Cleared
Recalled · Class II · 2015Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 27, 2014 as substantially equivalent to K112496 (Pioneer Surgical Technology, Inc., 2011) and 5 other predicates after a 135-day review. Its family tree reaches back 12 generations to 1984. 1 of the 634 devices in its family, counting itself, has a Class I recall. 596 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 12 generations to K841189 (1984). 37 ancestors in all. 596 later devices descend from it, 4 citing it directly. 1 of the 634 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 2 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- This deviceK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014
- Descendant · cites it directly · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- Descendant · 4 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 2 generations backK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- This deviceK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014
Showing 5 of 596 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 596 · See all- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · cites it directly588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 2 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 2 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 3 generations on400descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 4 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −2 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014 | — |
| 0 (this device) | K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | Pioneer Surgical Technology, Inc. | 2014 | — |
| +1 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +2 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +2 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +3 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| +4 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 7 | 0 |
| 2016 | 17 | 0 |
| 2017 | 29 | 0 |
| 2018 | 31 | 0 |
| 2019 | 45 | 0 |
| 2020 | 65 | 0 |
| 2021 | 51 | 1 |
| 2022 | 62 | 0 |
| 2023 | 76 | 0 |
| 2024 | 83 | 0 |
| 2025 | 72 | 0 |
| 2026 | 58 | 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K112496 | Pioneer Crossfuse II Ibf/VBR System | 2011 |
| * | K133623 | C-PLUS Cleared while this submission was under review Summary page 1…11 Product Codes: MAX, ODP, MQP Panel! Branch: Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 Predicates: Pioneer IBFIVBR System Ki 12496 &K133623 Pioneer IBF System K073 177 Pioneer VBR System K043206 & K061 151 NuVasi… | 2014 |
| * | K073177 | Pioneer Intervertebral Fusion Device SystemSummary page 1…ranch: Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 Predicates: Pioneer IBFIVBR System Ki 12496 &K133623 Pioneer IBF System K073 177 Pioneer VBR System K043206 & K061 151 NuVasive CoRoent System (K071 795) Description:… | 2008 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 1…es Panel; Panel Code 87 Predicates: Pioneer IBFIVBR System Ki 12496 &K133623 Pioneer IBF System K073 177 Pioneer VBR System K043206 & K061 151 NuVasive CoRoent System (K071 795) Description: The Interbody Fusion (IBF) / Vertebral Body… | 2005 |
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 1…Panel Code 87 Predicates: Pioneer IBFIVBR System Ki 12496 &K133623 Pioneer IBF System K073 177 Pioneer VBR System K043206 & K061 151 NuVasive CoRoent System (K071 795) Description: The Interbody Fusion (IBF) / Vertebral Body Replacement… | 2006 |
| * | K071795 | Nuvasive Coroent SystemSummary page 1…tem Ki 12496 &K133623 Pioneer IBF System K073 177 Pioneer VBR System K043206 & K061 151 NuVasive CoRoent System (K071 795) Description: The Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System consists of a variet… | 2007 |
What descends from it? (596)
See all 5964 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2015 | Class II | Z-1916-2015 | Error in labeling | Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial. |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K141665 (Nuvasive, Inc., 2015) has gone furthest, with 588 descendants of its own.
- 5 other devices also cite its predicate K112496.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 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 (463 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 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 II), 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 I 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 as stated in the FDA summary.
https://510kreport.com/device/K133455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133455
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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