510(k) · Cleared
Recalled · Class II · 2013Pioneer Intervertebral Fusion Device System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 13, 2008 as substantially equivalent to K061151 (Pioneer Surgical Technology, 2006) and 4 other predicates after a 182-day review. Its family tree reaches back 9 generations to 1984. 1 of the 808 devices in its family, counting itself, has a Class I recall. 775 later devices descend from it. It has been recalled once.
- Decided
- May 13, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 9 generations to K841189 (1984). 32 ancestors in all. 775 later devices descend from it, 12 citing it directly. 1 of the 808 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008
- Descendant · cites it directly · 604 of its ownK112496 Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · cites it directly · 598 of its ownK133623 C-PLUSPioneer Surgical Technology, Inc. · 2014
- Descendant · cites it directly · 596 of its ownK133455 Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 2 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- This deviceK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008
Showing 5 of 775 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 775 · See all- K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc. · 2011 · cites it directly604descendants
- K133623C-PLUSPioneer Surgical Technology, Inc. · 2014 · cites it directly598descendants
- K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 2014 · cites it directly596descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| 0 (this device) | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | — |
| +1 | K112496 | Pioneer Crossfuse II Ibf/VBR System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +1 | K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014 | — |
| +1 | K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 19 | 0 |
| 2016 | 33 | 0 |
| 2017 | 50 | 0 |
| 2018 | 47 | 0 |
| 2019 | 57 | 0 |
| 2020 | 79 | 0 |
| 2021 | 67 | 1 |
| 2022 | 73 | 0 |
| 2023 | 88 | 0 |
| 2024 | 94 | 0 |
| 2025 | 78 | 0 |
| 2026 | 65 | 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? (5)
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 |
|---|---|---|---|
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 1…icate Device: The subject device is substantially equivalent to various cleared devices, including Pioneer's Vertebral Spacer - K061151, Medicrea's Impix - K072226, IST's Paramount- K072120, and Synthes Spacer K072253 and… | 2006 |
| * | K072226 | Impix Spacer Cleared while this submission was under review Summary page 1…lly equivalent to various cleared devices, including Pioneer's Vertebral Spacer - K061151, Medicrea's Impix - K072226, IST's Paramount- K072120, and Synthes Spacer K072253 and P980048/BAK Cervical Interbody Fusion dev… | 2007 |
| * | K072120 | Paramount Intervertebral Body Fusion DeviceSummary page 1…cleared devices, including Pioneer's Vertebral Spacer - K061151, Medicrea's Impix - K072226, IST's Paramount- K072120, and Synthes Spacer K072253 and P980048/BAK Cervical Interbody Fusion device. Device Description:… | 2007 |
| * | K072253 | Synfix-LR SpacerSummary page 1…including Pioneer's Vertebral Spacer - K061151, Medicrea's Impix - K072226, IST's Paramount- K072120, and Synthes Spacer K072253 and P980048/BAK Cervical Interbody Fusion device. Device Description: The Pioneer Inter… | 2007 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…tebral Spacer - K061151, Medicrea's Impix - K072226, IST's Paramount- K072120, and Synthes Spacer K072253 and P980048/BAK Cervical Interbody Fusion device. Device Description: The Pioneer Intervertebral Body Fusion device system is a r… | 2001 |
What descends from it? (775)
See all 77512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112496 | Pioneer Crossfuse II Ibf/VBR System | 2011 | 604 |
| K133623 | C-PLUS | 2014 | 598 |
| K133455 | Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic | 2014 | 596 |
| K103111 | Forza Spacer System | 2011 | 343 |
| K100210 | TRANS1 Lateral Intervertebral Fusion Device, T | 2010 | 175 |
| K150500 | Px PEEK IBF System | 2015 | 58 |
| K092540 | C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody Spacer | 2010 | 45 |
| K120396 | Reliance Cervical Ibf System | 2012 | 25 |
| K112862 | Mecta-C | 2011 | 14 |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | 2015 | 12 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2013 | Class II | Z-0627-2014 | Labeling False and Misleading | As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body… |
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 · 5 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 8 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 32 ancestors have a recall of any class.
- Of its descendants, K112496 (Pioneer Surgical Technology, Inc., 2011) has gone furthest, with 604 descendants of its own.
- 7 other devices also cite its predicate K061151.
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. 2008, 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?
The Pioneer IBF device systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, LowTop or SlimFuse systems. The Cervical IBF device is intended for use at…
Read the full statement (203 words)
The Pioneer IBF device systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, LowTop or SlimFuse systems.
The Cervical IBF device is intended for use at one level in the cervical spine, from C3 to Ti, for the treatment of cervical disc disease (defined at 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.
The Lumbar IBF device system is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, 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. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073177: Pioneer Intervertebral Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073177
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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