510(k) · Cleared
ClearedPivotec Lumbar Interbody Fusion Device (Lifd)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Captiva Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 1, 2009 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 2 other predicates after a 148-day review. Its family tree reaches back 5 generations to 2001. 24 later devices descend from it.
- Decided
- Dec 1, 2009
- Review
- 148 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010530 (2001). 9 ancestors in all, the oldest P950002 (1996). 24 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 3 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 2 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 1 generation backK083661 Avs TL Peek SpacersStryker Corp. · 2009
- This deviceK092017 Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017
- Descendant · cites it directly · 8 of its ownK181702 Tranquil-L Interbody SystemNexus Spine, LLC · 2018
- Descendant · 2 generations on · 7 of its ownK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
- Descendant · 2 generations on · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 3 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K170297Tranquil Interbody SystemNexus Spine, LLC · 2017 · cites it directly15descendants
- K181702Tranquil-L Interbody SystemNexus Spine, LLC · 2018 · cites it directly8descendants
- K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022 · 2 generations on7descendants
- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · 2 generations on7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −3 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −2 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −1 | K083661 | Avs TL Peek Spacers | Stryker Corp. | 2009 | — |
| 0 (this device) | K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd) | Captiva Spine, Inc. | 2009 | — |
| +1 | K170297 | Tranquil Interbody System | Nexus Spine, LLC | 2017 | — |
| +1 | K181702 | Tranquil-L Interbody System | Nexus Spine, LLC | 2018 | — |
| +2 | K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022 | — |
| +2 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +3 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 MAX? 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? (3)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…MAX Predicate Device(s): The subject device is substantially equivalent to the following devices: Lumbar h/F Cage (P960025) Marketed and distributed by DePuy Ray Threaded Fusion Cage (TFC)TM (P950019)… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…ces: Lumbar h/F Cage (P960025) Marketed and distributed by DePuy Ray Threaded Fusion Cage (TFC)TM (P950019) Marketed and distributed by Stryker (originally approved by Surgical Dynamics)… | 1996 |
| * | K083661 | Avs TL Peek SpacersSummary page 1…Marketed and distributed by Stryker (originally approved by Surgical Dynamics) AVS TL PEEK Spacer (K083661) Marketed and distributed by Stryker Device Description: The Pivotec LIFD is an intervertebral body fu… | 2009 |
What descends from it? (24)
See all 244 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K170297 (Nexus Spine, LLC, 2017) has gone furthest, with 15 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2009, 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 Pivotec LIFD implant is an intervertebral body fusion deviceindicated for interertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092017: Pivotec Lumbar Interbody Fusion Device (Lifd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092017
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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