510(k) · Cleared
Recalled · Class II · 2016AccuLIF TL and PL Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 5, 2015 as substantially equivalent to K143163 (Stryker Corporation, 2015) and 1 other predicate after a 76-day review. Its family tree reaches back 17 generations to 1984. 469 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 5, 2015
- Review
- 76 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 17 generations to K841189 (1984). 120 ancestors in all. 469 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK143616 AccuLIF TL and PL CageStryker Corporation · 2015
- Descendant · cites it directly · 448 of its ownK152304 Tritanium PL CageStryker · 2015 · Recalled
- Descendant · 2 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 2 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 178 of its ownK160955 Tritanium® PL CageStryker · 2016
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 4 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK143616 AccuLIF TL and PL CageStryker Corporation · 2015
Showing 5 of 469 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 469 · See all- K152304Tritanium PL CageStryker · 2015 · cites it directly448descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 2 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 2 generations on276descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on227descendants
- K160955Tritanium® PL CageStryker · 2016 · 2 generations on178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −4 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −2 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| 0 (this device) | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | — |
| +1 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| +2 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +2 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +2 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 15 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 15 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 31 | 0 |
| 2020 | 46 | 0 |
| 2021 | 44 | 0 |
| 2022 | 54 | 0 |
| 2023 | 73 | 0 |
| 2024 | 65 | 0 |
| 2025 | 62 | 0 |
| 2026 | 54 | 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? (2)
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 |
|---|---|---|---|
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer… Cleared while this submission was under review Summary page 4…ate Devices The AccullF® TL and PL Cage was shown to be substantially equivalent to the device listed below: e Primary Predicate: Stryker Spine, ACCULIFPTL and PL Cage K143163 * Additional Predicate: Medtronic, Capstone Spinal System, K123027 Device Description The AccullF TL and PL Cage device is an e… | 2015 |
| * | K123027 | Capstone (R) Spinal SystemSummary page 4…lly equivalent to the device listed below: e Primary Predicate: Stryker Spine, ACCULIFPTL and PL Cage K143163 * Additional Predicate: Medtronic, Capstone Spinal System, K123027 Device Description The AccullF TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Tit… | 2013 |
What descends from it? (469)
See all 4693 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2016 | Class II | Z-2788-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
| Jul 26, 2016 | Class II | Z-2786-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
| Jul 26, 2016 | Class II | Z-2787-2016 | Unknown/Undetermined by firm | Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative… |
| Dec 16, 2015 | Class II | Z-0852-2016 | Device Design | There were two potential interference conditions identified with the way the tubing set attaches to the inserter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 12 of the 120 ancestors have a recall of any class.
- Of its descendants, K152304 (Stryker, 2015) has gone furthest, with 448 descendants of its own.
- 11 other devices also cite its predicate K143163.
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. 2015, 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 AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (178 words)
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
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/K143616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143616: AccuLIF TL and PL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143616
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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