510(k) · Cleared
ClearedFule Interbody Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Fule Science & Technology Development Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 15, 2026 as substantially equivalent to K151726 (Stryker Corporation, 2016) and 3 other predicates after a 262-day review. Its family tree reaches back 19 generations to 1984.
- Decided
- Jun 15, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K841189 (1984). 128 ancestors in all. No later device cites it as a predicate yet.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK151726 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK…Stryker Corporation · 2016 · Recalled
- This deviceK253151 Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 1 generation backK151726 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK…Stryker Corporation · 2016 · Recalled
- This deviceK253151 Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −1 | K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL… | Stryker Corporation | 2016 | 1 |
| 0 (this device) | K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
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 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Summary page 6…mparable technological characteristics. Role 510(k) Legally Marketed Device Purpose in SE Rationale Number Primary K151726 Posterior Lumbar Primary predicate to which substantial Predicate Interbody Fusion Cage… | 2016 |
| * | K120486 | Avs as Peek SpacerSummary page 6…resistance, and sterile single-use configuration. Additional K120486 Anterior Cervical Interbody Additional predicate used to support the Predicate Fusion Cage… | 2012 |
| * | K100089 | Synthes T-Pal SpacerSummary page 6…cervical ACIF/ACDF configuration and Device cervical approach-specific indications. Additional K100089 T-PAL Posterior Lumbar Additional predicate used to support the Predicate Interbody Fusion Cage… | 2010 |
| * | K172828 | Double Medical Cage SystemSummary page 6…terbody Fusion Cage TLIF/T-PAL posterior lumbar approach- Device (TLIF) specific configuration. Additional K172828 OLIF Interbody Fusion Additional predicate used to support the Predicate Cage… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 15 of the 128 ancestors have a recall of any class.
- 4 other devices also cite its predicate K151726.
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. 2026, 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?
Cervical Spine (C2–T1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment…
Read the full statement (295 words)
Cervical Spine (C2–T1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one level of the cervical spine with accompanying radicular symptoms. Patients should have undergone at least six weeks of non-operative treatment prior to surgery.
The implants are intended to facilitate fusion in the cervical spine (C2–T1) and are placed via an anterior cervical approach, using autogenous bone graft. When used in the cervical spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the cervical spine, such as anterior cervical plate and screw fixation systems.
Lumbar Spine (L2–S1): The FULE Interbody Fusion Cage Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, at one or two contiguous levels of the lumbar spine (L2–S1). Patients should have undergone at least six months of non-operative treatment prior to surgery.
These implants are intended to facilitate fusion in the lumbar spine and are placed via an oblique lumbar interbody fusion (OLIF), posterior lumbar interbody fusion (PLIF), or transforaminal lumbar interbody fusion (TLIF) approach, using autograft or allograft bone graft. When used in the lumbar spine, the FULE Interbody Fusion Cage Systems are not intended for stand-alone use and must be used with supplemental fixation systems that have been cleared by FDA for use in the lumbar/lumbosacral spine, such as posterior pedicle screw and rod fixation systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253151: Fule Interbody Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253151
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026