510(k) · Cleared
ClearedBEE PLIF Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NGMedical GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 30, 2026 as substantially equivalent to K211413 (NGMedical GmbH, 2021) and 2 other predicates after a 29-day review. Its family tree reaches back 24 generations to 1984. 1 of the 218 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 30, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 24 generations to K841189 (1984). 217 ancestors in all. No later device cites it as a predicate yet. 1 of the 218 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- 2 generations backK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- 1 generation backK211413 BEE PLIF CageNGMedical GmbH · 2021
- This deviceK261067 BEE PLIF CageNGMedical GmbH · 2026
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160955 Tritanium® PL CageStryker · 2016
- 4 generations backK181014 Tritanium PL CageStryker Spine · 2018
- 3 generations backK183447 EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH · 2019
- 2 generations backK201605 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF…Eit Emerging Implant Technologies GmbH · 2020
- 1 generation backK211413 BEE PLIF CageNGMedical GmbH · 2021
- This deviceK261067 BEE PLIF CageNGMedical GmbH · 2026
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −4 | K181014 | Tritanium PL Cage | Stryker Spine | 2018 | — |
| −3 | K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019 | — |
| −2 | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT… | Eit Emerging Implant Technologies GmbH | 2020 | — |
| −1 | K211413 | BEE PLIF Cage | NGMedical GmbH | 2021 | — |
| 0 (this device) | K261067 | BEE PLIF Cage | NGMedical GmbH | 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 | 15 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 32 | 1 |
| 2009 | 20 | 0 |
| 2010 | 9 | 0 |
| 2011 | 16 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K211413 | BEE PLIF CageSummary page 6…mbar spine. Substantial Equivalence: The subject device is substantially equivalent to the following predicate devices: Primary Predicate: NG Medical – BEE PLIF Cages – K211413 Additional Predicate: EIT Emerging Implant Technologies GmbH – EIT Cellular Titanium® PLIF Cages – K170503, K201605 The subject… | 2021 |
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 6…ate devices: Primary Predicate: NG Medical – BEE PLIF Cages – K211413 Additional Predicate: EIT Emerging Implant Technologies GmbH – EIT Cellular Titanium® PLIF Cages – K170503, K201605 The subject and primary predicate device are identical in Intended Use,. The subject device is similar to the predicate… | 2017 |
| * | K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Summary page 6…es: Primary Predicate: NG Medical – BEE PLIF Cages – K211413 Additional Predicate: EIT Emerging Implant Technologies GmbH – EIT Cellular Titanium® PLIF Cages – K170503, K201605 The subject and primary predicate device are identical in Intended Use,. The subject device is similar to the predicate devices… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 15 companies; a new generation was cleared every 11 months on median.
- 25 of the 217 ancestors have a recall of any class; 1 has a Class I recall.
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?
BEE® PLIF cages and NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six…
Read the full statement (139 words)
BEE® PLIF cages and NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261067: BEE PLIF Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261067
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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