510(k) · Cleared
ClearedBEE Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NGMedical GmbH · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 29, 2021 as substantially equivalent to K170503 (Eit Emerging Implant Technologies GmbH, 2017) after a 343-day review. Its family tree reaches back 16 generations to 1984. 1 of the 130 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Jan 29, 2021
- Review
- 343 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K841189 (1984). 118 ancestors in all. 11 later devices descend from it, 5 citing it directly. 1 of the 130 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 1 generation backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- This deviceK200429 BEE CagesNGMedical GmbH · 2021
- Descendant · cites it directly · 4 of its ownK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · cites it directly · 1 of its ownK231252 Ventana™ L Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK211413 BEE PLIF CageNGMedical GmbH · 2021
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 5 generations backK103169 AleuttianK2m, Inc. · 2011
- 4 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 2 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 1 generation backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- This deviceK200429 BEE CagesNGMedical GmbH · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
Most influential descendants
Showing 5 of 11 · See all- K222833Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023 · cites it directly4descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on2descendants
- K231252Ventana™ L Spinal SystemSpinal Elements, Inc. · 2023 · cites it directly1descendant
- K211413BEE PLIF CageNGMedical GmbH · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −8 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −7 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −6 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −5 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −4 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −3 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −2 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| −1 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| 0 (this device) | K200429 | BEE Cages | NGMedical GmbH | 2021 | — |
| +1 | K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023 | — |
| +2 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +1 | K231252 | Ventana™ L Spinal System | Spinal Elements, Inc. | 2023 | — |
| +1 | K211413 | BEE PLIF Cage | NGMedical GmbH | 2021 | — |
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 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 1 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Summary page 4…80 Device Panel Orthopedic Primary Predicate EIT Cellular Titanium® Cervical Cage - EIT Emerging Implant Technologies GmbH Device (K170503) Reference Predicate Crystal® - Spinal Elements, Inc. (K073351) Devices The BEE Cervical Cage is… | 2017 |
| † | K073351 | Crystal | 2008 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 37 years and passes through 11 companies; a new generation was cleared every 1.6 years on median.
- 17 of the 118 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222833 (Spinal Elements, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 15 other devices also cite its predicate K170503.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200429: BEE Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200429
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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