510(k) · Cleared
ClearedBEE HA
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 Nov 21, 2025 as substantially equivalent to K203444 (NGMedical GmbH, 2021) and 2 other predicates after a 269-day review. Its family tree reaches back 18 generations to 2001. 1 of the 246 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 21, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 245 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 246 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- 2 generations backK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
- 1 generation backK203444 BEE HA CageNGMedical GmbH · 2021
- This deviceK250560 BEE HANGMedical GmbH · 2025
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 12 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 11 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 10 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 9 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 8 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 7 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 6 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 5 generations backK121649 Construx Mini Peek TI Spacer SystemOrthofix · 2012
- 4 generations backK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- 3 generations backK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
- 2 generations backK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
- 1 generation backK203444 BEE HA CageNGMedical GmbH · 2021
- This deviceK250560 BEE HANGMedical GmbH · 2025
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −12 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −11 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −8 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −7 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −6 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −5 | K121649 | Construx Mini Peek TI Spacer System | Orthofix | 2012 | — |
| −4 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| −3 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
| −2 | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | 2018 | — |
| −1 | K203444 | BEE HA Cage | NGMedical GmbH | 2021 | — |
| 0 (this device) | K250560 | BEE HA | NGMedical GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 14 | 0 |
| 2004 | 25 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 17 | 0 |
| 2008 | 29 | 1 |
| 2009 | 22 | 0 |
| 2010 | 11 | 0 |
| 2011 | 20 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K203444 | BEE HA CageSummary page 6…ubstantial Equivalence: The subject components are substantially equivalent to the following predicate devices: Primary Predicate: BEE HA Cage, NGMedical GmbH, K203444 Additional Predicate: BEE Cervical Cage, NGMedical GmbH, K231371 PATRIOT® COLONIAL® Spacer, Globus Medical Inc.… | 2021 |
| * | K231371 | BEE Cervical CageSummary page 6…to the following predicate devices: Primary Predicate: BEE HA Cage, NGMedical GmbH, K203444 Additional Predicate: BEE Cervical Cage, NGMedical GmbH, K231371 PATRIOT® COLONIAL® Spacer, Globus Medical Inc., K173722 The subject components indications, technological characteristic… | 2024 |
| * | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN SpacerSummary page 6…BEE HA Cage, NGMedical GmbH, K203444 Additional Predicate: BEE Cervical Cage, NGMedical GmbH, K231371 PATRIOT® COLONIAL® Spacer, Globus Medical Inc., K173722 The subject components indications, technological characteristics and materials are identical to the primary predicate. The addi… | 2018 |
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 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 30 of the 245 ancestors have a recall of any class; 1 has a Class I recall.
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. 2025, 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 HA 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 more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA 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/K250560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250560: BEE HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250560
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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