510(k) · Cleared
ClearedNubic and Rabea Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 24, 2009 after a 298-day review. The FDA summary names no predicate by number. 74 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 298 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 0
74 later devices descend from it, 5 citing it directly.
- This deviceK082848 Nubic and Rabea DevicesSignus Medizintechnik GmbH · 2009
- Descendant · cites it directly · 31 of its ownK111983 Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011
- Descendant · 2 generations on · 29 of its ownK133784 Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014
- Descendant · cites it directly · 23 of its ownK110915 Cervical CageEisertech, LLC · 2011
- Descendant · 2 generations on · 22 of its ownK122444 Cervical CageEisertech, LLC · 2012
- Descendant · cites it directly · 20 of its ownK111820 Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology · 2011 · cites it directly31descendants
- K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology · 2014 · 2 generations on29descendants
- K110915Cervical CageEisertech, LLC · 2011 · cites it directly23descendants
- K122444Cervical CageEisertech, LLC · 2012 · 2 generations on22descendants
- K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd. · 2012 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082848 | Nubic and Rabea Devices | Signus Medizintechnik GmbH | 2009 | — |
| +1 | K111983 | Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx | Zimmer Trabecular Metal Technology | 2011 | — |
| +2 | K133784 | Vista-S Device, Associated Instrumentation | Zimmer Trabecular Metal Technology | 2014 | — |
| +1 | K110915 | Cervical Cage | Eisertech, LLC | 2011 | — |
| +2 | K122444 | Cervical Cage | Eisertech, LLC | 2012 | — |
| +1 | K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | Bm Korea Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 9 | 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 ODP? 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?
The FDA summary names no predicate by number.
What descends from it? (74)
See all 745 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111983 (Zimmer Trabecular Metal Technology, 2011) has gone furthest, with 31 descendants of its own.
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. 2009, 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?
When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft. When used as…
Read the full statement (375 words)
When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to TI, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA or TOSCA II anterior cervical plate systems if desired.
When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.
When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to Ti, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082848: Nubic and Rabea Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082848
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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