510(k) · Cleared
ClearedRabea Spinal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 7, 2005 as substantially equivalent to K041888 (Signus Medizintechnik GmbH, 2004) after a 67-day review. Its family tree reaches back 6 generations to 1984. 1 of the 1,013 devices in its family, counting itself, has a Class I recall. 1,005 later devices descend from it.
- Decided
- Feb 7, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 7 ancestors in all. 1,005 later devices descend from it, 5 citing it directly. 1 of the 1,013 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- This deviceK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- Descendant · cites it directly · 834 of its ownK051246 Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005
- Descendant · cites it directly · 790 of its ownK052096 Nubic Spinal ImplantSignus Medical, LLC · 2005
- Descendant · cites it directly · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- Descendant · 2 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 754 of its ownK060350 Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006
Showing 5 of 1,005 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 1,005 · See all- K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc. · 2005 · cites it directly834descendants
- K052096Nubic Spinal ImplantSignus Medical, LLC · 2005 · cites it directly790descendants
- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · cites it directly789descendants
- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 2 generations on788descendants
- K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc. · 2006 · 2 generations on754descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| +1 | K051246 | Construx Mini Peek VBR System | Blackstone Medical, Inc. | 2005 | — |
| +1 | K052096 | Nubic Spinal Implant | Signus Medical, LLC | 2005 | — |
| +1 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| +2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +2 | K060350 | Construx PL/TL Peek Partial VBR System | Blackstone Medical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 10 | 0 |
| 2013 | 14 | 0 |
| 2014 | 28 | 0 |
| 2015 | 33 | 0 |
| 2016 | 56 | 0 |
| 2017 | 81 | 0 |
| 2018 | 72 | 0 |
| 2019 | 87 | 0 |
| 2020 | 95 | 0 |
| 2021 | 79 | 1 |
| 2022 | 80 | 0 |
| 2023 | 95 | 0 |
| 2024 | 96 | 0 |
| 2025 | 80 | 0 |
| 2026 | 73 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K041888 | Curved Peek Tetris Spinal ImplantSummary page 1…Trade Name: RAB~EA` Classificati-on 21 CFR 888.3060 Name and Number: Product Code: MQP Predicate Device Curved PEEK Tetri STM cleared under K041888 on 8/10/04. Device Description: The RABEA TM Spinal implant is a rectangular frame. The upper and lower a… | 2004 |
What descends from it? (1,005)
See all 1,0055 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K051246 (Blackstone Medical, Inc., 2005) has gone furthest, with 834 descendants of its own.
- 10 other devices also cite its predicate K041888.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The RABEATM Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental internal fixation. This device is intended to be implanted in pairs.
The supplemental internal fixation systems that may be used with the RABEATM Spinal Implant are the same as the Curved PEEK TetrisTM Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043316: Rabea Spinal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043316
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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