510(k) · Cleared
ClearedCurved Peek Tetris 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 Aug 10, 2004 as substantially equivalent to K031757 (Signus Medical, LLC, 2003) after a 29-day review. Its family tree reaches back 5 generations to 1984. 1 of the 1,593 devices in its family, counting itself, has a Class I recall. 1,586 later devices descend from it.
- Decided
- Aug 10, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K841189 (1984). 6 ancestors in all. 1,586 later devices descend from it, 11 citing it directly. 1 of the 1,593 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 2 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- This deviceK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- Descendant · cites it directly · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · 2 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 3 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 4 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 5 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
Showing 5 of 1,586 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 1,586 · See all- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · cites it directly1,440descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 5 generations on1,008descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −2 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| 0 (this device) | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| +1 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +5 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 14 | 0 |
| 2008 | 19 | 0 |
| 2009 | 7 | 0 |
| 2010 | 19 | 0 |
| 2011 | 40 | 0 |
| 2012 | 43 | 0 |
| 2013 | 56 | 0 |
| 2014 | 80 | 0 |
| 2015 | 74 | 0 |
| 2016 | 97 | 0 |
| 2017 | 118 | 0 |
| 2018 | 112 | 0 |
| 2019 | 117 | 0 |
| 2020 | 109 | 0 |
| 2021 | 105 | 1 |
| 2022 | 104 | 0 |
| 2023 | 136 | 0 |
| 2024 | 127 | 0 |
| 2025 | 102 | 0 |
| 2026 | 91 | 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 |
|---|---|---|---|
| * | K031757 | Peek Tetris Spinal ImplantSummary page 1…Name: Curved PEEK TetrisTm Classification 21 CFR 888.3060 Name and Number: Product Code: MQP Predicate Device PEEK Tetris Tm cleared under K031757 on 7/30/03. Device Description: The Curved PEEK Tetris® Spinal implant is a hollow, slightly curved frame… | 2003 |
What descends from it? (1,586)
See all 1,58611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042930 | Spacevision Cage System | 2004 | 1,440 |
| K043316 | Rabea Spinal Implant | 2005 | 1,005 |
| K051659 | Semial Spinal Implant | 2005 | 790 |
| K060762 | Aesculap Peek Vertebral Body Replacement System | 2006 | 789 |
| K050058 | Theken Reveal VBR System | 2005 | 727 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K043349 | Open Radiotransparent Intersomatic Implant (Roi) | 2005 | 134 |
| K070218 | Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR) | 2007 | 60 |
| K052533 | Kimba Spinal Implant | 2005 | 41 |
| K070381 | Theken VU Mesh VBR System | 2007 | 25 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K042930 (Spine Vision, Inc., 2004) has gone furthest, with 1,440 descendants of its own.
- 12 other devices also cite its predicate K031757.
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 Curved PEEK Tetris Tm 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. The Curved PEEK Tetris ir: may be implanted singularly or in pairs. The supplemental internal fixation systems that may be used with…
Read the full statement (118 words)
The Curved PEEK Tetris Tm 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.
The Curved PEEK Tetris ir: may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the Curved PEEK TetrisTh Spinal Implant is the same as the Curved PEEK Tetris 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/K041888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041888: Curved Peek Tetris Spinal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041888
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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