510(k) · Cleared
ClearedPeek Tetris Spinal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medical, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 30, 2003 as substantially equivalent to K022793 (Signus Medical, LLC, 2003) after a 54-day review. Its family tree reaches back 4 generations to 1984. 1 of the 1,708 devices in its family, counting itself, has a Class I recall. 1,702 later devices descend from it.
- Decided
- Jul 30, 2003
- Review
- 54 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K841189 (1984). 5 ancestors in all. 1,702 later devices descend from it, 13 citing it directly. 1 of the 1,708 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 2 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 1 generation backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- This deviceK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- Descendant · cites it directly · 1,586 of its ownK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- Descendant · 2 generations on · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · 3 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 4 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · cites it directly · 1,218 of its ownK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
Showing 5 of 1,702 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 1,702 · See all- K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004 · cites it directly1,586descendants
- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · 2 generations on1,440descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 4 generations on1,405descendants
- K033109Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004 · cites it directly1,218descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −3 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −2 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −1 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| 0 (this device) | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| +1 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| +2 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +1 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
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 | 4 | 0 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 14 | 0 |
| 2008 | 22 | 0 |
| 2009 | 12 | 0 |
| 2010 | 23 | 0 |
| 2011 | 51 | 0 |
| 2012 | 55 | 0 |
| 2013 | 68 | 0 |
| 2014 | 92 | 0 |
| 2015 | 86 | 0 |
| 2016 | 104 | 0 |
| 2017 | 130 | 0 |
| 2018 | 117 | 0 |
| 2019 | 122 | 0 |
| 2020 | 109 | 0 |
| 2021 | 106 | 1 |
| 2022 | 106 | 0 |
| 2023 | 140 | 0 |
| 2024 | 127 | 0 |
| 2025 | 102 | 0 |
| 2026 | 92 | 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 |
|---|---|---|---|
| * | K022793 | Tetris Spinal Implant | 2003 |
What descends from it? (1,702)
See all 1,70213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041888 | Curved Peek Tetris Spinal Implant | 2004 | 1,586 |
| K033109 | Ellys and Aurys Vertebral Body Replacements | 2004 | 1,218 |
| K060762 | Aesculap Peek Vertebral Body Replacement System | 2006 | 789 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K062151 | Box Peek VBR System | 2006 | 175 |
| K043349 | Open Radiotransparent Intersomatic Implant (Roi) | 2005 | 134 |
| K052533 | Kimba Spinal Implant | 2005 | 41 |
| K070381 | Theken VU Mesh VBR System | 2007 | 25 |
| K052670 | Staxx XD System | 2006 | 8 |
| K122317 | Tetris II | 2012 | 2 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K041888 (Signus Medizintechnik GmbH, 2004) has gone furthest, with 1,586 descendants of its own.
- 5 other devices also cite its predicate K022793.
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 PEEK TetrisTM 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 T1 to L5).
The PEEK TetrisTM Spinal Implant is intended for use with Supplemental internal fixation.
The supplemental internal fixation systems that may be used with ithe PEEK TetrisTM Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, MOSS, T i m, and Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031757: 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/K031757
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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