510(k) · Cleared
ClearedTetris II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 29, 2012 as substantially equivalent to K022793 (Signus Medical, LLC, 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 7 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 29, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K010530 (2001). 23 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 6 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 5 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 4 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 3 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 2 generations backK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- 1 generation backK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- This deviceK122317 Tetris IISignus Medizintechnik GmbH · 2012
- Descendant · cites it directly · 0 of its ownK241438 Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH · 2024
- Descendant · cites it directly · 0 of its ownK181899 Roccia® PlifSilony Medical GmbH · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −6 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −5 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −4 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −3 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −2 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| −1 | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| 0 (this device) | K122317 | Tetris II | Signus Medizintechnik GmbH | 2012 | — |
| +1 | K241438 | Signus Tetris™ St; Signus Tetris™ R St | Signus Medizintechnik GmbH | 2024 | — |
| +1 | K181899 | Roccia® Plif | Silony Medical GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
Planning a device in MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K022793 | Tetris Spinal ImplantSummary page 1…l marker pins used in the PEEK devices are manufactured from tantalum as described by ASTMV F560. Predicate Devices: Titanium TETRI STM (K022793) PEEK TETR ISTM (K031 757) PEEK and Titanium,TETRIS TM (Ki111792)… | 2003 |
| * | K031757 | Peek Tetris Spinal ImplantSummary page 1…red from tantalum as described by ASTMV F560. Predicate Devices: Titanium TETRI STM (K022793) PEEK TETR ISTM (K031 757) PEEK and Titanium,TETRIS TM (Ki111792)… | 2003 |
| * | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSummary page 1…60. Predicate Devices: Titanium TETRI STM (K022793) PEEK TETR ISTM (K031 757) PEEK and Titanium,TETRIS TM (Ki111792) Page 14… | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K241438 (Signus Medizintechnik GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K022793.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as a vertebral body replacement, the TETRI STM 11 devices are 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. When used as an intervertebral fusion device, the TETRIS~m 11devices are intended for use at one level in…
Read the full statement (154 words)
When used as a vertebral body replacement, the TETRI STM 11 devices are 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.
When used as an intervertebral fusion device, the TETRIS~m 11devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDID is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122317: Tetris II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122317
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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