510(k) · Cleared
ClearedTasmin R
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 Jan 14, 2014 as substantially equivalent to K031757 (Signus Medical, LLC, 2003) and 6 other predicates after a 403-day review. Its family tree reaches back 12 generations to 1984. 1 later device descends from it.
- Decided
- Jan 14, 2014
- Review
- 403 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K841189 (1984). 69 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK123758 Tasmin RSignus Medizintechnik GmbH · 2014
- Descendant · cites it directly · 0 of its ownK241438 Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH · 2024
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK120368 Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- This deviceK123758 Tasmin RSignus Medizintechnik GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −1 | K120368 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| 0 (this device) | K123758 | Tasmin R | Signus Medizintechnik GmbH | 2014 | — |
| +1 | K241438 | Signus Tetris™ St; Signus Tetris™ R St | Signus Medizintechnik GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MQP? 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? (7)
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 2…K1 23758 Page 2of 2 Predicate Devices: PEEK TETRIS TM (SIGNUS - K031757, K1 11792) MC+ (LDR Spine USA - K043479) Hourglass (Medtronic Sofamor Danek - K033926)… | 2003 |
| * | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSummary page 2…K1 23758 Page 2of 2 Predicate Devices: PEEK TETRIS TM (SIGNUS - K031757, K1 11792) MC+ (LDR Spine USA - K043479) Hourglass (Medtronic Sofamor Danek - K033926)… | 2012 |
| * | K043479 | MC+ Partial VBRSummary page 2…Page 2of 2 Predicate Devices: PEEK TETRIS TM (SIGNUS - K031757, K1 11792) MC+ (LDR Spine USA - K043479) Hourglass (Medtronic Sofamor Danek - K033926) Ray TFC (Surgical Dynamics - P950019)… | 2005 |
| * | K033926 | Hourglass Vertebral Body SpacerSummary page 2…icate Devices: PEEK TETRIS TM (SIGNUS - K031757, K1 11792) MC+ (LDR Spine USA - K043479) Hourglass (Medtronic Sofamor Danek - K033926) Ray TFC (Surgical Dynamics - P950019) CoRoent® (NuVasive Inc. - K071 795)… | 2004 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…) MC+ (LDR Spine USA - K043479) Hourglass (Medtronic Sofamor Danek - K033926) Ray TFC (Surgical Dynamics - P950019) CoRoent® (NuVasive Inc. - K071 795) Capstone Control (Medtronic Sofamor Danek - K1 203… | 1996 |
| * | K071795 | Nuvasive Coroent SystemSummary page 2…Hourglass (Medtronic Sofamor Danek - K033926) Ray TFC (Surgical Dynamics - P950019) CoRoent® (NuVasive Inc. - K071 795) Capstone Control (Medtronic Sofamor Danek - K1 20368) Performance Data: Finite element analysis simulati… | 2007 |
| * | K120368 | Capstone Control Spinal SystemSummary page 2…Ray TFC (Surgical Dynamics - P950019) CoRoent® (NuVasive Inc. - K071 795) Capstone Control (Medtronic Sofamor Danek - K1 20368) Performance Data: Finite element analysis simulations of the worst case TETRISTM and TASMIN® R devices w… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241438 | Signus Tetris™ St; Signus Tetris™ R St | 2024 | 0 |
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 30 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 69 ancestors have a recall of any class.
- Of its descendants, K241438 (Signus Medizintechnik GmbH, 2024) has gone furthest, with 0 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. 2014, this device’s year, is highlighted.
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?
When used as a vertebral body replacement, the TASMIN® R 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 TASMINO R devices are intended for use at one level in the…
Read the full statement (154 words)
When used as a vertebral body replacement, the TASMIN® R 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 TASMINO R devices are intended for use at one level in the lumbar spine, from L2 to Si, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD 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/K123758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123758: Tasmin R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123758
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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