510(k) · Cleared
ClearedStalif TT Intervertebral Body Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jun 4, 2008 as substantially equivalent to K080083 (Medtronic Sofamor Danek, 2008) and 4 other predicates after a 215-day review. Its family tree reaches back 10 generations to 1984. 1 of the 946 devices in its family, counting itself, has a Class I recall. 907 later devices descend from it.
- Decided
- Jun 4, 2008
- Review
- 215 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K841189 (1984). 38 ancestors in all. 907 later devices descend from it, 32 citing it directly. 1 of the 946 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- This deviceK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · cites it directly · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · cites it directly · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · cites it directly · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 638 of its ownK120869 Anchor-L Lumbar CageStryker Spine · 2012
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 1 generation backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- This deviceK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
Showing 5 of 907 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 907 · See all- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · cites it directly834descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · cites it directly753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · cites it directly744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · cites it directly696descendants
- K120869Anchor-L Lumbar CageStryker Spine · 2012 · cites it directly638descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −3 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −1 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| 0 (this device) | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +1 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +1 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +1 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| +1 | K120869 | Anchor-L Lumbar Cage | Stryker Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 17 | 0 |
| 2015 | 30 | 0 |
| 2016 | 49 | 0 |
| 2017 | 62 | 0 |
| 2018 | 68 | 0 |
| 2019 | 79 | 0 |
| 2020 | 94 | 0 |
| 2021 | 73 | 1 |
| 2022 | 76 | 0 |
| 2023 | 91 | 0 |
| 2024 | 94 | 0 |
| 2025 | 78 | 0 |
| 2026 | 69 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K080083 | Intrepid Spinal System Cleared while this submission was under review Summary page 1…indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: » KO080083 — Intrepid™ Spinal System Device, Medtronic Sofamor Danck, USA e KO051027, K041617 - STALIF™ TT Vertebral Body Replacement Device… | 2008 |
| * | K051027 | Stalif TTSummary page 1…composition when compared to the predicate devices cleared under the following submissions: » KO080083 — Intrepid™ Spinal System Device, Medtronic Sofamor Danck, USA e KO051027, K041617 - STALIF™ TT Vertebral Body Replacement Device, Surgicraft Limited e K072415 - STALIF™ C Intervertebral Body Fusion Devi… | 2005 |
| * | K041617 | Stalif TTSummary page 1…ion when compared to the predicate devices cleared under the following submissions: » KO080083 — Intrepid™ Spinal System Device, Medtronic Sofamor Danck, USA e KO051027, K041617 - STALIF™ TT Vertebral Body Replacement Device, Surgicraft Limited e K072415 - STALIF™ C Intervertebral Body Fusion Device, Surgi… | 2004 |
| * | K072415 | Stalif (TM) C Cleared while this submission was under review Summary page 1…sions: » KO080083 — Intrepid™ Spinal System Device, Medtronic Sofamor Danck, USA e KO051027, K041617 - STALIF™ TT Vertebral Body Replacement Device, Surgicraft Limited e K072415 - STALIF™ C Intervertebral Body Fusion Device, Surgicraft Limited e P970015, S022 — LT-Cage Lumbar Tapered Fusion Device, Medtron… | 2008 |
| * | P970015 | Inter Fix Threaded Fusion DeviceSummary page 1…USA e KO051027, K041617 - STALIF™ TT Vertebral Body Replacement Device, Surgicraft Limited e K072415 - STALIF™ C Intervertebral Body Fusion Device, Surgicraft Limited e P970015, S022 — LT-Cage Lumbar Tapered Fusion Device, Medtronic Sofamor Danek, USA Surgioraft Urnited / 16 The Oaka / Clewss Road / Redd… | 1999 |
What descends from it? (907)
See all 90732 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083475 | Lucent Magnum | 2009 | 834 |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | 2008 | 753 |
| K100043 | Coroent XLR Standalone System | 2010 | 744 |
| K123045 | Brigade Standalone System | 2013 | 696 |
| K120869 | Anchor-L Lumbar Cage | 2012 | 638 |
| K101301 | Stalif Midline | 2010 | 474 |
| K091301 | Life Spine Stand-Alone Spacer System | 2009 | 473 |
| K100802 | Aesculap Implant Systems Sibd Spinal System | 2010 | 461 |
| K133286 | Midline (TM) | 2014 | 460 |
| K092211 | Chesapeake Spinal System | 2010 | 450 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K083475 (Spinal Elements, Inc., 2009) has gone furthest, with 834 descendants of its own.
- 2 other devices also cite its predicate K080083.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The STALIF™ TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Thesc patients should be skeletally mature…
Read the full statement (144 words)
The STALIF™ TT Intervertebral Body Fusion System is indicated for use with
autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two
contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1
Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic
back pain with degeneration of the disc confirmed by history and radiographic studies.
Thesc patients should be skeletally mature and have had six months of non-operative
treatment. Patienfs with previous non-fusion spinal surgery at the treated level may be
treated. These implants may be implanted via a laparoscopic or an open anterior
approach.
The STALIF™ TT is a stand alonc system intended to be used with the bone screws
provided and requires no additional supplementary fixation systcms.
The STALIF™ TT system may be used with bone grafling material (autograft only).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K073109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073109: Stalif TT Intervertebral Body Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073109
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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