510(k) · Cleared
ClearedStalif TT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgicraft, Ltd. · MQP Spinal Vertebral Body Replacement Device
Cleared on Sep 8, 2004 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1984. 1 of the 934 devices in its family, counting itself, has a Class I recall. 929 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K841189 (1984). 4 ancestors in all. 929 later devices descend from it, 5 citing it directly. 1 of the 934 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 1 generation backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- This deviceK041617 Stalif TTSurgicraft, Ltd. · 2004
- Descendant · cites it directly · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 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 · 2 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- Descendant · 2 generations on · 696 of its ownK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
Showing 5 of 929 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 929 · See all- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · cites it directly907descendants
- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · 2 generations on834descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · cites it directly753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 2 generations on744descendants
- K123045Brigade Standalone SystemNuvasive, Inc. · 2013 · 2 generations on696descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −1 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| 0 (this device) | K041617 | Stalif TT | Surgicraft, Ltd. | 2004 | — |
| +1 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +1 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +2 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| +2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 19 | 0 |
| 2015 | 30 | 0 |
| 2016 | 50 | 0 |
| 2017 | 67 | 0 |
| 2018 | 68 | 0 |
| 2019 | 80 | 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 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? (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 |
|---|---|---|---|
| * | K990148 | Stackable Cage SystemSummary page 1…Predicate Device: DePuy AcroMed Stackable Cage T System K990148, K001340, K013382 Performance Data: Performance data were submitted. DEPARTMENT OF HE.ALTH-& HUMAN SERV… | 1999 |
| * | K001340 | Stackable Cage SystemSummary page 1…te Device: DePuy AcroMed Stackable Cage T System K990148, K001340, K013382 Performance Data: Performance data were submitted. DEPARTMENT OF HE.ALTH-& HUMAN SERVICES… | 2000 |
| * | K013382 | Modification to: Stackable Cage SystemSummary page 1…: DePuy AcroMed Stackable Cage T System K990148, K001340, K013382 Performance Data: Performance data were submitted. DEPARTMENT OF HE.ALTH-& HUMAN SERVICES… | 2001 |
What descends from it? (929)
See all 9295 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073109 | Stalif TT Intervertebral Body Fusion System | 2008 | 907 |
| K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | 2008 | 753 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K112561 | Nuvasive Coroent NO-Profile System | 2012 | 12 |
| K051069 | Nonresorbable Centraloc Tibial Screw & Washer | 2005 | 0 |
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 · 5 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 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073109 (Surgicraft, Ltd., 2008) has gone furthest, with 907 descendants of its own.
- 20 other devices also cite its predicate K990148.
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 STALIFTM TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5). The STALIFTM TT device is intended…
Read the full statement (119 words)
The STALIFTM TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIFTM TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041617: Stalif TT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041617
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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