510(k) · Cleared
Recalled · Class I · 2012Graftcage TLX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 16, 2005 as substantially equivalent to K011037 (Synthes (Usa), 2002) and 2 other predicates after a 168-day review. Its family tree reaches back 7 generations to 2001. 1 of the 20 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Dec 16, 2005
- Review
- 168 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003155 (2001). 19 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 6 generations backK012254 VBROsteotech, Inc. · 2001
- 5 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 4 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 3 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 2 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 1 generation backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- This deviceK051781 Graftcage TLXOsteotech, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −6 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −5 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −4 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −3 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −2 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −1 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| 0 (this device) | K051781 | Graftcage TLX | Osteotech, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K011037 | Vertebral Spacer | 2002 |
| * | K010530 | Geo StructureSummary page 1…me GraftCage TLX *Interpore Cross's GEO Structure, K010530, cleared August 3, 2001; and · Stryker Spine's AVS TL Sp… | 2001 |
| * | K042571 | Stryker Spine Avs TL Peek SpacerSummary page 1…· Stryker Spine's AVS TL Spacer, K042571 cleared February 11, 2005. Common Name Vertebral Body Replacement Device I Classificati… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2012 | Class I | Z-1931-2012 | Process design | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 1 of the 19 ancestors has a recall of any class.
- 10 other devices also cite its predicate K011037.
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 GraftCageTM TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI -L5). The Graftcage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The GraftCage…
Read the full statement (128 words)
The GraftCageTM TLX is a vertebral body replacement device intended to replace a collapsed, damaged, or unstable vertebral body in the thoracic or lumbar spine (TI -L5). The Graftcage TLX is indicated for a partial or total vertebrectomy for cases of tumor or trauma (i.e., fracture). The GraftCage TLX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
The GraftCage TLX is intended for use with supplemental internal spinal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. These systems include posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the GraftCage TLX is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051781: Graftcage TLX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051781
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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