510(k) · Cleared
ClearedGraftcage Acx
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 1, 2005 as substantially equivalent to K012254 (Osteotech, Inc., 2001) and 3 other predicates after a 29-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Dec 1, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K841189 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 2 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 1 generation backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- This deviceK053080 Graftcage AcxOsteotech, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −2 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −1 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| 0 (this device) | K053080 | Graftcage Acx | Osteotech, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012254 | VBRSummary page 2…material with the GraftCage TM ACX is optional. Comparison to Predicate: The GraftCage"" ACX claims substantial equivalence to: I) Osteotech, Inc. VBR, K012254 2) DePuy AcroMed VBR System, K030833/K031635; 3) Spinal Concepts Fortitude Vue Vertebral Body Repla… | 2001 |
| * | K030833 | Depuy Acromed VBR SystemSummary page 2…mparison to Predicate: The GraftCage"" ACX claims substantial equivalence to: I) Osteotech, Inc. VBR, K012254 2) DePuy AcroMed VBR System, K030833/K031635; 3) Spinal Concepts Fortitude Vue Vertebral Body Replacement Device, K05 100; and 4) Implex… | 2003 |
| * | K031635 | Depuy Acromed VBR SystemSummary page 2…to Predicate: The GraftCage"" ACX claims substantial equivalence to: I) Osteotech, Inc. VBR, K012254 2) DePuy AcroMed VBR System, K030833/K031635; 3) Spinal Concepts Fortitude Vue Vertebral Body Replacement Device, K05 100; and 4) Implex Corpora… | 2003 |
| Kept off the family tree | K051000 | FDA’s K051000 is Fortitude Vue Vertebral Body Replacement Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K010378 | Hedrocel Vertebral Body Replacement, Model XX-Yyy-ZZZZSummary page 2…3) Spinal Concepts Fortitude Vue Vertebral Body Replacement Device, K05 100; and 4) Implex Corporation Hedrocel Vertebral Body Replacement System, K010378. This claim of substantial equivalence is intended to reflect FDA's definition of substantial equivalence as defined by 21 CFR P… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 12 ancestors has a recall.
- 17 other devices also cite its predicate K012254.
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 GraftCage TM ACX 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 GraftCageTM ACX is indicated for a partial or total vertebrectormy for cases of tumor or trauma (i.e., fracture). The GraftCage TM ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The…
Read the full statement (130 words)
The GraftCage TM ACX 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 GraftCageTM ACX is indicated for a partial or total vertebrectormy for cases of tumor or trauma (i.e., fracture). The GraftCage TM ACX is intended to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body.
The GraftCageTM ACX 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' TM ACX is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053080: Graftcage Acx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053080
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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