510(k) · Cleared
ClearedRectangular Corpectomy Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 22, 2015 as substantially equivalent to K091426 (Verticor, Ltd., 2009) and 2 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Dec 22, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K841189 (1984). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 3 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 2 generations backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- 1 generation backK103320 Synthes XRLSynthes Spine Co.Lp · 2011 · Recalled
- This deviceK152460 Rectangular Corpectomy CageAmendia, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −3 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −2 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| −1 | K103320 | Synthes XRL | Synthes Spine Co.Lp | 2011 | 1 |
| 0 (this device) | K152460 | Rectangular Corpectomy Cage | Amendia, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K091426 | Cervicore Corpectomy CageSummary page 4…cation: MQP, 888.3060, Class II, Spinal Vertebral Body Replacement Device Primary Predicate Device: Samson Corpectomy Cage (K091426) Additional Predicate Devices: Synthes XRL System (K103320) Phenix™ VBR (K072029)… | 2009 |
| * | K103320 | Synthes XRLSummary page 4…acement Device Primary Predicate Device: Samson Corpectomy Cage (K091426) Additional Predicate Devices: Synthes XRL System (K103320) Phenix™ VBR (K072029) Purpose of Submission: This traditional 510(k) is seeking clearanc… | 2011 |
| * | K072029 | Phenix Vertebral Body ReplacementSummary page 4…e Device: Samson Corpectomy Cage (K091426) Additional Predicate Devices: Synthes XRL System (K103320) Phenix™ VBR (K072029) Purpose of Submission: This traditional 510(k) is seeking clearance for modifications to the Samson Corpectomy Cage, includin… | 2007 |
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 31 years and passes through 5 companies; a new generation was cleared every 10.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K091426.
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. 2015, 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?
The Rectangular Corpectomy Cage is a vertebral body replacement system 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 T1 to L5). The Rectangular Corpectomy Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152460: Rectangular Corpectomy Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152460
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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