510(k) Report

510(k) · Cleared

Cleared

Arx Spinal System

K051525510(k) TraditionalCleared Feb 17, 2006254-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Amedica Corp. · MQP Spinal Vertebral Body Replacement Device

Cleared on Feb 17, 2006 after a 254-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided
Feb 17, 2006
Review
254 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared20052010201520202025
  1. This deviceK051525 Arx Spinal SystemAmedica Corp. · 2006
  2. Descendant · cites it directly · 1 of its ownK073125 Valeo VBRAmedica Corp. · 2007
  3. Descendant · cites it directly · 0 of its ownK073505 Modification to Valeo VBRAmedica Corp. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K073125Valeo VBRAmedica Corp. · 2007 · cites it directly1descendant
  • K073505Modification to Valeo VBRAmedica Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051525Arx Spinal SystemAmedica Corp.2006—
+1K073125Valeo VBRAmedica Corp.2007—
+1K073505Modification to Valeo VBRAmedica Corp.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
FIG. 1 — Lineage of K051525, 2006–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Medtronic Sofamor Danek Spinal Mesh
Named without a submission number
—
*—Synthes Vertebral Spacer System
Named without a submission number
—
*—Hedrocel Vertebral Body Replacement
Named without a submission number
—
*—Scient'x Ellys and Aurys VBR
Named without a submission number
—
*—DePuy Acromed VBR System
Named without a submission number
—
*—DePuy Acromed Surgical Titanium Mesh System
Named without a submission number
—
*—DePuy Acromed Stackable Cage System
Named without a submission number
—
*—EBI Ionic Spine Spacer System
Named without a submission number
—
*—Medtronic Sofamor Danek VERTE-STACK Spinal System
Named without a submission number
—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073125Valeo VBRAmedica Corp.20071
K073505Modification to Valeo VBRAmedica Corp.20080

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?

  • Of its descendants, K073125 (Amedica Corp., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore…

Read the full statement (138 words)

The ARX Spinal System is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The ARX Spinal System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The ARX Spinal System is always to be used with supplemental internal spinal fixation.

Additionally, the ARX Spinal System may be used with bone graft.

Indications for use as stated in the FDA summary.

More from Amedica Corp.

16 FDA decisions under this applicant name. See the company

  • K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp. · 2018
  • K161405Valeo II Interbody Fusion Device SystemAmedica Corp. · 2016
  • K143518Valeo Spacer System and Valeo II Interbody Fusion Device SystemAmedica Corp. · 2015
  • K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
  • K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K051525 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051525: Arx Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051525

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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