510(k) Report

510(k) · Cleared

Cleared

Arcuate Vertebral Augmentation System

K070527510(k) TraditionalCleared May 4, 200770-day reviewClass II21 CFR 888.3027

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

Medtronic Sofamor Danek · NDN Cement, Bone, Vertebroplasty

Cleared on May 4, 2007 as substantially equivalent to K063248 (Medtronic Sofamor Danek, 2007) and 5 other predicates after a 70-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.

Decided
May 4, 2007
Review
70 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K002652 (2001). 18 ancestors in all, the oldest K890925 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2004: 2 other ancestors2005: 2 other ancestors2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1989: 1 other ancestor2012: 1 descendant clearedReference device: K042415 · Mendec Spine · Tecres S.P.A. · 2005K002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled×2: 2 generations cleared close together, K033801 (2004), K041584 (2004) K042691 · Vertefix Vertebroplasty Procedure Set · Cook, Inc. · 2005×2: 2 generations cleared close together, K060300 (2006), K062424 (2006) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 4 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K062424 · Confidence EX High Viscosity Bone Cement · Disc-O-Tech Medical Technologies, Ltd. · 2006K060300 · Confidence High Viscosity Bone Cement · Disc-O-Tech Medical Technologies, Ltd. · 2006 · recalledK042691 · Vertefix Vertebroplasty Procedure Set · Cook, Inc. · 2005K041584 · Kyphx HV-R Bone Cement, Model C01A · Kyphon, Inc. · 2004 · recalledK033801 · Kyphx HV-R, Model C01A · Kyphon, Inc. · 2004 · recalledK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled−50
  1. Root · 6 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
  2. 5 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
  3. 4 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
  4. 3 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
  5. 2 generations backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
  6. 1 generation backK062424 Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
  7. This deviceK070527 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
  8. Descendant · cites it directly · 0 of its ownK113452 Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K002652Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp.20011
−5K033801Kyphx HV-R, Model C01AKyphon, Inc.20042
−4K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042
−3K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005—
−2K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20068
−1K062424Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.2006—
0 (this device)K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek2007—
+1K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199910
200110
200210
200310
200420
200520
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K070527, 2001–2012Source: 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 NDN? 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 NDN device

  1. #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 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? (6)

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
*K063248Arcuate Vertebral Augmentation System
Cleared while this submission was under review
Summary page 1
…se of Application The purpose of this application is to include additional instruments to the previously cleared ARCUATE TM Vertebral Augmentation System (K063248). The ARCUATE TM Vertebral Augmentation System consists of a variety of manual instruments which provides physicians…
Medtronic Sofamor Danek2007—
*K040483Equestra Fluid Delivery System
Summary page 1
…equivalent to previously cleared systems such as the ARCUATETM Vertebral Augmentation System (K063248, SE 03/13/07, the EQUESTRA TM Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System…
Medtronic Sofamor Danek, Inc.2004—
*K062452Kit Mendec Spine and Delivery System
Summary page 1
…Augmentation System (K063248, SE 03/13/07, the EQUESTRA TM Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K0…
Tecres S.P.A.2006—
*K060148Ebi Vertebroplasty Systems
Summary page 1
…Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Ce…
Ebi, L.P.2006—
*K042691Vertefix Vertebroplasty Procedure Set
Summary page 1
…e and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Cement System (K062424, SE 0914/06). The VISIOPLASTTM Spine Cement packaged…
Cook, Inc.2005—
*K062424Confidence EX High Viscosity Bone Cement
Summary page 1
…tebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Cement System (K062424, SE 0914/06). The VISIOPLASTTM Spine Cement packaged with this system was cleared by the agency for use in the tr…
Disc-O-Tech Medical Technologies, Ltd.2006—
†K042415Mendec SpineTecres S.P.A.2005—

Also cleared against K063248: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120

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 6 years and passes through 5 companies; a new generation was cleared every 8 months on median.
  • 6 of the 18 ancestors have a recall of any class.
  • Of its descendants, K113452 (Ascendx Spine, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K063248.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NDN

2in 2025

2007: 92008: 12009: 62010: 52011: 112012: 72013: 72014: 72015: 62016: 42017: 52018: 32019: 22020: 42021: 22022: 22023: 22024: 32025: 22026 (partial year): 1
2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007: 128 days median2009: 211 days median2010: 215 days median2011: 164 days median2012: 90 days median2013: 118 days median2014: 106 days median2015: 76 days median2016: 154 days median2017: 125 days median2018: 111 days median2020: 157 days median2024: 90 days median
2007high 215 (2010) · low 76 (2015)2026

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

Recalls per year · NDN

4in 2013

2009: 12013: 4
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · NDN

626in 2025

2007: 212008: 392009: 702010: 3962011: 982012: 892013: 2422014: 2312015: 2042016: 1822017: 1912018: 1442019: 2272020: 2122021: 3442022: 2702023: 3112024: 4542025: 626
2007high 626 (2025) · low 21 (2007)2025

MAUDE reports naming product code NDN, 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
20079128021
20081—039
20096211170
201052150396
201111164098
2012790089
201371184242
201471060231
20156760204
201641540182
201751250191
201831110144
20192—0227
202041570212
20212—0344
20222—0270
20232—0311
20243900454
20252—0626
20261—0—

What is it indicated for?

The ARCUATE™ Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma.

Indications for use as stated in the FDA summary.

Also cleared against K063248

2 other devices cite the same predicate.

  • K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc. · 2007
  • K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

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  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

Recent decisions in NDN

The NDN category page

  • K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed, Ltd. · 2026
  • K250637VCFix Spinal SystemAmber Implants · 2025
  • K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed, Ltd. · 2025
  • K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd. · 2024
  • K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd. · 2024

https://510kreport.com/device/K070527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070527: Arcuate Vertebral Augmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070527

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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