510(k) Report

510(k) · Cleared

Cleared

Vertefix Vertebroplasty Procedure Set

K042691510(k) TraditionalCleared Nov 8, 2005405-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

Cook, Inc. · NDN Cement, Bone, Vertebroplasty

Cleared on Nov 8, 2005 as substantially equivalent to K032945 (Stryker Corp., 2004) and 1 other predicate after a 405-day review. Its family tree reaches back 3 generations to 2001. 189 later devices descend from it.

Decided
Nov 8, 2005
Review
405 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K002652 (2001). 4 ancestors in all. 189 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2007: 6 descendants cleared2006: 3 descendants cleared2020: 16 descendants cleared2009: 2 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2017: 6 descendants cleared2022: 16 descendants cleared2018: 9 descendants cleared2016: 3 descendants cleared2019: 7 descendants cleared2021: 15 descendants cleared2023: 26 descendants cleared2026: 27 descendants cleared2024: 23 descendants cleared2025: 20 descendants clearedK002652 · Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii · Stryker Corp. · 2001 · recalled×2: 2 generations cleared close together, K033801 (2004), K041584 (2004) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 11 descendants5 generations forward: 18 descendants6 generations forward: 32 descendants7 generations forward: 49 descendants8 generations forward: 39 descendants9 generations forward: 15 descendants10 generations forward: 4 descendants K041584 · 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 · recalled0+5+10
  1. Root · 3 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
  2. 2 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
  3. 1 generation backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
  4. This deviceK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
  5. Descendant · cites it directly · 176 of its ownK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
  6. Descendant · 2 generations on · 165 of its ownK102397 Kyphon Xpede Bone CementMedtronic · 2011
  7. Descendant · 3 generations on · 162 of its ownK150460 KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015
  8. Descendant · 4 generations on · 159 of its ownK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  9. Descendant · 5 generations on · 106 of its ownK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016

Showing 5 of 189 descendants. See all descendants

Descendants cleared per year

2006: 32007: 62009: 22010: 12011: 32012: 12013: 12014: 22015: 22016: 32017: 62018: 92019: 72020: 162021: 152022: 162023: 262024: 232025: 202026: 27
2006high 27 (2026) · low 0 (2008)2026

Most influential descendants

Showing 5 of 189 · See all
  • K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · cites it directly176descendants
  • K102397Kyphon Xpede Bone CementMedtronic · 2011 · 2 generations on165descendants
  • K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc. · 2015 · 3 generations on162descendants
  • K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016 · 4 generations on159descendants
  • K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl · 2016 · 5 generations on106descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002652Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp.20011
−2K033801Kyphx HV-R, Model C01AKyphon, Inc.20042
−1K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc.20042
0 (this device)K042691Vertefix Vertebroplasty Procedure SetCook, Inc.2005—
+1K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.20068
+2K102397Kyphon Xpede Bone CementMedtronic2011—
+3K150460KYPHON (R) HV-R (R) Bone CementMedtronic Sofamor Danck USA, Inc.2015—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated…Medos International Sàrl2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200760
200920
201010
201130
201210
201310
201420
201520
201630
201760
201890
201970
2020160
2021150
2022160
2023260
2024230
2025200
2026270
FIG. 1 — Lineage of K042691, 2001–2026Source: 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? (2)

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
*K032945Simplex X
Summary page 1
…ces: Manufacturer Device Name 510(k) # Stryker Corp. SpineplexTM Radiopaque Bone Cement K032945 Kyphon, Inc. KyphX® HV-R Bone Cement Model CO IA K041584 Device Description: The VertefixTM Vertebr…
Stryker Corp.20042
*K041584Kyphx HV-R Bone Cement, Model C01A
Summary page 1
…(k) # Stryker Corp. SpineplexTM Radiopaque Bone Cement K032945 Kyphon, Inc. KyphX® HV-R Bone Cement Model CO IA K041584 Device Description: The VertefixTM Vertebroplasty Procedure Set contains the Vertebroplasty Injector Kit and VertefixTM Radiopaq…
Kyphon, Inc.20042

Also cleared against K032945: 14 other devices →

What descends from it? (189)

See all 189

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

NumberDeviceApplicantDecidedDescendants
K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd.2006176
K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717
K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071

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 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 4 of the 4 ancestors have a recall of any class.
  • Of its descendants, K060300 (Disc-O-Tech Medical Technologies, Ltd., 2006) has gone furthest, with 176 descendants of its own.
  • 14 other devices also cite its predicate K032945.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

VertefixTM Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

Also cleared against K032945

14 other devices cite the same predicate.

  • K220131KYPHON VuE Bone CementTecres S.P.A. · 2022
  • K161114HIGH V+Teknimed Sas · 20171 recall
  • K093477Shield Kyphoplasty SystemSoteira, Inc. · 2011
  • K080108Cortoss Bone Augmentation MaterialOrthovita, Inc. · 20094 recalls
  • K072118Stryker Vertaplex Radiopaque Bone CementStryker Corp. · 2007
  • K070015Cobalt V Radiopaque Vertebroplasty Bone CementBiomet Manufacturing Corp · 2007

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

  • P020018/S070Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchCook, Inc. · 2026
  • P020018/S069Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch…Cook, Inc. · 2026
  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

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/K042691 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042691: Vertefix Vertebroplasty Procedure Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042691

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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