510(k) Report

510(k) · Cleared

Cleared

Mendec Spine

K042415510(k) TraditionalCleared Jun 9, 2005275-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

Tecres S.P.A. · NDN Cement, Bone, Vertebroplasty

Cleared on Jun 9, 2005 as substantially equivalent to K033801 (Kyphon, Inc., 2004) and 2 other predicates after a 275-day review. Its family tree reaches back 3 generations to 2001. 28 later devices descend from it.

Decided
Jun 9, 2005
Review
275 days
Class
Class II
Product code
NDN
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K002652 (2001). 4 ancestors in all. 28 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2006: 2 descendants cleared2007: 6 descendants cleared2013: 2 descendants cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared2025: 2 descendants cleared2012: 1 descendant cleared2009: 1 descendant cleared2014: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant 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: 5 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant 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
  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 deviceK042415 Mendec SpineTecres S.P.A. · 2005
  5. Descendant · cites it directly · 18 of its ownK062452 Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006
  6. Descendant · 2 generations on · 17 of its ownK063248 Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007
  7. Descendant · 3 generations on · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
  8. Descendant · 4 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
  9. Descendant · 5 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006: 22007: 62009: 12010: 12011: 12012: 12013: 22014: 22018: 12020: 22021: 12022: 12023: 22024: 22025: 22026: 1
2006high 6 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 28 · See all
  • K062452Kit Mendec Spine and Delivery SystemTecres S.P.A. · 2006 · cites it directly18descendants
  • K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek · 2007 · 2 generations on17descendants
  • K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · 3 generations on10descendants
  • K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 4 generations on9descendants
  • K181262SpineJack Expansion KitVexim SA · 2018 · 5 generations on4descendants
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)K042415Mendec SpineTecres S.P.A.2005—
+1K062452Kit Mendec Spine and Delivery SystemTecres S.P.A.2006—
+2K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek2007—
+3K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.2007—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.2014—
+5K181262SpineJack Expansion KitVexim SA2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200760
200910
201010
201110
201210
201320
201420
201810
202020
202110
202210
202320
202420
202520
202610
FIG. 1 — Lineage of K042415, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K033801Kyphx HV-R, Model C01A
Summary page 1
…ne: +39 045 9217311 Fax: +39 045 9217330 Contact person: Massimo Grazioli. Gencral Mana'er Predicate device: K03380 1: Kypphx H\-RZBone Cement (Kyphon Inc.). K041584: Kyphx HV-R Bone Cement (Kyphon Inc…
Kyphon, Inc.20042
*K041584Kyphx HV-R Bone Cement, Model C01A
Summary page 1
…: Massimo Grazioli. Gencral Mana'er Predicate device: K03380 1: Kypphx H\-RZBone Cement (Kyphon Inc.). K041584: Kyphx HV-R Bone Cement (Kyphon Inc.). K032945: Stryker Spineplex Radiopaque Bone…
Kyphon, Inc.20042
*K032945Simplex X
Summary page 1
…380 1: Kypphx H\-RZBone Cement (Kyphon Inc.). K041584: Kyphx HV-R Bone Cement (Kyphon Inc.). K032945: Stryker Spineplex Radiopaque Bone Cement (Stryker) Indications for use: Mendec Spine is indicated for the tre…
Stryker Corp.20042

Also cleared against K033801: 5 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K062452Kit Mendec Spine and Delivery SystemTecres S.P.A.200618
K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed, Ltd.20242
K061531Space Cpsxl Bone CementDfine, Inc.20062
K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A.20131
K063438VspspnTecres S.P.A.20070

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 11 months on median.
  • 4 of the 4 ancestors have a recall of any class.
  • Of its descendants, K062452 (Tecres S.P.A., 2006) has gone furthest, with 18 descendants of its own.
  • 5 other devices also cite its predicate K033801.

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?

Mendec Spine is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporesis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

Also cleared against K033801

5 other devices cite the same predicate.

  • K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A. · 2013
  • K102397Kyphon Xpede Bone CementMedtronic · 2011
  • K093828Kyph X HV-R Bone CementMedtronic, Inc. · 2010
  • K042168CONCORD Radiopaque Bone CementGlobus Medical, Inc. · 2005
  • K041584Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 20042 recalls

More from Tecres S.P.A.

14 FDA decisions under this applicant name. See the company

  • K252326InterSpace GV Hip SpacerTecres S.P.A. · 2025
  • K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A. · 2023
  • K220131KYPHON VuE Bone CementTecres S.P.A. · 2022
  • K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATSTecres S.P.A. · 2019
  • K122175Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A. · 2013

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/K042415 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042415: Mendec Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042415

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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