510(k) · Cleared

Cleared

Mendec Spine HV, Mendec Spine HV System

K122175510(k) TraditionalCleared Mar 28, 2013248-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 Mar 28, 2013 as substantially equivalent to K033801 (Kyphon, Inc., 2004) and 2 other predicates after a 248-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.

Decided: Mar 28, 2013
Review: 248 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K002652 (2001). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
3 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
2 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
1 generation backK042415 Mendec SpineTecres S.P.A. · 2005
This deviceK122175 Mendec Spine HV, Mendec Spine HV SystemTecres S.P.A. · 2013
Descendant · cites it directly · 0 of its ownK230774 PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023

Most influential descendants

Showing 1 of 1 · See all

K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii	Stryker Corp.	2001	1
−3	K033801	Kyphx HV-R, Model C01A	Kyphon, Inc.	2004	2
−2	K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	2
−1	K042415	Mendec Spine	Tecres S.P.A.	2005	—
0 (this device)	K122175	Mendec Spine HV, Mendec Spine HV System	Tecres S.P.A.	2013	—
+1	K230774	PERLA® TL System; TEKTONA® HV US Bone Cement	Spineart	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K122175, 2001–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K033801	Kyphx HV-R, Model C01A Summary page 2 …1-02. 510k Summary * Kyphx HV-R Bone Cement (Kyphon Inc.), cleared in the 510(k) submission #K033801 and WK093828; and, * Mendec Spine (Tecres), cleared in the 510(k) submission…	Kyphon, Inc.	2004	2
*	K093828	Kyph X HV-R Bone Cement Summary page 2 …Summary * Kyphx HV-R Bone Cement (Kyphon Inc.), cleared in the 510(k) submission #K033801 and WK093828; and, * Mendec Spine (Tecres), cleared in the 510(k) submission…	Medtronic, Inc.	2010	—
*	K042415	Mendec Spine	Tecres S.P.A.	2005	—

Also cleared against K033801: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K230774	PERLA® TL System; TEKTONA® HV US Bone Cement	Spineart	2023	0

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 12 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
4 of the 6 ancestors have a recall of any class.
Of its descendants, K230774 (Spineart, 2023) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.

FDA decisions per year · NDN

2in 2025

2007high 11 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDN

90in 2024

2007high 215 (2010) · low 76 (2015)2026

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

Recalls per year · NDN

4in 2013

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	128	0	21
2008	1	—	0	39
2009	6	211	1	70
2010	5	215	0	396
2011	11	164	0	98
2012	7	90	0	89
2013	7	118	4	242
2014	7	106	0	231
2015	6	76	0	204
2016	4	154	0	182
2017	5	125	0	191
2018	3	111	0	144
2019	2	—	0	227
2020	4	157	0	212
2021	2	—	0	344
2022	2	—	0	270
2023	2	—	0	311
2024	3	90	0	454
2025	2	—	0	626
2026	1	—	0	—

What is it indicated for?

Mendec Spine HV / Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty 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.

https://510kreport.com/device/K122175 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122175: Mendec Spine HV, Mendec Spine HV System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122175

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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