510(k) · Cleared

Recalled · Class II · 2022

HIGH V+

K161114510(k) TraditionalCleared Apr 12, 2017357-day reviewClass II21 CFR 888.3027Recalls 1

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

Teknimed Sas · NDN Cement, Bone, Vertebroplasty

Cleared on Apr 12, 2017 as substantially equivalent to K090435 (Teknimed, S.A., 2009) and 1 other predicate after a 357-day review. Its family tree reaches back 1 generation to 2004. 42 later devices descend from it. It has been recalled once.

Decided: Apr 12, 2017
Review: 357 days
Class: Class II
Product code: NDN
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K032945 (2004). 2 ancestors in all. 42 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK032945 Simplex XStryker Corp. · 2004 · Recalled
This deviceK161114 HIGH V+Teknimed Sas · 2017
Descendant · cites it directly · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
Descendant · cites it directly · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
Descendant · 2 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
Descendant · 2 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Descendant · 3 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2018high 10 (2024) · low 1 (2018)2026

Most influential descendants

Showing 5 of 42 · See all

K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · cites it directly41descendants
K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · cites it directly28descendants
K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 2 generations on27descendants
K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on14descendants
K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K032945	Simplex X	Stryker Corp.	2004	2
0 (this device)	K161114	HIGH V+	Teknimed Sas	2017	—
+1	K180498	NuVasive Reline Fenestrated Screws, High V+ Bone Cement	Nu Vasive, Incorporated	2018	—
+1	K190526	High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws	CarboFix Orthopedics, Ltd.	2019	—
+2	K200596	G21 Cement, VADER® Pedicle System	Icotec AG	2020	1
+2	K221926	Invictus® Bone Cement, Invictus Spinal Fixation System	Alphatec Spine, Inc.	2022	—
+3	K232275	Invictus® Spinal Fixation System	Alphatec Spine, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	3	0
2020	3	0
2021	2	0
2022	3	0
2023	8	0
2024	10	0
2025	5	0
2026	7	0

FIG. 1 — Lineage of K161114, 2004–2026Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K090435	Vertecem Summary page 4 …Product Code: NDN CFR section: 21 CFR section 888.3027 Device panel: Orthopedic PrimaryLegally Vertecem, K090435 Marketed Predicate Device: Secondary Legally Spineplex K032945 Market…	Teknimed, S.A.	2009	—
*	K032945	Simplex X Summary page 4 …panel: Orthopedic PrimaryLegally Vertecem, K090435 Marketed Predicate Device: Secondary Legally Spineplex K032945 Marketed Predicate Device: Submitter: Teknimed, SAS…	Stryker Corp.	2004	2

Also cleared against K090435: 3 other devices →

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K180498	NuVasive Reline Fenestrated Screws, High V+ Bone Cement	Nu Vasive, Incorporated	2018	41
K190526	High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws	CarboFix Orthopedics, Ltd.	2019	28

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 15, 2022	Class II	Z-1099-2023	Employee error	Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K180498 (Nu Vasive, Incorporated, 2018) has gone furthest, with 41 descendants of its own.
3 other devices also cite its predicate K090435.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?

The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.

Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K161114 · printed Nov 4, 2026

Cite this page

510(k) Report. “K161114: HIGH V+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161114

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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