510(k) · Cleared

Cleared

Confidence High Viscosity Spinal Cement, 16G / 20G

K112907510(k) TraditionalCleared Dec 22, 201180-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

Medos International SARL · NDN Cement, Bone, Vertebroplasty

Cleared on Dec 22, 2011 as substantially equivalent to K060300 (Disc-O-Tech Medical Technologies, Ltd., 2006) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 2001.

Decided: Dec 22, 2011
Review: 80 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K002652 (2001). 13 ancestors in all, the oldest K873689 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
4 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
3 generations backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
2 generations backK042691 Vertefix Vertebroplasty Procedure SetCook, Inc. · 2005
1 generation backK060300 Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006 · Recalled
This deviceK112907 Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii	Stryker Corp.	2001	1
−4	K033801	Kyphx HV-R, Model C01A	Kyphon, Inc.	2004	2
−3	K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	2
−2	K042691	Vertefix Vertebroplasty Procedure Set	Cook, Inc.	2005	—
−1	K060300	Confidence High Viscosity Bone Cement	Disc-O-Tech Medical Technologies, Ltd.	2006	8
0 (this device)	K112907	Confidence High Viscosity Spinal Cement, 16G / 20G	Medos International SARL	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1997	1	0
2003	2	0
2004	2	0
2005	1	0
2007	1	0

FIG. 1 — Lineage of K112907, 2001–2011Source: 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
*	K060300	Confidence High Viscosity Bone Cement Summary page 1 …, bone, vertebroplasty Product Code: NDN Equivalent to: Disc-C-Tech Confidence High Viscosity Spinal Cement (K060300) DePuy Spine Vertebroplastic Radiopaque Bone Cement (K07 1927)…	Disc-O-Tech Medical Technologies, Ltd.	2006	8
*	K071927	Modification to Vertebroplastic Radiopaque Bone Cement Summary page 1 …nce High Viscosity Spinal Cement (K060300) DePuy Spine Vertebroplastic Radiopaque Bone Cement (K07 1927) 27 Device Descri…	Depuy Spine, A Johnson & Johnson Company	2007	—

Also cleared against K060300: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
6 of the 13 ancestors have a recall of any class.
6 other devices also cite its predicate K060300.

How does its category compare?

All NDN devices

NDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

CONFIDENCE High Viscosity Spinal Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (baemangioma), or malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K112907: Confidence High Viscosity Spinal Cement, 16G / 20G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112907

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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