510(k) · Cleared

Cleared

Spine-Fix Biomimetic Bone Cement

K043593510(k) TraditionalCleared Mar 17, 2006443-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

Teknimed, S.A. · NDN Cement, Bone, Vertebroplasty

Cleared on Mar 17, 2006 as substantially equivalent to K041584 (Kyphon, Inc., 2004) and 1 other predicate after a 443-day review. Its family tree reaches back 3 generations to 2001. 22 later devices descend from it.

Decided: Mar 17, 2006
Review: 443 days
Class: Class II
Product code: NDN
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K002652 (2001). 5 ancestors in all, the oldest K003294 (2000). 22 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK002652 Surgical Simplex P Radiopaque Bone Cement and Acm and MixevaciiStryker Corp. · 2001 · Recalled
2 generations backK033801 Kyphx HV-R, Model C01AKyphon, Inc. · 2004 · Recalled
1 generation backK041584 Kyphx HV-R Bone Cement, Model C01AKyphon, Inc. · 2004 · Recalled
This deviceK043593 Spine-Fix Biomimetic Bone CementTeknimed, S.A. · 2006
Descendant · cites it directly · 20 of its ownK080873 Opacity + Bone CementTeknimed, S.A. · 2008
Descendant · cites it directly · 18 of its ownK103433 F20Teknimed, S.A. · 2011
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
Descendant · 4 generations on · 4 of its ownK242364 IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008high 7 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 22 · See all

K080873Opacity + Bone CementTeknimed, S.A. · 2008 · cites it directly20descendants
K103433F20Teknimed, S.A. · 2011 · cites it directly18descendants
K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on14descendants
K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants
K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc. · 2024 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002652	Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii	Stryker Corp.	2001	1
−2	K033801	Kyphx HV-R, Model C01A	Kyphon, Inc.	2004	2
−1	K041584	Kyphx HV-R Bone Cement, Model C01A	Kyphon, Inc.	2004	2
0 (this device)	K043593	Spine-Fix Biomimetic Bone Cement	Teknimed, S.A.	2006	—
+1	K080873	Opacity + Bone Cement	Teknimed, S.A.	2008	—
+1	K103433	F20	Teknimed, S.A.	2011	—
+2	K221926	Invictus® Bone Cement, Invictus Spinal Fixation System	Alphatec Spine, Inc.	2022	—
+3	K232275	Invictus® Spinal Fixation System	Alphatec Spine, Inc.	2023	—
+4	K242364	IdentiTi™ II Interbody System	Alphatec Spine, Inc.	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2011	2	0
2022	1	0
2023	3	0
2024	4	0
2025	3	0
2026	7	0

FIG. 1 — Lineage of K043593, 2001–2026Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K041584	Kyphx HV-R Bone Cement, Model C01A Summary page 1 …Class II per 21 CFR section 888.3027 Product Code NDN Equivalent Device KYPHX HV-R Bone Cement, MODEL COlA (Kyphon, Inc. - K041584) Spineplex® (Stryker Corp. - K0032945) Device Description Spine-Fix is a self hardening and ready to…	Kyphon, Inc.	2004	2
*	K003294	Biomet Lateral Troch Plate Summary page 1 …uct Code NDN Equivalent Device KYPHX HV-R Bone Cement, MODEL COlA (Kyphon, Inc. - K041584) Spineplex® (Stryker Corp. - K0032945) Device Description Spine-Fix is a self hardening and ready to use bone cement with a high amount of radiopaque agent for percu…	Biomet, Inc.	2000	2

Also cleared against K041584: 9 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K080873	Opacity + Bone Cement	Teknimed, S.A.	2008	20
K103433	F20	Teknimed, S.A.	2011	18
K103816	Cohesion Bone Cement	Teknimed Sas	2011	0
K080108	Cortoss Bone Augmentation Material	Orthovita, Inc.	2009	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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
5 of the 5 ancestors have a recall of any class.
Of its descendants, K080873 (Teknimed, S.A., 2008) has gone furthest, with 20 descendants of its own.
9 other devices also cite its predicate K041584.

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

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?

Spine Fix cement is used 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 (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043593 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043593: Spine-Fix Biomimetic Bone Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043593

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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