510(k) · Cleared

Cleared

Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XX

K070181510(k) TraditionalCleared Apr 18, 200789-day reviewClass II21 CFR 888.3060

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

Sintea Biotech, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Apr 18, 2007 as substantially equivalent to K003155 (Osteotech, Inc., 2001) after an 89-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Apr 18, 2007
Review: 89 days
Class: Class II
Product code: MQP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003155 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
This deviceK070181 Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XXSintea Biotech, Inc. · 2007
Descendant · cites it directly · 0 of its ownK101886 DSC/Alf Spinal SystemSintea Plastek, LLC · 2011

Most influential descendants

Showing 1 of 1 · See all

K101886DSC/Alf Spinal SystemSintea Plastek, LLC · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003155	Vertebral Body Replacement	Osteotech, Inc.	2001	—
0 (this device)	K070181	Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XX	Sintea Biotech, Inc.	2007	—
+1	K101886	DSC/Alf Spinal System	Sintea Plastek, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K070181, 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 MQP? 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 MQP device

#1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
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What was it cleared against? (1)

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
*	K003155	Vertebral Body Replacement Summary page 2 …ented in the body of the 5 10O(k). VI. Substantial Equivalence Sintea Biotech, Inc. believes that the DSC/ALF Spinal System is substantially equivalent to the VBR TM (K003 155) Made by Ulrich GmbH & Co, with respect to functional design, indications for use, principles of operation, and performance. The…	Osteotech, Inc.	2001	—

Also cleared against K003155: 6 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
K101886	DSC/Alf Spinal System	Sintea Plastek, LLC	2011	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?

Its one ancestor has no recall.
Of its descendants, K101886 (Sintea Plastek, LLC, 2011) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K003155.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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	30	107	2	61
2008	17	47	0	76
2009	11	115	14	111
2010	6	174	2	166
2011	8	237	1	121
2012	7	82	2	141
2013	3	90	0	207
2014	5	125	0	216
2015	8	126	0	258
2016	0	—	0	129
2017	9	97	0	141
2018	6	152	0	130
2019	8	93	0	117
2020	3	103	15	157
2021	0	—	0	208
2022	1	—	1	137
2023	1	—	0	71
2024	4	187	0	98
2025	0	—	0	168
2026	3	102	0	—

What is it indicated for?

The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF system is to be used with the anterior lateral plate that is included in the system, and may also be used with the Sintea Biotech PLS Spinal System. Additionally, the DSC/ALF system is intended to be used with bone graft.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070181 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070181: Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070181

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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