510(k) · Cleared

Recalled · Class II · 2013

Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System

K102090510(k) SpecialCleared Sep 30, 201066-day reviewClass II21 CFR 888.3080Recalls 1

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

Spine Smith Partners L.P. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Sep 30, 2010 as substantially equivalent to K090376 (Spine Smith Partners L.P., 2009) after a 66-day review. Its family tree reaches back 2 generations to 1996. 1 of the 479 devices in its family, counting itself, has a Class I recall. 473 later devices descend from it. It has been recalled once.

Decided: Sep 30, 2010
Review: 66 days
Class: Class II
Product code: OVD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to P950002 (1996). 5 ancestors in all. 473 later devices descend from it, 5 citing it directly. 1 of the 479 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
1 generation backK090376 Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 2009
This deviceK102090 Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant…Spine Smith Partners L.P. · 2010
Descendant · cites it directly · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
Descendant · 2 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
Descendant · 3 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
Descendant · 2 generations on · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
Descendant · 3 generations on · 189 of its ownK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled

Showing 5 of 473 descendants. See all descendants

Descendants cleared per year

2012high 78 (2024) · low 0 (2013)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 473 · See all

K141942Midline II TICentinel Spine, Inc. · 2014 · cites it directly459descendants
K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 2 generations on368descendants
K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 3 generations on236descendants
K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015 · 2 generations on220descendants
K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · 3 generations on189descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P950002	Bak Interbody Fusion System	Zimmer Spine, Inc.	1996	—
−1	K090376	Spinesmith Cynch Spinal System	Spine Smith Partners L.P.	2009	—
0 (this device)	K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System	Spine Smith Partners L.P.	2010	—
+1	K141942	Midline II TI	Centinel Spine, Inc.	2014	—
+2	K150643	Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti	Centinel Spine, Inc.	2015	—
+3	K152475	FORZA PTC Spacer System	Orthofix, Inc.	2016	—
+2	K151214	ALIF Interfixated System	Nu Vasive, Incorporated	2015	—
+3	K153495	Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage…	Ldr Spine USA	2016	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2014	2	0
2015	4	0
2016	13	0
2017	13	0
2018	21	0
2019	32	0
2020	40	0
2021	42	1
2022	55	0
2023	58	0
2024	78	0
2025	63	0
2026	50	0

FIG. 1 — Lineage of K102090, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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 OVD device

#1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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? (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
*	K090376	Spinesmith Cynch Spinal System Summary page 1 …plant System ’ IDENTIFICATION OF PREDICATE DEVICES: The SpineSmith Visualif System was determined to be substantially equivalent to the previously cleared Cynch System (K090376, SpineSmith; Cleared 4/1/2009). DEVICE DESCRIPTION: The Visualif System is part of the Cynch Spinal System and is available in…	Spine Smith Partners L.P.	2009	—

Also cleared against K090376: 2 other devices →

What descends from it? (473)

See all 473

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

Number	Device	Applicant	Decided	Descendants
K141942	Midline II TI	Centinel Spine, Inc.	2014	459
K133827	A-Link Z	Osteo Vasive, LLC	2014	26
K112561	Nuvasive Coroent NO-Profile System	Nuvasive, Inc.	2012	12
K122168	Visualif Challenging Access Plate	Spine Smith Partners L.P.	2012	1
K180519	HARRIER-SA™ Lumbar Interbody System	Choicespine, LP	2018	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 31, 2013	Class II	Z-2258-2013	Process control	The product has the potential to be laser marked as a Medium when it actually is a Small.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.5 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K141942 (Centinel Spine, Inc., 2014) has gone furthest, with 459 descendants of its own.
2 other devices also cite its predicate K090376.

How does its category compare?

All OVD devices

OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OVD

10in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OVD

50in 2025

2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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	2	—	0	0
2008	8	84	0	0
2009	3	152	0	2
2010	8	117	0	2
2011	9	167	0	6
2012	10	78	0	16
2013	11	137	4	17
2014	14	139	0	35
2015	12	166	0	43
2016	13	127	1	55
2017	12	127	0	72
2018	14	126	0	112
2019	12	91	0	171
2020	14	91	0	203
2021	7	108	1	221
2022	14	133	1	74
2023	12	92	0	67
2024	12	110	0	92
2025	10	100	1	50
2026	8	93	1	—

What is it indicated for?

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…

Read the full statement (162 words)

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.

The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

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/K102090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102090

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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