510(k) · Cleared

Cleared

Spinesmith Cynch Spinal System

K090376510(k) TraditionalCleared Apr 1, 200943-day reviewClass II21 CFR 888.3080

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. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 1, 2009 as substantially equivalent to P970015 (Sofamor Danek, 1999) and 3 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1996. 1 of the 481 devices in its family, counting itself, has a Class I recall. 476 later devices descend from it.

Decided: Apr 1, 2009
Review: 43 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to P950002 (1996). 4 ancestors in all. 476 later devices descend from it, 3 citing it directly. 1 of the 481 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
This deviceK090376 Spinesmith Cynch Spinal SystemSpine Smith Partners L.P. · 2009
Descendant · cites it directly · 473 of its ownK102090 Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant…Spine Smith Partners L.P. · 2010 · Recalled
Descendant · 2 generations on · 459 of its ownK141942 Midline II TICentinel Spine, Inc. · 2014
Descendant · 3 generations on · 368 of its ownK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
Descendant · 4 generations on · 236 of its ownK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
Descendant · 3 generations on · 220 of its ownK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015

Showing 5 of 476 descendants. See all descendants

Descendants cleared per year

2010high 78 (2024) · low 0 (2013)2026

Class I recalls in this family

K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 476 · See all

K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P. · 2010 · cites it directly473descendants
K141942Midline II TICentinel Spine, Inc. · 2014 · 2 generations on459descendants
K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015 · 3 generations on368descendants
K152475FORZA PTC Spacer SystemOrthofix, Inc. · 2016 · 4 generations on236descendants
K151214ALIF Interfixated SystemNu Vasive, Incorporated · 2015 · 3 generations on220descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P950002	Bak Interbody Fusion System	Zimmer Spine, Inc.	1996	—
0 (this device)	K090376	Spinesmith Cynch Spinal System	Spine Smith Partners L.P.	2009	—
+1	K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System	Spine Smith Partners L.P.	2010	1
+2	K141942	Midline II TI	Centinel Spine, Inc.	2014	—
+3	K150643	Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti	Centinel Spine, Inc.	2015	—
+4	K152475	FORZA PTC Spacer System	Orthofix, Inc.	2016	—
+3	K151214	ALIF Interfixated System	Nu Vasive, Incorporated	2015	—

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
2010	2	0
2011	1	0
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 K090376, 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 MAX device

#1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (4)

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
*	P970015	Inter Fix Threaded Fusion Device Summary page 1 …cages: - LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03)…	Sofamor Danek	1999	1
*	P950002	Bak Interbody Fusion System Summary page 1 …(P970015, Medtronic Sofamor Danek, Approved 9/10/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03)…	Zimmer Spine, Inc.	1996	—
*	P950019	Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation Summary page 1 …(P950002, Zimmer Spine, Approved 7/8/03) - RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03) -…	Stryker Spine	1996	1
*	P960025	Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws Summary page 1 …ed Fusion Cage (P950019, Stryker, Approved 9/4/03) - Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) SpineSmith Partners, LP 8140 N. Mopac, Bldg I, Suite 1…	Depuy Spine, Inc.	1999	—

Also cleared against P970015: 18 other devices →

What descends from it? (476)

See all 476

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

Number	Device	Applicant	Decided	Descendants
K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System	Spine Smith Partners L.P.	2010	473
K110177	Helena System	Royal Oak Medical Devices	2011	0
K101085	Spinesmith Cynch Spinal System	Spine Smith Partners L.P.	2010	0

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

No FDA recall names this device.

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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K102090 (Spine Smith Partners L.P., 2010) has gone furthest, with 473 descendants of its own.
18 other devices also cite its predicate P970015.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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	7	86	0	12
2008	35	88	2	19
2009	31	102	9	90
2010	29	137	0	154
2011	49	98	3	201
2012	48	69	11 (1)	327
2013	58	102	0	380
2014	58	115	3	366
2015	53	113	1	524
2016	64	124	6	647
2017	76	116	1	596
2018	64	114	4	616
2019	60	131	1	699
2020	56	106	0	640
2021	53	109	0	622
2022	41	95	1	618
2023	30	87	0	576
2024	38	91	1	729
2025	29	85	5	811
2026	18	95	0	—

What is it indicated for?

The Cynch System is indicated 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 autografi to facilitate fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090376 · printed Nov 3, 2026

Cite this page

510(k) Report. “K090376: Spinesmith Cynch Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090376

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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