510(k) · Cleared

Cleared

Vertelink Kobra Spinal Fixation System

K032102510(k) TraditionalCleared Dec 12, 2003157-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

Vertelink Corporation · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 12, 2003 as substantially equivalent to K030932 (Medtronic Sofamor Danek, Inc., 2003) after a 157-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Dec 12, 2003
Review: 157 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K030932 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK030932 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2003
This deviceK032102 Vertelink Kobra Spinal Fixation SystemVertelink Corporation · 2003
Descendant · cites it directly · 0 of its ownK042859 Kobra GPS Fixation SystemMedtronic Vertelink, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K042859Kobra GPS Fixation SystemMedtronic Vertelink, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030932	CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2003	—
0 (this device)	K032102	Vertelink Kobra Spinal Fixation System	Vertelink Corporation	2003	—
+1	K042859	Kobra GPS Fixation System	Medtronic Vertelink, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K032102, 2003–2004Source: 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 KWQ? 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (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
*	K030932	CD Horizon Spinal System Summary page 1 …o which we are claiming equivalence [807.92(a)(3)]: CD HORIZON® Spinal System, manufactured by Medtronic Sofamor Danek, Inc. USA. The clearance number is K030932. Description of the device: The Vertelink KOBRA TM Spinal Fixation System is designed to provide immobilizat…	Medtronic Sofamor Danek, Inc.	2003	—

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
K042859	Kobra GPS Fixation System	Medtronic Vertelink, Inc.	2004	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, K042859 (Medtronic Vertelink, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

Read the full statement (114 words)

1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis, 7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L3 and below), d. Who are having the device removed after the development of solid fusion mass.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032102 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032102: Vertelink Kobra Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032102

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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