510(k) · Cleared

Cleared

Dyna-Lok Classic Spinal System

K001532510(k) SpecialCleared Jun 16, 200030-day reviewClass II21 CFR 888.3050

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

Medtronic Sofamor Danek, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 16, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 998 devices in its family, counting itself, has a Class I recall. 997 later devices descend from it.

Decided: Jun 16, 2000
Review: 30 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

997 later devices descend from it, 3 citing it directly. 1 of the 998 devices in this family, counting this one, has a Class I recall.

This deviceK001532 Dyna-Lok Classic Spinal SystemMedtronic Sofamor Danek, Inc. · 2000
Descendant · cites it directly · 987 of its ownK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
Descendant · 2 generations on · 880 of its ownK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
Descendant · cites it directly · 880 of its ownK041862 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
Descendant · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
Descendant · 2 generations on · 822 of its ownK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · Recalled

Showing 5 of 997 descendants. See all descendants

Descendants cleared per year

2002high 91 (2023) · low 1 (2002)2026

Class I recalls in this family

K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 997 · See all

K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly987descendants
K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on880descendants
K041862CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly880descendants
K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on870descendants
K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on822descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001532	Dyna-Lok Classic Spinal System	Medtronic Sofamor Danek, Inc.	2000	—
+1	K042025	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2004	4
+2	K043151	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2005	—
+1	K041862	CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
+2	K050809	CD Horizon Spinal System	Medtronic Sofamor Danek USA, Inc.	2005	—
+2	K060615	CD Horizon Spinal System	Medtronic Sofamor Danek	2006	34

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2005	11	0
2006	7	0
2007	5	0
2008	8	0
2009	13	0
2010	9	0
2011	15	0
2012	32	0
2013	50	0
2014	50	0
2015	55	0
2016	54	0
2017	58	0
2018	62	0
2019	49	0
2020	68	0
2021	61	1
2022	73	0
2023	91	0
2024	77	0
2025	74	0
2026	71	0

FIG. 1 — Lineage of K001532, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (997)

See all 997

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

Number	Device	Applicant	Decided	Descendants
K042025	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2004	987
K041862	CD Horizon Spinal System	Medtronic Sofamor Danek	2004	880
K014302	Universal Multiaxis (Unimax) Pedicle Screw System	Pisharodi Surgicals, Inc.	2002	1

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

What does this lineage say?

Of its descendants, K042025 (Medtronic Sofamor Danek, Inc., 2004) has gone furthest, with 987 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

https://510kreport.com/device/K001532 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001532: Dyna-Lok Classic Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001532

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026