510(k) · Cleared

Cleared

Basis Spinal System

K050484510(k) TraditionalCleared May 4, 200568-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 May 4, 2005 as substantially equivalent to K042025 (Medtronic Sofamor Danek, Inc., 2004) and 2 other predicates after a 68-day review. Its family tree reaches back 3 generations to 2004.

Decided: May 4, 2005
Review: 68 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K040583 (2004). 10 ancestors in all, the oldest K981676 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
2 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
1 generation backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
This deviceK050484 Basis Spinal SystemMedtronic Sofamor Danek, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K040583	Modification to: CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
−2	K041118	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek	2004	—
−1	K042025	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2004	4
0 (this device)	K050484	Basis Spinal System	Medtronic Sofamor Danek, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	2	0
2002	1	0
2003	2	0
2004	1	0

FIG. 1 — Lineage of K050484, 2004–2005Source: 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 KWP? 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

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What was it cleared against? (3)

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
*	K042025	Modification to CD Horizon Spinal System Summary page 2 …tion was provided which demonstrated the BASISTM Spinal System to be substantially equivalent to the following systems: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676). 1.-2-o -'b2.…	Medtronic Sofamor Danek, Inc.	2004	4
*	K020709	Modification to CD Horizon Spinal System Summary page 2 …provided which demonstrated the BASISTM Spinal System to be substantially equivalent to the following systems: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676). 1.-2-o -'b2. === Pag…	Medtronic Sofamor Danek	2002	—
*	K981676	CD Horizon Spinal System Summary page 2 …ch demonstrated the BASISTM Spinal System to be substantially equivalent to the following systems: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676). 1.-2-o -'b2.…	Sofamor Danek USA,Inc.	1999	—

Also cleared against K042025: 36 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 3 months on median.
2 of the 10 ancestors have a recall of any class.
36 other devices also cite its predicate K042025.

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	—

What is it indicated for?

The BASISTM Screws and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar, BASISTM components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050484 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050484: Basis 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/K050484

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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