510(k) · Cleared

Cleared

Modification of the Zplate-Atl Anterior Fixation System

K990603510(k) SpecialCleared Mar 10, 199915-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

Danek Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 10, 1999 after a 15-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided: Mar 10, 1999
Review: 15 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK990603 Modification of the Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999
Descendant · cites it directly · 0 of its ownK051039 Basis Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990603	Modification of the Zplate-Atl Anterior Fixation System	Danek Medical, Inc.	1999	—
+1	K051039	Basis Spinal System	Medtronic Sofamor Danek USA, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K990603, 1999–2005Source: 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 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
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What was it cleared against?

The FDA summary names no predicate by number.

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
K051039	Basis Spinal System	Medtronic Sofamor Danek USA, Inc.	2005	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?

Of its descendants, K051039 (Medtronic Sofamor Danek USA, Inc., 2005) 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?

The ZPLATE-ATL™ Anterior Fixation System is intended for screw/bolt fixation/ attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible. When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1.…

Read the full statement (181 words)

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

2. Pseudoarthrosis.

3. Spondylolysis.

4. Spondylolisthesis.

5. Fracture.

6. Neoplastic disease.

7. Unsuccessful previous fusion surgery.

8. Lordotic deformities of the spine.

9. Idiopathic thoracolumbar or lumbar scoliosis

10. Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.

11. Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Warning: This device is not approved for screw attachment to the posterior elements (pedicle) of the cervical, thoracic, or lumbar spine.

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/K990603 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990603: Modification of the Zplate-Atl Anterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990603

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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