510(k) · Cleared

Cleared

Synthes Spine Posterior Cervical/Thoracic Hook/Rod System

K980358510(k) TraditionalCleared Apr 16, 199877-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

Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Apr 16, 1998 as substantially equivalent to K850039 (Levtech, Inc., 1985) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1985.

Decided: Apr 16, 1998
Review: 77 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K850039 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK850039 Halifax Spinal ClampLevtech, Inc. · 1985
1 generation backK962314 Halifax Plus Interlaminar Clamp SystemOsteonics Corp. · 1996
This deviceK980358 Synthes Spine Posterior Cervical/Thoracic Hook/Rod SystemSynthes (Usa) · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K850039	Halifax Spinal Clamp	Levtech, Inc.	1985	—
−1	K962314	Halifax Plus Interlaminar Clamp System	Osteonics Corp.	1996	—
0 (this device)	K980358	Synthes Spine Posterior Cervical/Thoracic Hook/Rod System	Synthes (Usa)	1998	—

FIG. 1 — Lineage of K980358, 1985–1998Source: 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? (2)

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
*	K850039	Halifax Spinal Clamp Our OCR of the scanned summary read K850030, FDA’s number for Concentrical Continuous Passive Motion Machine (Arc Motion, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AME Halifax Interlaminar Clamp System”.	Levtech, Inc.	1985	—
*	K962314	Halifax Plus Interlaminar Clamp System Our OCR of the scanned summary read K062314, FDA’s number for Horus Laser Keratome (Carl Zeiss Meditec, AG), decided Dec 22, 2006, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AME Halifax Interlaminar Clamp System”.	Osteonics Corp.	1996	—

Also cleared against K850039: 1 other device →

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 13 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K850039.

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 Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) 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/K980358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980358: Synthes Spine Posterior Cervical/Thoracic Hook/Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980358

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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