510(k) · Cleared

Cleared

Halm Zielke Instrumentation System

K024125510(k) TraditionalCleared Sep 22, 2003280-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

Micomed Ortho GmbH · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Sep 22, 2003 as substantially equivalent to K982006 (Micomed GmbH, 1999) and 3 other predicates after a 280-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.

Decided: Sep 22, 2003
Review: 280 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K782061 (1979). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK782061 Spinal Surgery InstrumentationStuart Drug & Surgical Supply, Inc. · 1979
This deviceK024125 Halm Zielke Instrumentation SystemMicomed Ortho GmbH · 2003
Descendant · cites it directly · 0 of its ownK102406 Pass Anterior Spinal SystemMedicrea Technologies · 2011

Most influential descendants

Showing 1 of 1 · See all

K102406Pass Anterior Spinal SystemMedicrea Technologies · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K782061	Spinal Surgery Instrumentation	Stuart Drug & Surgical Supply, Inc.	1979	—
0 (this device)	K024125	Halm Zielke Instrumentation System	Micomed Ortho GmbH	2003	—
+1	K102406	Pass Anterior Spinal System	Medicrea Technologies	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K024125, 1979–2011Source: 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? (4)

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
*	K982006	Micomed - Halm Zielke Instrumentation Summary page 1 Prcmurker NorrJicurionfor New Coniponenfs for Micomed Halm Zielke Instrumentation System Refirence 5 I O(k) K982006 Deceniher 12, 2002 SEP 2 2 2003 Attachment 12…	Micomed GmbH	1999	—
*	K782061	Spinal Surgery Instrumentation Summary page 1 …cbonfiglio(@meister.net Predicate Micomed Halm Zielke Instrumentation System, 5 1O(k) #K982006 Devices: Zielke V.D.S. System, 5 1O(k) #K78206 1 DePuy AcroMed MOSS Miami Spinal System, 510(k) #K983583 Kaneda Anterior Scoliosis Syste…	Stuart Drug & Surgical Supply, Inc.	1979	—
*	K983583	Depuy Acromed Moss and Moss Miami Spinal Systems Summary page 1 …nstrumentation System, 5 1O(k) #K982006 Devices: Zielke V.D.S. System, 5 1O(k) #K78206 1 DePuy AcroMed MOSS Miami Spinal System, 510(k) #K983583 Kaneda Anterior Scoliosis System, 5 1 O(k) #K974757 Description: The principal components of the…	Depuy, Inc.	1998	—
*	K974757	Kaneda Anterior Scoliosis System Kass Summary page 1 …. System, 5 1O(k) #K78206 1 DePuy AcroMed MOSS Miami Spinal System, 510(k) #K983583 Kaneda Anterior Scoliosis System, 5 1 O(k) #K974757 Description: The principal components of the Micomed Halm Zielke Instrumentation System, whi…	Acromed Corp.	1998	—

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
K102406	Pass Anterior Spinal System	Medicrea Technologies	2011	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?

None of the 4 ancestors has a recall.
Of its descendants, K102406 (Medicrea Technologies, 2011) 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 Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for

spinal deformities in the thoracic and lumbar spine such as scoliosis, kyphosis, lordosis and

thoracolumbar spinal instability caused by fracture.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024125: Halm Zielke Instrumentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024125

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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