# K024125: Halm Zielke Instrumentation System

- Pathway: 510(k) (Traditional)
- Applicant: Micomed Ortho GmbH
- Decided: Sep 22, 2003 after 280 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K782061 (1979). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982006: Micomed - Halm Zielke Instrumentation, Micomed GmbH (1999) Summary page 1.
- K782061: Spinal Surgery Instrumentation, Stuart Drug & Surgical Supply, Inc. (1979) Summary page 1.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 1.

## Most influential descendants
- K102406: Pass Anterior Spinal System (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K024125
Methodology: https://510kreport.com/methodology