# K982006: Micomed - Halm Zielke Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Micomed GmbH
- Decided: Jan 20, 1999 after 226 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zielke-Ventral Derotation Spondylodesis: named in the summary without a submission number
- (no number) Kaneda SR™ Anterior Spinal System: named in the summary without a submission number
- (no number) Anterior Isola Spinal System: named in the summary without a submission number

## Most influential descendants
- K024125: Halm Zielke Instrumentation System (2003), 1 descendant of its own
- 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 such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.

Source page: https://510kreport.com/device/K982006
Methodology: https://510kreport.com/methodology