# K021275: Micomed Posterior Doublerod System

- Pathway: 510(k) (Traditional)
- Applicant: Micomed Ortho GmbH
- Decided: Jul 18, 2002 after 87 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851834 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974745: Manan Gwi Guide Wire Introducer, Medical Device Technologies, Inc. (1998) Summary page 2.
- K984378: Depuy Acromed Moss Spinal System, Depuy, Inc. (1998) Summary page 1.

## Indications for use
The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis with objective evidence of neurological impairment, fiacture, dislocation, scoiiosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scoliosis, Scheuerrnann’s disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.

Source page: https://510kreport.com/device/K021275
Methodology: https://510kreport.com/methodology