# K102406: Pass Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea Technologies
- Decided: Aug 23, 2011 after 364 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: 2 generations back to K782061 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982011: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K024125: Halm Zielke Instrumentation System, Micomed Ortho GmbH (2003) Summary page 1.

## Indications for use
The PASS Anterior Spinal Systems is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to LS in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine: * Degenerative disc disease (DOD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Traumatism (ex: fracture, dislocation) * Tumor * Spinal deformation such as scoliosis or kyphosis * Failed previous fusion (Pseudoarthrosis)

Source page: https://510kreport.com/device/K102406
Methodology: https://510kreport.com/methodology