# K031772: TI Fenestrated Plate

- Pathway: 510(k) (Abbreviated)
- Applicant: Interpore Cross Intl.
- Decided: Sep 5, 2003 after 88 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Ti Fenestrated Plate is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The Ti Fenestrated Plate is intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The Ti Fenestrated Plate is attached to the spine posteriorly by means of Songer Cables. The levels of attachment are T1 to L5. The Ti Fenestrated Plate is indicated for the following: 1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Idiopathic scoliosis. 3. Kyphotic deformities of the spine. 4. Lordotic deformities of the spine. 5. Vertebral fracture or dislocation. 6. Tumors. 7. Spondylolisthesis. 8. Stenosis. 9. Pseudarthrosis. 10. Unsuccessful previous attempts at spinal fusion.

Source page: https://510kreport.com/device/K031772
Methodology: https://510kreport.com/methodology