# K990657: Trifix Pedicle Spinal Screw Assembly - Pathway: 510(k) (Special) - Applicant: Corin USA - Decided: Mar 26, 1999 after 25 days - Product code: MNH (Orthosis, Spondylolisthesis Spinal 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 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. FDA’s file for it is a 510(k) statement, which names no predicate. ## Indications for use 1. ‘The device syste consisting scrcws, washers, spacers, utilizing the anterotateralanterior surgical approach is intended for the following uses: (a) antcrolateral screw fixation to the non-cervical spine, (b) anteriar screw fixution ta the cervical spine The anterolateral/anterior system is intended for use in the following indications: (1) Degenerative disc diseasc of the Jumbur thoracic and cervical spine relating to discogenic arigin with degeneration of the disc as confirmed by patient history and radiographic studics. (b) Spondylolisthesis (<) Trauma (d) Spinal Stenosis (e} Scalivsis {t) Kyphosis (¢} Tumor (h) Pseudoarthrosts (1) Revision of previous surgery (j) Ncoplastia 2. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle posterior systent has the follawing intended uve: (2) hook aad sucral/tliac screw fixation ta the non-cervical spinc The non-pedicle posterior devices may be used for the followiag indications: (1) Degenerative disc discase of the Jumbar thoracic and ccrvical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic swdies. (b) Spondylolisthesis (<) Treawmna (d) Spinal Stenosis @ n-Off) (¢) Scoliosix (Division\\ig Division of General (!) K)’phu.\'i.\" 510) Nomber """""‘"""was? {e) Tuwinor (h) Pscudouarthrosis (1) Revision of previous surgery Q) Necoplastia 3. The device system consisting of hooks, spaccrs, sacral/iliac screws and pedicle screws is intended for paticnts: (a) Having a scvere spondyloslisthesis (grades 3 and 4) at the [.5-S1 joint (b) Who are reeciving fusions using autogenous bone graft only (¢) Who are having the device [ixed or attached 10 the tumbar and