# K201240: Mariner Cap System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Aug 5, 2020 after 89 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K040583 (2004). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP, Implanet, S.A. (2019) Summary page 4.

## Indications for use
The Mariner Cap System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K201240
Methodology: https://510kreport.com/methodology