# K963502: Csco Forehead Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 28, 1997 after 420 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K854886 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 1.
- K953531: Howmedica Mainstay Anchor, Howmedica Corp. (1995) Summary page 1.
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) Summary page 1.
- K961094: Mitek Threaded Anchor (Modification), Mitek Products (1996). Cleared while this submission was under review Summary page 1.
- K961120: Marker System for Stereotaxic Navigation, Howmedica Leibinger, Inc. (1996) Summary page 1.

## Indications for use
The CSCO Forehead Fixation System is intended for use in an endoscopic forehead or brow lift procedure. This procedure is performed endoscopically through several small openings rather than through a trans-coronal incision, resulting in reduced scarring and blood loss for patients. The soft tissue is elevated off the underlying bone endoscopically and fixed in the higher position by tying sutures attached to the tissue of the scalp to the CSCO Forehead Fixation System anchored in the outer table of the skull. The CSCO Forehead Fixation System is attached to the skull through a small incision in the scalp. It is recommended that the CSCO Forehead Fixation System be removed after approximately 10-14 days to allow adherence of the newly elevated soft tissues to the underlying frontal bone.

Source page: https://510kreport.com/device/K963502
Methodology: https://510kreport.com/methodology