510(k) · Cleared
ClearedCsco Forehead Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 28, 1997 as substantially equivalent to K926384 (Zimmer, Inc., 1993) and 4 other predicates after a 420-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 28, 1997
- Review
- 420 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K854886 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone Screws | Walter Lorenz Surgical, Inc. | 1986 | 1 |
| −1 | K961120 | Marker System for Stereotaxic Navigation | Howmedica Leibinger, Inc. | 1996 | — |
| 0 (this device) | K963502 | Csco Forehead Fixation System | Howmedica Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K926384 | Statak & Mini-Statak Soft Tissue Attachment DeviceSummary page 1…in the doctor’s office. Equivalence for this device is based upon similarities in intended use, material, design and operational principle to the Zimmer Statak Anchors (K926384), the Howmedica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094)… | 1993 |
| * | K953531 | Howmedica Mainstay AnchorSummary page 1…this device is based upon similarities in intended use, material, design and operational principle to the Zimmer Statak Anchors (K926384), the Howmedica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094), and the Marker System for Stereotaxic N… | 1995 |
| * | K912932 | Synthes Maxillofacial Titanium Micro SetSummary page 1…ntended use, material, design and operational principle to the Zimmer Statak Anchors (K926384), the Howmedica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094), and the Marker System for Stereotaxic Navigation (K961120). The Statak, Mainstay a… | 1991 |
| * | K961094 | Mitek Threaded Anchor (Modification) Cleared while this submission was under review Summary page 1…principle to the Zimmer Statak Anchors (K926384), the Howmedica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094), and the Marker System for Stereotaxic Navigation (K961120). The Statak, Mainstay and Mitek anchor devices are intended for use… | 1996 |
| * | K961120 | Marker System for Stereotaxic NavigationSummary page 1…dica Mainstay Anchor (K953531), the Synthes Cortical Bone Screw (K912932), the Mitek® Threaded 2.0 mm Anchor (K961094), and the Marker System for Stereotaxic Navigation (K961120). The Statak, Mainstay and Mitek anchor devices are intended for use in reattachment of soft tissue to bone; the Cortical Bone Sc… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 8 other devices also cite its predicate K926384.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
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…
Read the full statement (127 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963502 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963502: Csco Forehead Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963502
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026