510(k) · Cleared
ClearedCincher-2.6 Suture Anchor Model FG-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foundry Newcoxi, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 19, 2012 after an 85-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 19, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (3)
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 |
|---|---|---|---|
| * | — | Bioraptor 2.3 PK Named without a submission number | |
| * | — | PushLock Named without a submission number | |
| * | — | Force Fiber Named without a submission number |
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.
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. 2012, this device’s year, is highlighted.
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 Foundry NewcoXl Cincber-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair; Acetabular labrum reattachment Shoulder: Capsular stabilization; Bankart repair; Anterior shoulder instability; SLAP lesion repairs; Capsular shift or capsulolabral reconstructions; Acromioclavicular separation repairs; Deltoid repairs; Rotator cuff tear repairs; Biceps tenoddsis Foot and Ankle…
Read the full statement (131 words)
The Foundry NewcoXl Cincber-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Hip: Hip capsule repair; Acetabular labrum reattachment
Shoulder: Capsular stabilization; Bankart repair; Anterior shoulder instability; SLAP lesion repairs; Capsular shift or capsulolabral reconstructions; Acromioclavicular separation repairs; Deltoid repairs; Rotator cuff tear repairs; Biceps tenoddsis
Foot and Ankle: Hallux valgus repairs; Medial or lateral instability repairs/reconstructions; Achilles tendon repairs/reconstructions; Midfoot reconstructions; Metatarsal ligament/tendon repairs/reconstruction; Bunionectomy
Elbow, Wrist and Hand: Biceps tendon reattachment; Ulnar or radial collateral ligament reconstructions; Lateral epicondylitis repair; Tennis elbow repair; Scapholunate ligament reconstruction
Knee: Extra-capsular repairs: Medial collateral ligament; Lateral collateral ligament; Posterior oblique ligament; Patellar realignment and tendon repairs; Vastus medialis obliquous advancement; liotibial band tenodesis
The Foundry NewcoXil Cincher-2.6 Suture Anchor is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122954: Cincher-2.6 Suture Anchor Model FG-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122954
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026