# K964013: Mitek Absorbable Toggle Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Feb 24, 1997 after 140 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
84 later devices descend from it; 5 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek® Stealth Anchor™: named in the summary without a submission number
- (no number) Mitek® Wedge Anchor: named in the summary without a submission number

## Most influential descendants
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own

## Indications for use
SHOULDER 1. Rotator Cuff repair. 2. Capsule shift/capsulo-labral reconstruction KNEE 1. Extra-capsular repairs and reattachment of: o medial collateral ligament o |ateral collateral ligament o _posterior obli ligament and joint capsule to tibia « _joint capsule closure to the anterior proximal tibia 2. Extra-capsular construction, ITB tenodesis 3. Patellar ligament and tendon avulsion repairs ANKLE 1. Achilles tendon repair/reconstruction

Source page: https://510kreport.com/device/K964013
Methodology: https://510kreport.com/methodology