# K974345: Mitek Knotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: Feb 13, 1998 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 GII: named in the summary without a submission number

## Indications for use
Shoulder: Bankart repairSLAP Lesion repair acromio~clavicular separation, rotator cuff repair,capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis Elbow repair, biceps tendeon reattchment. Knee: Extra capsular repairs,Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, or joint capsule to tibia and joint capsult closnre to anterior proximal tibia, extra capsular reconstruction, ITBtenodesis, patellar ligament and tendon avulsions

Source page: https://510kreport.com/device/K974345
Methodology: https://510kreport.com/methodology