# K002639: Bioknotless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Products
- Decided: May 11, 2001 after 260 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
145 later devices descend from it; 6 cite it directly.
0 of 146 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 - Knotless Anchor: named in the summary without a submission number
- (no number) Mitek - Panalok™ Wedge Anchor: named in the summary without a submission number

## Most influential descendants
- K040827: Panalok Loop Anchor (2004), 60 descendants of its own
- K050771: Lupine Loop (2005), 59 descendants of its own
- K062170: Bioknotless and Lupine Plus Anchors (2006), 58 descendants of its own
- K070925: Modification to: Bioknotless BR Anchor / Lupine BR Anchor (2007), 57 descendants of its own
- K061349: Opus Labralock P Knotless Fixation Device (2006), 50 descendants of its own

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0610-06: The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- Feb 17, 2006 · Not classified · Z-0611-06: The inserter shafts bend, as they were manufactured with a different stainless steel than specified.

## Indications for use
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral 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 tendon reattachment. Knee: Extra capsular repairs, reattachment of: Medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Source page: https://510kreport.com/device/K002639
Methodology: https://510kreport.com/methodology