# K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jun 9, 1997 after 90 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.
88 later devices descend from it; 9 cite it directly.
0 of 89 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 3.5mm Absorbable Suture Anchor System: 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
The Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative immobilization as follows: Open Procedures Shoulder: 1. Bankart repair 2. Slap lesion repair 3. Rotator cuff repair 4. a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation Elbow: 1. Bicep tendon reattachment Ankle: 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the talus site Knee: 1) Media! coliial ligament repair 2) Laieral collateral ligament repair 3) Joint capsule closure to the anterior proximal tibia 4) Posterior oblique ligament or joint capsule to tibia repair 5) Extra capsular reconstiuction/ITB tenodesis 6) Patellar ligament and tendon avulsion repairs Arthroscopic Procedures Shoulder: 1. Bankart repair 2. Slap lesion repair 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)

Source page: https://510kreport.com/device/K970896
Methodology: https://510kreport.com/methodology