# K040827: Panalok Loop Anchor

- Pathway: 510(k) (Special)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Apr 30, 2004 after 31 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002639 (2001). 1 ancestor in all.
60 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002639: Bioknotless Anchor, Mitek Products (2001) Summary page 1.

## Most influential descendants
- 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
- K073412: Gryphon BR and Healix BR Anchors (2008), 44 descendants of its own
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 (2009), 25 descendants of its own

## Recalls of this device
- Apr 13, 2023 · Class II · Z-1678-2023: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the pati
- Apr 13, 2023 · Class II · Z-1679-2023: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the pati
- Apr 13, 2023 · Class II · Z-1680-2023: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the pati
- Apr 13, 2023 · Class II · Z-1677-2023: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the pati
- Apr 13, 2023 · Class II · Z-1681-2023: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the pati
- Jan 27, 2012 · Not classified · Z-1162-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1170-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1166-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1168-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1169-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1167-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1163-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1165-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1164-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Jan 27, 2012 · Not classified · Z-1171-2012: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- Oct 31, 2011 · Not classified · Z-0318-2012: Incorrect suture configuration
- Oct 31, 2011 · Not classified · Z-0314-2012: Incorrect suture configuration

## Indications for use
The PANALOK Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW 1. Biceps tendon reattachment 2. Tennis elbow repair ANKLE 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction/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/K040827
Methodology: https://510kreport.com/methodology