# K063273: Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok Anchor

- Pathway: 510(k) (Special)
- Applicant: Depuy Miltek, A Johnson & Johnson Co.
- Decided: Nov 22, 2006 after 23 days
- Product code: JDR (Staple, Fixation, Bone)
- 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
Longest line of descent: 2 generations back to K964013 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041117: Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732, Depuy Mitek (2004) Summary page 1.
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System, ETHICON, Inc. (1997) Summary page 1.

## Indications for use
The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: rotator cuff repair The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:. Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, , biceps tenodesis, acromio-clavicular separation. Elbow: Biceps tendon reattachment Ankle: Achilles tendon repair/reconstruction, lateral stabilization, medial stabilization at the medial talus site Knee: Medial collateral ligament repair, lateral collateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITB tenodesis, patellar ligament and tendon avulsion repairs Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair,, capsule shift repair (glenoid rim)

Source page: https://510kreport.com/device/K063273
Methodology: https://510kreport.com/methodology