510(k) · Cleared
ClearedPanalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Miltek, A Johnson & Johnson Co. · JDR Staple, Fixation, Bone
Cleared on Nov 22, 2006 as substantially equivalent to K041117 (Depuy Mitek, 2004) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Nov 22, 2006
- Review
- 23 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964013 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK964013 Mitek Absorbable Toggle AnchorMitek Products · 1997
- 1 generation backK041117 Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture…Depuy Mitek · 2004
- This deviceK063273 Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture…Depuy Miltek, A Johnson & Johnson Co. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964013 | Mitek Absorbable Toggle Anchor | Mitek Products | 1997 | — |
| −1 | K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC… | Depuy Mitek | 2004 | — |
| 0 (this device) | K063273 | Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok… | Depuy Miltek, A Johnson & Johnson Co. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…Summary page 1…Quickanchor Plus Dual Suture (with ORTHOCORD) are substantially equivalent to: Panalok RC Quickanchor Plus, K041117, manufactured by DePuy Mitek. Panalok Anchor (with ORTHOCORD) is sub… | 2004 |
| * | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemSummary page 1…Mitek. Panalok Anchor (with ORTHOCORD) is substantially equivalent to: Panalok Anchor, K970896, manufactured by DePuy Mitek. Device Classification Bone anchors/screws are classified by the FDA as Class 11 Medical… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (166 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063273: Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026