510(k) · Cleared
ClearedPanalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek · JDR Staple, Fixation, Bone
Cleared on May 28, 2004 as substantially equivalent to K964013 (Mitek Products, 1997) after a 29-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- May 28, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964013 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK964013 Mitek Absorbable Toggle AnchorMitek Products · 1997
- This deviceK041117 Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture…Depuy Mitek · 2004
- Descendant · cites it directly · 0 of its ownK063273 Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture…Depuy Miltek, A Johnson & Johnson Co. · 2006
Most influential descendants
Showing 1 of 1 · See all- K063273Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok AnchorDepuy Miltek, A Johnson & Johnson Co. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964013 | Mitek Absorbable Toggle Anchor | Mitek Products | 1997 | — |
| 0 (this device) | K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC… | Depuy Mitek | 2004 | — |
| +1 | K063273 | Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok… | Depuy Miltek, A Johnson & Johnson Co. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K964013 | Mitek Absorbable Toggle AnchorSummary page 2…lymer. Substantial Equivalence Based on the degree of changes being made to the original Mitek Absorbable Toggle Anchor (K964013) and the fact that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063273 | Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok Anchor | 2006 | 0 |
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?
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 Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are intended for fixation of USP size #2 suture to bone for the indication listed below.
Shoulder: Rotator cuff repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041117: Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor Pllus, Models 212132, 212732.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041117
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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