510(k) · Cleared
ClearedSuper Quickanchor Plus (with Orthocord Suture)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · JDR Staple, Fixation, Bone
Cleared on Oct 21, 2005 as substantially equivalent to K041116 (Depuy Mitek, 2004) after a 25-day review. Its family tree reaches back 2 generations to 1993. 22 later devices descend from it.
- Decided
- Oct 21, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930893 (1993). 22 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930893 Mitek Super Quickanchor, ModificationMitek Surgical Products, Inc. · 1993
- 1 generation backK041116 Super Quickanchor PlusDepuy Mitek · 2004
- This deviceK052631 Super Quickanchor Plus (with Orthocord Suture)Depuy Mitek, A Johnson & Johnson Company · 2005
- Descendant · cites it directly · 21 of its ownK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
- Descendant · 2 generations on · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · 3 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · 4 generations on · 3 of its ownK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008 · cites it directly21descendants
- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on15descendants
- K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 3 generations on6descendants
- K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 3 generations on6descendants
- K222091Grappler Suture Anchor SystemParagon 28, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930893 | Mitek Super Quickanchor, Modification | Mitek Surgical Products, Inc. | 1993 | — |
| −1 | K041116 | Super Quickanchor Plus | Depuy Mitek | 2004 | — |
| 0 (this device) | K052631 | Super Quickanchor Plus (with Orthocord Suture) | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| +1 | K082282 | Healix TI Anchor | Depuy Mitek, A Johnson & Johnson Co. | 2008 | — |
| +2 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +3 | K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | 2021 | 1 |
| +3 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +4 | K222091 | Grappler Suture Anchor System | Paragon 28, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K041116 | Super Quickanchor PlusSummary page 1…Super Quickanchor Plus (with ORTILOCORD) is substantially equivalent to: Super Quickanchor Plus, K041116, manufactured by DePuy Muck. Device Classification Bone anchors/screws are classified by the FDA as Class 11 Medica… | 2004 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082282 (Depuy Mitek, A Johnson & Johnson Co., 2008) has gone furthest, with 21 descendants of its own.
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 Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.
Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.
Ankle: Achilles tendon repair/reconstruction.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis: patellar ligament and tendon avulsions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052631: Super Quickanchor Plus (with Orthocord Suture).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052631
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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