510(k) · Cleared
Recalled · Class II · 2023Panalok Loop Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Apr 30, 2004 as substantially equivalent to K002639 (Mitek Products, 2001) after a 31-day review. Its family tree reaches back 1 generation to 2001. 60 later devices descend from it. It has been recalled 17 times.
- Decided
- Apr 30, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002639 (2001). 60 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002639 Bioknotless AnchorMitek Products · 2001 · Recalled
- This deviceK040827 Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004
- Descendant · cites it directly · 59 of its ownK050771 Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005
- Descendant · 2 generations on · 58 of its ownK062170 Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006 · Recalled
- Descendant · 3 generations on · 57 of its ownK070925 Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · Recalled
- Descendant · 4 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- Descendant · 5 generations on · 25 of its ownK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K050771Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005 · cites it directly59descendants
- K062170Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006 · 2 generations on58descendants
- K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · 3 generations on57descendants
- K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 4 generations on44descendants
- K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · 5 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002639 | Bioknotless Anchor | Mitek Products | 2001 | 2 |
| 0 (this device) | K040827 | Panalok Loop Anchor | Depuy Mitek, A Johnson & Johnson Company | 2004 | — |
| +1 | K050771 | Lupine Loop | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| +2 | K062170 | Bioknotless and Lupine Plus Anchors | Depuy Mitek, A Johnson & Johnson Company | 2006 | 7 |
| +3 | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2007 | 11 |
| +4 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| +5 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K002639 | Bioknotless AnchorSummary page 1…ok Loop Anchor Substantial Equivalence The Panalok Loop Anchor is substantially equivalent to the BioKnotless Anchor (K002639) and has similar indications to PANALOK Anchor System (K970896) manufactured by DePuy… | 2001 |
| † | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System | 1997 |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050771 | Lupine Loop | 2005 | 59 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2023 | Class II | Z-1678-2023 | Use error | 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 patient. broken BIOKNOTLESS¿ Anchor… |
| Apr 13, 2023 | Class II | Z-1679-2023 | Use error | 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 patient. broken BIOKNOTLESS¿ Anchor… |
| Apr 13, 2023 | Class II | Z-1680-2023 | Use error | 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 patient. broken BIOKNOTLESS¿ Anchor… |
| Apr 13, 2023 | Class II | Z-1677-2023 | Use error | 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 patient. broken BIOKNOTLESS¿ Anchor… |
| Apr 13, 2023 | Class II | Z-1681-2023 | Use error | 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 patient. broken BIOKNOTLESS¿ Anchor… |
| Jan 27, 2012 | Not classified | Z-1162-2012 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Employee error | Incorrect suture configuration |
| Oct 31, 2011 | Not classified | Z-0314-2012 | Employee error | Incorrect suture configuration |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040827: Panalok Loop Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040827
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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