510(k) · Cleared
ClearedLupine Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Apr 8, 2005 as substantially equivalent to K040827 (Depuy Mitek, A Johnson & Johnson Company, 2004) after a 14-day review. Its family tree reaches back 2 generations to 2001. 59 later devices descend from it.
- Decided
- Apr 8, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002639 (2001). 59 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002639 Bioknotless AnchorMitek Products · 2001 · Recalled
- 1 generation backK040827 Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- This deviceK050771 Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005
- Descendant · cites it directly · 58 of its ownK062170 Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006 · Recalled
- Descendant · 2 generations on · 57 of its ownK070925 Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · Recalled
- Descendant · 3 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- Descendant · 4 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
- Descendant · 4 generations on · 24 of its ownK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K062170Bioknotless and Lupine Plus AnchorsDepuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly58descendants
- K070925Modification to: Bioknotless BR Anchor / Lupine BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2007 · 2 generations on57descendants
- K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 3 generations on44descendants
- K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · 4 generations on25descendants
- K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company · 2010 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002639 | Bioknotless Anchor | Mitek Products | 2001 | 2 |
| −1 | K040827 | Panalok Loop Anchor | Depuy Mitek, A Johnson & Johnson Company | 2004 | 17 |
| 0 (this device) | K050771 | Lupine Loop | Depuy Mitek, A Johnson & Johnson Company | 2005 | — |
| +1 | K062170 | Bioknotless and Lupine Plus Anchors | Depuy Mitek, A Johnson & Johnson Company | 2006 | 7 |
| +2 | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2007 | 11 |
| +3 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| +4 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| +4 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K040827 | Panalok Loop AnchorSummary page 1…Lupine Loop System Substantial Equivalence Lupine Loop Anchor is substantially equivalent to: Panalok Loop Anchor, K040827, manufactured by DePuy Mitek. Device Classification Bone anchors/screws are classified by the FDA as Class II Medic… | 2004 |
What descends from it? (59)
See all 591 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062170 | Bioknotless and Lupine Plus Anchors | 2006 | 58 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K062170 (Depuy Mitek, A Johnson & Johnson Company, 2006) has gone furthest, with 58 descendants of its own.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
The Lupine 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 (162 words)
The Lupine 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/K050771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050771: Lupine Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050771
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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