510(k) · Cleared
Recalled · 2006Bioknotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on May 11, 2001 after a 260-day review. The FDA summary names its predicate without a number. 145 later devices descend from it. It has been recalled 2 times.
- Decided
- May 11, 2001
- Review
- 260 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 2
- Predicates
- 0
145 later devices descend from it, 6 citing it directly.
- This deviceK002639 Bioknotless AnchorMitek Products · 2001
- Descendant · cites it directly · 60 of its ownK040827 Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
- Descendant · 2 generations on · 59 of its ownK050771 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 · cites it directly · 50 of its ownK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K040827Panalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · cites it directly60descendants
- K050771Lupine LoopDepuy Mitek, A Johnson & Johnson Company · 2005 · 2 generations on59descendants
- 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
- K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006 · cites it directly50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002639 | Bioknotless Anchor | Mitek Products | 2001 | — |
| +1 | K040827 | Panalok Loop Anchor | Depuy Mitek, A Johnson & Johnson Company | 2004 | 17 |
| +2 | 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 |
| +1 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 14 | 0 |
| 2014 | 6 | 0 |
| 2015 | 12 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | — | Mitek - Knotless Anchor Named without a submission number | |
| * | — | Mitek - Panalok™ Wedge Anchor Named without a submission number |
What descends from it? (145)
See all 1456 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2006 | Not classified | Z-0610-06 | Other | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. |
| Feb 17, 2006 | Not classified | Z-0611-06 | Other | The inserter shafts bend, as they were manufactured with a different stainless steel than specified. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040827 (Depuy Mitek, A Johnson & Johnson Company, 2004) has gone furthest, with 60 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 Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot…
Read the full statement (100 words)
The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone
fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation,
rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis,
deltoid repair.
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction,
midfoot reconstruction.
Foot: Hallux Valgus reconstruction
Elbow: Tennis elbow repair, Biceps tendon reattachment.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K002639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002639: Bioknotless Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002639
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026