510(k) · Cleared
ClearedMitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jun 9, 1997 after a 90-day review. The FDA summary names its predicate without a number. 88 later devices descend from it.
- Decided
- Jun 9, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
88 later devices descend from it, 9 citing it directly.
- This deviceK970896 Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemETHICON, Inc. · 1997
- Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · cites it directly77descendants
- K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 2 generations on76descendants
- K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System | ETHICON, Inc. | 1997 | — |
| +1 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +1 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +2 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| +2 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| +3 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 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 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 |
|---|---|---|---|
| * | — | Mitek 3.5mm Absorbable Suture Anchor System Named without a submission number |
What descends from it? (88)
See all 889 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020056 | Duet Suture Anchor | 2002 | 78 |
| K030388 | Impact Suture Anchor. Model 433510 | 2003 | 77 |
| K120824 | 3.9MM Reelx STT Suture Anchor System | 2012 | 1 |
| K051362 | Inion Anchron Biodegradable Anchor System, Model Anc-6000 | 2005 | 1 |
| K023013 | Stryker Xcel Anchor System | 2003 | 1 |
| K070347 | Allofix Push-in Anchor | 2007 | 0 |
| K063273 | Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok Anchor | 2006 | 0 |
| K032072 | Lactosorb L15 Screw Anchor with Lactocarbonate Suture | 2003 | 0 |
| K993575 | Resolve Quickanchor | 1999 | 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?
- Of its descendants, K020056 (Bionx Implants, Ltd., 2002) has gone furthest, with 78 descendants of its own.
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 Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative immobilization as follows: Open Procedures Shoulder: 1. Bankart repair 2. Slap lesion repair 3. Rotator cuff repair 4. a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5.…
Read the full statement (153 words)
The Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative immobilization as follows:
Open Procedures
Shoulder:
1. Bankart repair
2. Slap lesion repair
3. Rotator cuff repair
4. a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
5. Biceps tenodesis
6. Acromio-clavicular separation
Elbow:
1. Bicep tendon reattachment
Ankle:
1. Achilles tendon repair/reconstruction
2. Lateral stabilization
3. Medial stabilization at the talus site
Knee:
1) Media! coliial ligament repair
2) Laieral collateral ligament repair
3) Joint capsule closure to the anterior proximal tibia
4) Posterior oblique ligament or joint capsule to tibia repair
5) Extra capsular reconstiuction/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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970896 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970896
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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