510(k) · Cleared
ClearedDunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dunamis, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 6, 2016 as substantially equivalent to K082215 (Smith & Nephew Inc., Endoscopy Division, 2008) and 1 other predicate after an 89-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Jul 6, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K961555 (1996). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- 1 generation backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- This deviceK160996 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC · 2016
- Descendant · cites it directly · 0 of its ownK193245 Dunamis PunchTac Suture AnchorsDunamis, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K193245Dunamis PunchTac Suture AnchorsDunamis, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| −1 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| 0 (this device) | K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Dunamis, LLC | 2016 | — |
| +1 | K193245 | Dunamis PunchTac Suture Anchors | Dunamis, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (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 |
|---|---|---|---|
| * | K082215 | Osteoraptor Suture AnchorSummary page 4…equivalent in Intended use and performance to the following legally marketed devices in commercial distribution: Smith & Nephew Osteoraptor 2.3 Suture Anchor K082215, Smith & Nephew Twinfix PK FT Suture Anchor K072785 . E. Description of Device The Dunamis Suture Anchor is a sterile s… | 2008 |
| * | K072785 | Twinfix FT PKSummary page 4…following legally marketed devices in commercial distribution: Smith & Nephew Osteoraptor 2.3 Suture Anchor K082215, Smith & Nephew Twinfix PK FT Suture Anchor K072785 . E. Description of Device The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193245 | Dunamis PunchTac Suture Anchors | 2020 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K193245 (Dunamis, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K082215.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Elbow, Wrist, and Hand Capsular Stabilization Ulnar or radial collateral ligament reconstructions - Bankart Repair Lateral epicondylitis repair - Anterior Shoulder Instability Biceps tendon reattachment - SLAP lesion repairs - Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs…
Read the full statement (117 words)
The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to
bone for the following indications:
Shoulder Elbow, Wrist, and Hand
Capsular Stabilization Ulnar or radial collateral ligament reconstructions
- Bankart Repair Lateral epicondylitis repair
- Anterior Shoulder Instability Biceps tendon reattachment
- SLAP lesion repairs
- Capsular Shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid Repairs
Rotator Cuff tear repairs
Biceps tenodesis Knee
Extra-capsular repairs:
- medial collateral ligament
- lateral collateral ligament
- posterior oblique ligament
Patellar realignment and tendon repairs:
Foot and Ankle - vastus medialis obliquous advancement
Hallux vaigus repairs lliotibial band tenodesis
Medial or lateral instablility
repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon
repairsi/reconstructions
Bunionectomy
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/K160996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160996: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160996
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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