510(k) · Cleared
ClearedKinsa Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 8, 2006 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) after a 43-day review. Its family tree reaches back 3 generations to 1996. 162 later devices descend from it.
- Decided
- Jun 8, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961555 (1996). 4 ancestors in all. 162 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- This deviceK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 121 of its ownK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- Descendant · cites it directly · 60 of its ownK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
- Descendant · 2 generations on · 59 of its ownK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
- Descendant · 2 generations on · 46 of its ownK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
Showing 5 of 162 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 162 · See all- K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · cites it directly121descendants
- K070908Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · cites it directly60descendants
- K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007 · 2 generations on59descendants
- K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · 2 generations on46descendants
- K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · 2 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −2 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −1 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| +1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| +1 | K070908 | Smith & Nephew Kinsa RC Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| +2 | K072785 | Twinfix FT PK | Smith & Nephew Inc., Endoscopy Division | 2007 | — |
| +2 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| +2 | K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 17 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew BIORAPTOR Suture Anchor (K053344). 17… | 2006 |
What descends from it? (162)
See all 1623 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)
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 10 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) has gone furthest, with 121 descendants of its own.
- 15 other devices also cite its predicate K053344.
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.
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 Smith & Nephew KINSA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization
Bankhart Repair
Anterior Shoulder Instability Repair
SLAP Lesion Repairs
Capsular Shift of capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid Repairs
Rotator Cuff Tear repairs
Biceps tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061154: Kinsa Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061154
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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