510(k) · Cleared
ClearedNanotack Suture Anchor 1.4MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pivot Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 25, 2011 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 2 other predicates after a 96-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 96 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K961555 (1996). 38 ancestors in all, the oldest K813581 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- This deviceK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
- Descendant · cites it directly · 0 of its ownK130351 Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK123651 Cinchlock Knotless Suture AnchorPivot Medical · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| 0 (this device) | K110473 | Nanotack Suture Anchor 1.4MM | Pivot Medical | 2011 | — |
| +1 | K130351 | Nanotack Suture Anchor 1.4MM with Flex Inserter | Pivot Medical, Inc. | 2013 | — |
| +1 | K123651 | Cinchlock Knotless Suture Anchor | Pivot Medical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 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? (3)
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 |
|---|---|---|---|
| * | K071586 | Bioraptor 2.3 PK Suture AnchorSummary page 1…aded metallic bone fixation fastener Regulation number: 21 CFR8S8.3040 Product Code: MBI Predicate Devices Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586 Biomet Sleeve with ZipLoopTM Fixation Device - K080088 and K101063 Device Description The Pivot NanoTack Suture Anchor is a no… | 2007 |
| * | K080088 | Biomet Sports Medicine Anchor Devices and Ziploop ConstructsSummary page 1…21 CFR8S8.3040 Product Code: MBI Predicate Devices Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586 Biomet Sleeve with ZipLoopTM Fixation Device - K080088 and K101063 Device Description The Pivot NanoTack Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA… | 2008 |
| * | K101063 | Sleeve with Ziploop Fixation DevicesSummary page 1…8.3040 Product Code: MBI Predicate Devices Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586 Biomet Sleeve with ZipLoopTM Fixation Device - K080088 and K101063 Device Description The Pivot NanoTack Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer at… | 2010 |
What descends from it? (2)
2 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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K130351 (Pivot Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 22 other devices also cite its predicate K071586.
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. 2011, 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 NanoTack Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110473: Nanotack Suture Anchor 1.4MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110473
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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