510(k) · Cleared
Recalled · Class II · 2012Nano Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corporation D/B/A Conmed Linvatec · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 2, 2011 as substantially equivalent to K091549 (Linvatec Corp., 2009) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1991. 9 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 2, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 10 generations to K911837 (1991). 75 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 6 generations between
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 1 generation backK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- This deviceK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011
- Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 2 of its ownK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK202153 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK190446 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
Show all 10 generations
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 8 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 7 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 6 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 5 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 4 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- 1 generation backK090835 Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
- This deviceK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
- K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019 · cites it directly2descendants
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 2 generations on1descendant
- K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020 · 2 generations on1descendant
- K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −9 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −8 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −7 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −6 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −5 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −4 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −3 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −2 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| −1 | K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CR | Linvatec Corp. | 2009 | — |
| 0 (this device) | K112965 | Nano Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2011 | — |
| +1 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +1 | K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019 | — |
| +2 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022 | — |
| +2 | K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2020 | — |
| +2 | K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K091549 | Conmed Linvatec Soft Tissue to Bone SystemSummary page 1…gally Marketed Devices Device Name: ConMed Linvatec Soft Tissue to Bone System Company Name: ConMed Linvatec 51 0(k) #: K091 549 Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor Company Name: ConMed Linvatec 51 0(k)… | 2009 |
| * | K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRSummary page 1…K091 549 Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor Company Name: ConMed Linvatec 51 0(k) ft: K090835 E. Device Description The ConMed Linvatec JVAAJOTM Suture Anchor is a device that is used to assist the surgeon in reattaching… | 2009 |
What descends from it? (9)
3 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 |
|---|---|---|---|---|
| Jun 26, 2012 | Class II | Z-0065-2013 | Process control | Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated… |
| Jun 26, 2012 | Class II | Z-0068-2013 | Process control | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the… |
| Jun 26, 2012 | Class II | Z-0063-2013 | Process control | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the… |
| Jun 26, 2012 | Class II | Z-0067-2013 | Process control | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the… |
| Jun 26, 2012 | Class II | Z-0064-2013 | Process control | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the… |
| Jun 26, 2012 | Class II | Z-0066-2013 | Process control | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 75 ancestors have a recall of any class.
- Of its descendants, K180951 (Responsive Arthroscopy, LLC, 2019) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K091549.
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 NANOTM Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint, capsules to the bone, The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular Ilabral repair and capsular repair in the hip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112965: Nano Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112965
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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