510(k) · Cleared
ClearedDuet Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Ltd. · HWC Screw, Fixation, Bone
Cleared on Jun 26, 2002 as substantially equivalent to K972783 (Bionx Implants, Inc., 1998) and 22 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1991. 78 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 169 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 24
Its longest line of descent runs back 4 generations to K911837 (1991). 45 ancestors in all, the oldest K792022 (1979). 78 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 3 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 2 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 1 generation backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- This deviceK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- Descendant · cites it directly · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- Descendant · cites it directly · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- Descendant · 2 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · 2 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- 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 · cites it directly76descendants
- K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · cites it directly75descendants
- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 2 generations on56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −3 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −2 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −1 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| 0 (this device) | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +1 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +1 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| +1 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| +2 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (24)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972783 | Biofix Biodegradable Threaded Suture AnchorSummary page 1…or use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. SmartAnchor (K972783), Bankart Tack (K973849), 1 === Page 2 ==… | 1998 |
| * | K973849 | Bioabsorbable Bankart TackSummary page 1…nt of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. SmartAnchor (K972783), Bankart Tack (K973849), 1 Contour Labral Nail (K… | 1998 |
| * | K992567 | Anatomical Bankart Tack, Model 523520ASummary page 2…rtAnchor (K972783), Bankart Tack (K973849), 1 Contour Labral Nail (K992567, K003970), BioCuffrM(K001378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew… | 1999 |
| * | K003970 | Contour Labral Nail, Model 533520ASummary page 2…(K972783), Bankart Tack (K973849), 1 Contour Labral Nail (K992567, K003970), BioCuffrM(K001378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture A… | 2001 |
| * | K001378 | Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736Summary page 2…ack (K973849), 1 Contour Labral Nail (K992567, K003970), BioCuffrM(K001378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio… | 2000 |
| * | K013057 | Biocuff,C, Models 236018, 236028, 236036 | 2001 |
| * | K990361 | Headed Bio-Absorbable Corkscrew Model #AR-1921BUSummary page 2…1 Contour Labral Nail (K992567, K003970), BioCuffrM(K001378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Inno… | 1999 |
| * | K990987 | Bio-Absorbable Corkscrew, Model AR-1920BSummary page 2…our Labral Nail (K992567, K003970), BioCuffrM(K001378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Mul… | 2000 |
| * | K003227 | Bio-Absorbable Corkscrew Model AR-1920BSummary page 2…378) and BioCuffrMC (KO13057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (… | 2001 |
| * | K990340 | Arthrex Pla Tissuetak, Model # AR-1940 BUSummary page 2…3057), Arthrex Inc. Bio-Absorbable Corkscrew (K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Mak… | 2000 |
| * | K973381 | Bioroc EZ Suture Bone FastenerSummary page 2…K99036 1) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396)… | 1998 |
| * | K992458 | RC Multisuture Bone Anchor, Model 4453/4454Summary page 2…Suture Anchor (K990987), Bio-Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw… | 1999 |
| * | K984490 | Sutureless AnchorSummary page 2…orbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvate… | 1999 |
| * | K963396 | Biosphere Suture AnchorSummary page 2…40), Innovasive Devices, Inc. BioROC EZ (K97338 1), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC… | 1997 |
| * | K960555 | Bioasbsorbable Mini-Screw Suture AnchorSummary page 2…ti-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K9502… | 1996 |
| * | K964805 | Bio-AnchorSummary page 2…nchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable To… | 1997 |
| * | K963369 | Bio-AnchorSummary page 2…84490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anch… | 1997 |
| * | K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorSummary page 2…nstrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K9640… | 1998 |
| Kept off the family tree | K990110 | FDA’s K990110 is Disposable Ecg Monitoring Electrodes, Model 4110, 4140 Our reading of the summary gave K990110, FDA’s number for Disposable Ecg Monitoring Electrodes, Model 4110, 4140 (Maersk Medical A/S). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioRC Anchor”. Kept off the family tree. | 1999 |
| * | K950272 | Panalok Absorbable Suture Anchor SystemSummary page 2…cally Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex-Inc. Suretac 6.0, 8,O (K911837) and DePuy Inc. De Puy Dupon… | 1996 |
| * | K970896 | Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemSummary page 2…Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex-Inc. Suretac 6.0, 8,O (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Ancho… | 1997 |
| * | K964013 | Mitek Absorbable Toggle AnchorSummary page 2…oration Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex-Inc. Suretac 6.0, 8,O (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K96492 1). Intended Use: The Bionx… | 1997 |
| * | K911837 | Suretac Polyglyconate Absorbable Fixation DeviceSummary page 2…83186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex-Inc. Suretac 6.0, 8,O (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K96492 1). Intended Use: The Bionx DuetTM Suture Anchor is a bioabsorbale… | 1991 |
| * | K964521 | Depuy Dupont Phantom Suture Anchor Our reading of the summary gave K964921, FDA’s number for Basic Biopsy Tray. Disposable, Sterile (Trinity Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “De Puy Dupont Phantom Suture Anchor”. | 1997 |
What descends from it? (78)
See all 783 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 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 45 ancestors have a recall of any class.
- Of its descendants, K030388 (Bionx Implants, Ltd., 2003) has gone furthest, with 77 descendants of its own.
- 2 other devices also cite its predicate K972783.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Bionx DuetTM Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device 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…
Read the full statement (166 words)
The Bionx DuetTM Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device 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.
The Bionx DuetTM Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3)Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5 ) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6)Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020056: Duet 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/K020056
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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