510(k) · Cleared
ClearedDuet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Nov 19, 2004 as substantially equivalent to K020056 (Bionx Implants, Ltd., 2002) and 1 other predicate after a 22-day review. Its family tree reaches back 6 generations to 1991. 76 later devices descend from it.
- Decided
- Nov 19, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911837 (1991). 47 ancestors in all, the oldest K792022 (1979). 76 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 5 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 4 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 3 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 2 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 1 generation backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- This deviceK042966 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
- Descendant · 2 generations on · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
- Descendant · 3 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- 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
- K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · 2 generations on25descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −5 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −4 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −3 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −2 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −1 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
| +3 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
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 |
|---|---|---|
| 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K020056 | Duet Suture AnchorSummary page 1…Linvatec Biomaterials Modification of DuetTM and ImpactTM Suture Anchor (K020056, K030388) Submitter's Name, Address, Telephone Number, and Contact Person Linvatec Biomaterials Ltd.… | 2002 |
| * | K030388 | Impact Suture Anchor. Model 433510Summary page 1…Linvatec Biomaterials Modification of DuetTM and ImpactTM Suture Anchor (K020056, K030388) Submitter's Name, Address, Telephone Number, and Contact Person Linvatec Biomaterials Ltd.… | 2003 |
What descends from it? (76)
See all 762 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 13 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 47 ancestors have a recall of any class.
- Of its descendants, K053561 (Conmed Linvatec, 2006) has gone furthest, with 75 descendants of its own.
- 2 other devices also cite its predicate K020056.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
DuetTM and ImpactTM Suture Anchors are 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 (169 words)
DuetTM and ImpactTM Suture Anchors are 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 DuetTM and Impact TM Suture Anchors are 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/K042966 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042966
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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