510(k) · Cleared
ClearedImpact Suture Anchor. Model 433510
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 Apr 24, 2003 as substantially equivalent to K020056 (Bionx Implants, Ltd., 2002) and 23 other predicates after a 78-day review. Its family tree reaches back 5 generations to 1991. 77 later devices descend from it.
- Decided
- Apr 24, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 25
Its longest line of descent runs back 5 generations to K911837 (1991). 46 ancestors in all, the oldest K792022 (1979). 77 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 4 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 3 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 2 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 1 generation backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- This deviceK030388 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
- Descendant · 2 generations on · 25 of its ownK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- 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
- K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008 · 2 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −4 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −3 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −2 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −1 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K072291 | Conmed Linvatec Bio Mini-Revo Suture Anchor | Conmed Linvatec | 2008 | — |
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 |
|---|---|---|
| 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
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What was it cleared against? (25)
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 |
|---|---|---|---|
| * | K020056 | Duet Suture AnchorSummary page 1…the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. DuetTM Suture Anchor (K020056), SmartAnchor 1 (K972783),… | 2002 |
| * | K972783 | Biofix Biodegradable Threaded Suture AnchorSummary page 2…Bionx Implants Inc. DuetTM Suture Anchor (K020056), SmartAnchor 1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio… | 1998 |
| * | K973849 | Bioabsorbable Bankart TackSummary page 2…TM Suture Anchor (K020056), SmartAnchor 1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K… | 1998 |
| * | K992567 | Anatomical Bankart Tack, Model 523520ASummary page 2…rtAnchor 1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscr… | 1999 |
| * | K003970 | Contour Labral Nail, Model 533520ASummary page 2…1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture… | 2001 |
| * | K001378 | Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736Summary page 2…1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bi… | 2000 |
| * | K013057 | Biocuff,C, Models 236018, 236028, 236036Summary page 2…1 (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bio- Absorbable Corkscrew Su… | 2001 |
| * | K990361 | Headed Bio-Absorbable Corkscrew Model #AR-1921BUSummary page 2…ge 2 === (K972783), Bankart Tack (K973849), Contour Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bio- Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), In… | 1999 |
| * | K990987 | Bio-Absorbable Corkscrew, Model AR-1920BSummary page 2…r Labral Nail (K992567, K003970), BioCuffrM (K001378) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bio- Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 I), RC Mu… | 2000 |
| * | K003227 | Bio-Absorbable Corkscrew Model AR-1920BSummary page 2…8) and BioCuffrM C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bio- Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 I), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (… | 2001 |
| * | K990340 | Arthrex Pla Tissuetak, Model # AR-1940 BUSummary page 2…057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio- Absorbable Corkscrew Suture Anchor (K990987), Bio- Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 I), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Mak… | 2000 |
| * | K973381 | Bioroc EZ Suture Bone Fastener | 1998 |
| * | K992458 | RC Multisuture Bone Anchor, Model 4453/4454Summary page 2…uture Anchor (K990987), Bio- Absorbable Corkscrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K97338 I), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biolog~ically 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 I), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biolog~ically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvat… | 1999 |
| * | K963396 | Biosphere Suture AnchorSummary page 2…0), Innovasive Devices, Inc. BioROC EZ (K97338 I), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biolog~ically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) and Bio… | 1997 |
| * | K960555 | Bioasbsorbable Mini-Screw Suture AnchorSummary page 2…i-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biolog~ically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K95… | 1996 |
| * | K964805 | Bio-AnchorSummary page 2…chor (K984490), Instrument Makar, Inc,Biolog~ically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable… | 1997 |
| * | K963369 | Bio-AnchorSummary page 2…4490), Instrument Makar, Inc,Biolog~ically Quiet Biosphere (K963396) and Biologically Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) and BioRC Anchor (K9901 lo), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle An… | 1997 |
| * | K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor | 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…lly Quiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) 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…uture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K1983 186) 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…ation Bio-Anchor (K964805, K963369, K1983 186) 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 (K964921). Intended Use: The Bionx… | 1997 |
| * | K911837 | Suretac Polyglyconate Absorbable Fixation DeviceSummary page 2…3 186) 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 (K964921). Intended Use: The Bionx ImpactTM 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 |
| † | K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 | 1999 |
| † | K993453 | Meniscus Arrow, Models 531110, 531113, 531116 | 1999 |
| † | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025… | 1999 |
| † | K012001 | Smartscrew | 2001 |
| † | K000616 | Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828 | 2000 |
What descends from it? (77)
See all 772 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 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K042966 (Linvatec Biomaterials, Ltd., 2004) has gone furthest, with 76 descendants of its own.
- 2 other devices also cite its predicate K020056.
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 ImpactTM 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 (168 words)
The Bionx ImpactTM 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 ImpactTMSuture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, 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/K030388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030388: Impact Suture Anchor. Model 433510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030388
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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