# K030388: Impact Suture Anchor. Model 433510

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Ltd.
- Decided: Apr 24, 2003 after 78 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911837 (1991). 46 ancestors in all.
77 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020056: Duet Suture Anchor, Bionx Implants, Ltd. (2002) Summary page 1.
- K972783: Biofix Biodegradable Threaded Suture Anchor, Bionx Implants, Inc. (1998) Summary page 2.
- K973849: Bioabsorbable Bankart Tack, Hogan & Hartson (1998) Summary page 2.
- K992567: Anatomical Bankart Tack, Model 523520A, Bionx Implants, Ltd. (1999) Summary page 2.
- K003970: Contour Labral Nail, Model 533520A, Bionx Implants, Inc. (2001) Summary page 2.
- K001378: Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736, Bionx Implants, Inc. (2000) Summary page 2.
- K013057: Biocuff,C, Models 236018, 236028, 236036, Bionx Implants, Inc. (2001) Summary page 2.
- K990361: Headed Bio-Absorbable Corkscrew Model #AR-1921BU, Arthrex, Inc. (1999) Summary page 2.
- K990987: Bio-Absorbable Corkscrew, Model AR-1920B, Arthrex, Inc. (2000) Summary page 2.
- K003227: Bio-Absorbable Corkscrew Model AR-1920B, Arthrex, Inc. (2001) Summary page 2.
- K990340: Arthrex Pla Tissuetak, Model # AR-1940 BU, Arthrex, Inc. (2000) Summary page 2.
- K973381: Bioroc EZ Suture Bone Fastener, Innovasive Devices, Inc. (1998)
- K992458: RC Multisuture Bone Anchor, Model 4453/4454, Innovasive Devices, Inc. (1999) Summary page 2.
- K984490: Sutureless Anchor, Innovasive Devices, Inc. (1999) Summary page 2.
- K963396: Biosphere Suture Anchor, Instrument Makar, Inc. (1997) Summary page 2.
- K960555: Bioasbsorbable Mini-Screw Suture Anchor, Instrument Makar, Inc. (1996) Summary page 2.
- K964805: Bio-Anchor, Linvatec Corp. (1997) Summary page 2.
- K963369: Bio-Anchor, Linvatec Corp. (1997) Summary page 2.
- K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor, Linvatec Corp. (1998)
- K950272: Panalok Absorbable Suture Anchor System, ETHICON, Inc. (1996) Summary page 2.
- K970896: Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System, ETHICON, Inc. (1997) Summary page 2.
- K964013: Mitek Absorbable Toggle Anchor, Mitek Products (1997) Summary page 2.
- K911837: Suretac Polyglyconate Absorbable Fixation Device, Acufex Microsurgical, Inc. (1991) Summary page 2.
- K964521: Depuy Dupont Phantom Suture Anchor, Depuy, Inc. (1997). 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”.

## Cited in the summary but kept off the family tree
- K990110: Disposable Ecg Monitoring Electrodes, Model 4110, 4140, Maersk Medical A/S (1999). 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.

## Most influential descendants
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own
- K072291: Conmed Linvatec Bio Mini-Revo Suture Anchor (2008), 25 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K030388
Methodology: https://510kreport.com/methodology