# K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H

- Pathway: 510(k) (Special)
- Applicant: Linvatec Biomaterials, Ltd.
- Decided: Nov 19, 2004 after 22 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911837 (1991). 47 ancestors in all.
76 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.
- K030388: Impact Suture Anchor. Model 433510, Bionx Implants, Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM (2013), 17 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042966
Methodology: https://510kreport.com/methodology