# K053561: Bio-Mini Revo Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Feb 23, 2006 after 64 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: 7 generations back to K911837 (1991). 54 ancestors in all.
75 later devices descend from it; 7 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H, Linvatec Biomaterials, Ltd. (2004) Summary page 2.
- K030388: Impact Suture Anchor. Model 433510, Bionx Implants, Ltd. (2003) Summary page 2.
- K020056: Duet Suture Anchor, Bionx Implants, Ltd. (2002) Summary page 2.
- K050497: Bioscrew Xtralok, 8X35MM & 8X40MM Violet, Linvatec Corp. (2005) Summary page 2.
- K020377: Pre-Loaded Biostinger Hornet, Linvatec Corp. (2002) Summary page 2.
- K991715: Biostinger-V Bioabsorbable Meniscal Repair Device, Linvatec Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K090075: Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258 (2009), 13 descendants of its own

## Indications for use
The Bio-Mini Revo Suture Anchor is intended to reattach soft tissue to bone in orthopedic 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.

Source page: https://510kreport.com/device/K053561
Methodology: https://510kreport.com/methodology