# Parcus Medical, LLC

- Location (FDA's records): Sarasota, FL
- FDA decisions: 31 (2009–2023): 31 510(k) clearances
- Names in FDA's records: Parcus Medical, LLC (28); Parcus Medical (3)
- Product codes: MBI (23), HWC (5), MAI (3)
- 510(k) review time since 2016: median 65 days, against 83 for FDA's reviews in the same codes and years (10 of 18 faster)
- Predicates its devices cite: 68 (45 its own); citations of its devices by later devices: 59 (45 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 9 (https://510kreport.com/company/smith-nephew)
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Depuy Mitek, A Johnson & Johnson Company: 3 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Smith & Nephew Inc., Endoscopy Division: 2 (https://510kreport.com/company/smith-nephew-endoscopy-division)
- Conmed Linvatec: 2 (https://510kreport.com/company/conmed-linvatec)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Orthopaedic Biosystems, Ltd.: 1 (https://510kreport.com/company/orthopaedic-biosystems)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)

## Firms that cite its devices most
- Ortho-Design (Pty), Ltd.: 4 (https://510kreport.com/company/ortho-design)
- Auxein Medical Private Limited: 4 (https://510kreport.com/company/auxein-medical-private)
- International Life Sciences: 1 (https://510kreport.com/company/international-life-sciences)
- Medshape Solutions: 1 (https://510kreport.com/company/medshape-solutions)
- Abanza Tecnomed S.L: 1 (https://510kreport.com/company/abanza-tecnomed-s-l)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- Riverpoint Medical: 1 (https://510kreport.com/company/riverpoint-medical)
- Nvision Biomedical Technologies, Inc.: 1 (https://510kreport.com/company/nvision-biomedical-technologies)

## Its most-cited devices
- K120942: Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM Peek Suture Anc (2012), cited by 6
- K133757: GFS II Standard, GFS II Large, GFS Mimi (2014), cited by 5
- K162198: GFS Ultimate (2016), cited by 4
- K191783: Parcus Synd-EZ Ti (2019), cited by 3
- K113730: Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors (2012), cited by 3
- K111000: Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor (2011), cited by 3

## Recent decisions
- K232513: X-Twist Biocomposite Suture Anchor (Sep 18, 2023)
- K221502: Parcus Synd-EZ SS (Jul 26, 2022)
- K221135: X-Twist PEEK Suture Anchor (May 19, 2022)
- K212739: ActiFlip (Oct 6, 2021)
- K202662: Parcus Titanium Interference Screws (Feb 22, 2021)
- K202259: Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip (Oct 28, 2020)
- K201083: Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors (Jul 23, 2020)
- K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor (Jan 23, 2020)

Source page: https://510kreport.com/company/parcus-medical