# Acumed, LLC

- Location (FDA's records): Hillsboro, OR
- FDA decisions: 38 (2003–2025): 38 510(k) clearances
- Product codes: HRS (20), HWC (5), HTN (4), HSB (3), MBI (2), KWI (2), JDW (1), LXT (1)
- 510(k) review time since 2016: median 94 days, against 90 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 104 (18 its own); citations of its devices by later devices: 91 (18 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 24 (https://510kreport.com/company/synthes-usa)
- Acu Med, Inc.: 13 (https://510kreport.com/company/acu-med)
- Osteomed LP: 6 (https://510kreport.com/company/osteomed)
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)
- Howmedica Osteonics Corp.: 4 (https://510kreport.com/company/howmedica-osteonics)
- Medartis AG: 4 (https://510kreport.com/company/medartis)
- Dvo Extremity Solutions, LLC: 2 (https://510kreport.com/company/dvo-extremity-solutions)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)

## Firms that cite its devices most
- I.T.S. GmbH: 4 (https://510kreport.com/company/its)
- Newclip Technics: 4 (https://510kreport.com/company/newclip-technics)
- I.T.S. Implantat-Technologie-Systeme GmbH: 3 (https://510kreport.com/company/its-implantat-technologie-systeme)
- Intrafuse, LLC: 3 (https://510kreport.com/company/intrafuse)
- Medartis AG: 3 (https://510kreport.com/company/medartis)
- Mylad Orthopedic Solutions, LLC: 2 (https://510kreport.com/company/mylad-orthopedic-solutions)
- Advanced Orthopaedic Solutions, Inc. (Aos): 2 (https://510kreport.com/company/advanced-orthopaedic-solutions-aos)
- Subchondral Solutions, Inc.: 2 (https://510kreport.com/company/subchondral-solutions)

## Its most-cited devices
- K102998: Congruent Bone Plate  System (2011), cited by 10
- K031438: Acumed Small Bone Locking Rod System II (2003), cited by 9
- K071715: Acumed Congruent Bone Plate System (2007), cited by 8
- K123890: Acumed Cannulated Screw System (2013), cited by 6
- K033639: Acumed Lower Extremity Congruent Plate System (2004), cited by 6
- K143276: Acumed Small Bone IM Nail System (2015), cited by 5

## Recent decisions
- K252356: The Acumed Wrist Fixation System - 2.4mm Screws (Aug 21, 2025)
- K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (Jul 14, 2025)
- K251296: The Acumed Wrist Fixation System (Jun 18, 2025)
- K243624: Acu-Sinch Knotless Mini (Jan 23, 2025)
- K233311: Acumed Wrist Plating System (Apr 22, 2024)
- K230744: Acumed Acutrak 3 Headless Compression Screw System (Jun 9, 2023)
- K221333: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional (Dec 29, 2022)
- K212990: Acumed Ankle Syndesmosis Repair System (Jan 7, 2022)

Source page: https://510kreport.com/company/acumed