# Acu Med, Inc.

- Location (FDA's records): Beaverton, OR
- FDA decisions: 48 (1990–2002): 48 510(k) clearances
- Names in FDA's records: Acu Med, Inc. (43); Acu-Med, Inc. (5)
- Product codes: HWC (9), HSB (9), HRS (4), HTN (4), JEC (3), JDQ (3), HRX (2), LZJ (2), HTY (2), MBI (2), LRN (1), JDS (1)
- Predicates its devices cite: 14 (2 its own); citations of its devices by later devices: 67 (2 its own)
- Recalls linked to its devices: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Howmedica Corp.: 2 (https://510kreport.com/company/howmedica)
- Mitek Surgical Products, Inc.: 1 (https://510kreport.com/company/mitek-surgical-products)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Linvatec Corp.: 1 (https://510kreport.com/company/linvatec)
- Turnkey Intergration USA, Inc.: 1 (https://510kreport.com/company/turnkey-intergration-usa)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Intermedics Orthopedics: 1 (https://510kreport.com/company/intermedics-orthopedics)

## Firms that cite its devices most
- Acumed, LLC: 13 (https://510kreport.com/company/acumed)
- I.T.S. Implantat-Technologie-Systeme GmbH: 4 (https://510kreport.com/company/its-implantat-technologie-systeme)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- I.T.S. GmbH: 3 (https://510kreport.com/company/its)
- Acute Innovations, LLC: 2 (https://510kreport.com/company/acute-innovations)
- Newclip Technics: 2 (https://510kreport.com/company/newclip-technics)
- New Deal, S.A.: 2 (https://510kreport.com/company/new-deal)
- Reiley Orthopaedics, Inc.: 2 (https://510kreport.com/company/reiley-orthopaedics)

## Its most-cited devices
- K012655: Congruent Bone Plate System (2001), cited by 28
- K944330: Acutrak Plus Fixation System (1995), cited by 8
- K951740: Intramedulary Fixation Rod (1995), cited by 5
- K930834: Acutract (1993), cited by 5
- K992525: Acumed Modular Shoulder System (2000), cited by 4
- K021321: Wrist Fusion Plate (2002), cited by 3

## Recent decisions
- K021321: Wrist Fusion Plate (Jul 17, 2002)
- K013616: Polarus Cap Screw (Dec 19, 2001)
- K012655: Congruent Bone Plate System (Nov 7, 2001)
- K992525: Acumed Modular Shoulder System (Feb 4, 2000)
- K993657: Acumed Suture Anchor (Jan 13, 2000)
- K980103: Acumed Suture Anchor (Mar 16, 1998)
- K965028: Acumed Suture Washer (Mar 17, 1997)
- K965029: Stableloc II External Fixator (Feb 19, 1997)

Source page: https://510kreport.com/company/acu-med