# Acufex Microsurgical, Inc.

- Location (FDA's records): Mansfield, MA
- FDA decisions: 78 (1980–1996): 78 510(k) clearances
- Product codes: HRX (26), JDR (9), HWC (6), KGS (4), GCJ (3), LXH (2), GAE (2), LZC (2), HTJ (2), HSZ (2), FZX (2), HTY (2)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 41 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Smith & Nephew, Inc.: 16 (https://510kreport.com/company/smith-nephew)
- Bionx Implants, Inc.: 4 (https://510kreport.com/company/bionx-implants)
- Bioscience, Inc.: 2 (https://510kreport.com/company/bioscience)
- Future Medical Systems, Inc.: 2 (https://510kreport.com/company/future-medical-systems)
- Uromed Corp.: 2 (https://510kreport.com/company/uromed)
- American Medical Systems, Inc.: 2 (https://510kreport.com/company/american-medical-systems)
- Emerald Medical, Inc.: 1 (https://510kreport.com/company/emerald-medical)
- Linvatec Corp.: 1 (https://510kreport.com/company/linvatec)

## Its most-cited devices
- K911837: Suretac Polyglyconate Absorbable Fixation Device (1991), cited by 7
- K925573: Acufex T-Bar (1993), cited by 3
- K931519: Acufex Suretac (1994), cited by 3
- K942442: Acufex T-Fix Delivery System (1994), cited by 3
- K921481: Interference-Cannu-Flex/Silk Screws-Screw DR/G Wir (1993), cited by 3
- K961555: Acufex Tag Bioabsorbable Anchors (1996), cited by 2

## Recent decisions
- K961555: Acufex Tag Bioabsorbable Anchors (Jul 10, 1996)
- K961853: Proline Fast Pass Arthoscopic Needle Passer (Jun 21, 1996)
- K954246: Acufex Endofix Absorbable Interference Screw (Feb 15, 1996)
- K952535: Acufex Endobutton Tape (Feb 8, 1996)
- K953276: Acufex Tag Delivery System (Oct 5, 1995)
- K953459: Acufex Tag Anchor (Aug 23, 1995)
- K941740: Acufex Rotator Cuff Fixation Button (Jun 30, 1995)
- K944500: Acufex Patellar Bone Block Sizer (Jun 12, 1995)

Source page: https://510kreport.com/company/acufex-microsurgical