# Concept, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 84 (1976–1992): 83 510(k) clearances and 1 original PMA approval
- Product codes: GEI (10), HRX (10), HWC (4), HNL (3), HKP (2), KGS (2), KNT (2), ETD (2), GFA (1), KNS (1), HMX (1), HWE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Biomet Sports Medicine: 1 (https://510kreport.com/company/biomet-sports-medicine)
- Medicinelodge, Inc.: 1 (https://510kreport.com/company/medicinelodge)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Arthrotek/Biomet, Inc.: 1 (https://510kreport.com/company/arthrotek-biomet)
- Smith & Nephew Endoscopy, Inc.: 1 (https://510kreport.com/company/smith-nephew-endoscopy)

## Its most-cited devices
- K871037: Cancellous Fixation Screw & Washer for Use W/Screw (1987), cited by 3
- K894929: Staple Fixation System (1989), cited by 1
- K792365: Bipolar Forceps (1979), cited by 1

## Recent decisions
- K912640: Concept Endosteal Fixation Device (May 1, 1992)
- K912957: Concept Micromill (Oct 4, 1991)
- K896648: Concept Unicompartmental Knee System (Jun 5, 1990)
- K894929: Staple Fixation System (Aug 30, 1989)
- K892376: Intravision (TM) Arthroscope System (Add'l Appli.) (Aug 1, 1989)
- K891109: Panda (R) Needle Catheter Jejunostomy Tube (May 8, 1989)
- K881954: Concept Power System (Nov 9, 1988)
- K884255: Concept CCT-5200, Thermal Therapy System (Nov 8, 1988)

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