# Solana Surgical, LLC

- Location (FDA's records): Memphis, TN
- FDA decisions: 8 (2009–2013): 8 510(k) clearances
- Product codes: KWD (4), HWC (2), HRS (1), JDR (1)
- Predicates its devices cite: 16 (0 its own); citations of its devices by later devices: 11 (0 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
- Vilex, LLC: 4 (https://510kreport.com/company/vilex)
- Memometal Technologies: 3 (https://510kreport.com/company/memometal-technologies)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)
- Osteomed LP: 2 (https://510kreport.com/company/osteomed)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Instratek, Inc.: 1 (https://510kreport.com/company/instratek)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)

## Firms that cite its devices most
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- MedShape, Inc.: 1 (https://510kreport.com/company/medshape)
- Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems: 1 (https://510kreport.com/company/orthodiscovery-group-dba-crossroads-extremity-systems)
- First Ray, LLC: 1 (https://510kreport.com/company/first-ray)
- Restor3D: 1 (https://510kreport.com/company/restor3d)
- Wright Medical Corp.: 1 (https://510kreport.com/company/wright-medical)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)

## Its most-cited devices
- K124045: Fuseforce Implant System (2013), cited by 6
- K090127: Metatarsal Decompression Implant, Model 100 (2009), cited by 2
- K113752: Metatarsal Decompression Implant Surgical Instrument Set (2012), cited by 1
- K132594: Crosscheck Plating System (2013), cited by 1
- K122738: Gaitway Implant System, Surgical Instrument Set (2012), cited by 1

## Recent decisions
- K132594: Crosscheck Plating System (Dec 13, 2013)
- K131187: Lesser Metatarsal Head Implant System (Oct 22, 2013)
- K124045: Fuseforce Implant System (Jul 10, 2013)
- K122738: Gaitway Implant System, Surgical Instrument Set (Nov 7, 2012)
- K120390: Solafix Twist Screw Implant System, Surgical Instrument Set (Apr 10, 2012)
- K113752: Metatarsal Decompression Implant Surgical Instrument Set (Feb 6, 2012)
- K120029: Hemi Phalangeal Implant Surgical Instrument Set (Feb 6, 2012)
- K090127: Metatarsal Decompression Implant, Model 100 (May 1, 2009)

Source page: https://510kreport.com/company/solana-surgical