# Gold Standard Orthopaedics, LLC

- Location (FDA's records): Louisville, KY
- FDA decisions: 4 (2007–2013): 4 510(k) clearances
- Product codes: KWP (2), HWC (1), MNH (1)
- Predicates its devices cite: 15 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Interpore Cross Intl.: 2 (https://510kreport.com/company/interpore-cross-intl)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Plus Orthopedics: 1 (https://510kreport.com/company/plus-orthopedics)
- Biodynamic Technologies, Inc.: 1 (https://510kreport.com/company/biodynamic-technologies)
- Internal Fixation Systems, Inc.: 1 (https://510kreport.com/company/internal-fixation-systems)
- Osteomed LP: 1 (https://510kreport.com/company/osteomed)

## Firms that cite its devices most
- Internal Fixation Systems, Inc.: 1 (https://510kreport.com/company/internal-fixation-systems)

## Its most-cited devices
- K070966: Gso GS1 Spinal System (2007), cited by 2
- K063589: Gso Bone Fixation Fasteners (2007), cited by 1

## Recent decisions
- K123487: Gso GS1 Cannulated Screw System (Mar 11, 2013)
- K091359: Gso PCT Spinal System (Sep 2, 2009)
- K070966: Gso GS1 Spinal System (Jul 20, 2007)
- K063589: Gso Bone Fixation Fasteners (Jan 31, 2007)

Source page: https://510kreport.com/company/gold-standard-orthopaedics