# Ortho Solutions Limited

- Location (FDA's records): Prior Lake, MN
- FDA decisions: 6 (2011–2014): 6 510(k) clearances
- Product codes: HRS (3), HWE (1), HWC (1), HSB (1)
- Predicates its devices cite: 58 (1 its own); citations of its devices by later devices: 18 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 8 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Aap Implantate AG: 4 (https://510kreport.com/company/aap-implantate)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Depuy, Inc.: 2 (https://510kreport.com/company/depuy)
- Biopro, Inc.: 2 (https://510kreport.com/company/biopro)

## Firms that cite its devices most
- Ortho Solutions UK, Ltd.: 7 (https://510kreport.com/company/ortho-solutions-uk)
- Normed Medizin-Technik GmbH: 2 (https://510kreport.com/company/normed-medizin-technik)
- Zimmer, Inc.: 2 (https://510kreport.com/company/zimmer)
- Biopro, Inc.: 2 (https://510kreport.com/company/biopro)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- I.T.S. GmbH: 1 (https://510kreport.com/company/its)
- Infix Medical, LLC: 1 (https://510kreport.com/company/infix-medical)
- Additive Orthopaedics, LLC: 1 (https://510kreport.com/company/additive-orthopaedics)

## Its most-cited devices
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), cited by 8
- K141784: Ortho Solutions Ultos Plating System (2014), cited by 4
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), cited by 3
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (2012), cited by 2
- K121575: Oxford Ankle Fusion Nail (Afn) System (2012), cited by 1

## Recent decisions
- K141784: Ortho Solutions Ultos Plating System (Jul 23, 2014)
- K121575: Oxford Ankle Fusion Nail (Afn) System (Sep 14, 2012)
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis (May 29, 2012)
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (Feb 7, 2012)
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (Dec 19, 2011)
- K102743: Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires (Jan 20, 2011)

Source page: https://510kreport.com/company/ortho-solutions