Oxford Ankle Fusion Nail(Afn) System
FDA 510(k) K121575 · Ortho Solutions Limited
510(k) numberK121575
Submission
- Device name
- Oxford Ankle Fusion Nail(Afn) System
- Applicant
- Ortho Solutions Limited
Prior Lake, MN, US - Received
- May 30, 2012
- Decision date
- September 14, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K141784 | Ortho Solutions Ultos Plating SystemHRS · Traditional | 07/23/2014SE |
| K120360 | Ortho Solutions Trauma Plates for OsteosysnthesisHRS · Traditional | 05/29/2012SE |
| K111678 | Ortho Solutions Extremity Fixation Implants for OsteosysnthesisHRS · Traditional | 02/07/2012SE |
| K110895 | Ortho Solutions Trauma Implants for OsteosynthesisHWC · Traditional | 12/19/2011SE |
| K102743 | Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresHWE · Traditional | 01/20/2011SE |
Questions and answers
When was Oxford Ankle Fusion Nail(Afn) System cleared by the FDA?
Oxford Ankle Fusion Nail(Afn) System (K121575) received a 510(k) decision of Substantially Equivalent on September 14, 2012, 107 days after the submission was received.
What is the product code of K121575?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.