Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon
FDA 510(k) K141912 · Advanced Orthopaedic Solutions, Inc.
510(k) numberK141912
Submission
- Device name
- Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon
- Applicant
- Advanced Orthopaedic Solutions, Inc.
Torrance, CA, US - Received
- July 15, 2014
- Decision date
- October 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating SystemHRS · Traditional | 10/26/2020SE |
| K202099 | AOS Galileo Trochanteric Nail SystemHSB · Special | 08/28/2020SE |
| K191598 | AOS ES Retrograde Femoral NailHSB · Special | 07/18/2019SE |
| K182466 | AOS Calcaneal Plating SystemHRS · Traditional | 10/30/2018SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | 03/15/2016SE |
| K143204 | AOS Clavicle Intramedullary DeviceHSB · Traditional | 06/03/2015SE |
| K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous ScrewHSB · Traditional | 07/08/2014SE |
| K133081 | Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…HSB · Special | 12/31/2013SE |
| K132005 | Retrograde Femoral NailHSB · Traditional | 09/10/2013SE |
| K123569 | Antegrade Femoral NailHSB · Traditional | 05/24/2013SE |
Questions and answers
When was Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon cleared by the FDA?
Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (K141912) received a 510(k) decision of Substantially Equivalent on October 29, 2014, 106 days after the submission was received.
What is the product code of K141912?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.