Depuy Synthes Femoral Neck System
FDA 510(k) K182154 · Synthes (USA) Products, LLC
510(k) numberK182154
Submission
- Device name
- Depuy Synthes Femoral Neck System
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- August 9, 2018
- Decision date
- October 16, 2018
- 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
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | 06/11/2026SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | 01/28/2022SE |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME)KTT · Special | 05/25/2021SE |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 04/08/2021SE |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemHRS · Traditional | 03/26/2021SE |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for…HSB · Traditional | 09/23/2020SE |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN · Traditional | 09/18/2020SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | 09/10/2020SE |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 09/09/2020SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
Questions and answers
When was Depuy Synthes Femoral Neck System cleared by the FDA?
Depuy Synthes Femoral Neck System (K182154) received a 510(k) decision of Substantially Equivalent on October 16, 2018, 68 days after the submission was received.
What is the product code of K182154?
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.