Conventus PHS System
FDA 510(k) K141737 · Conventus Orthopaedics, Inc.
510(k) numberK141737
Submission
- Device name
- Conventus PHS System
- Applicant
- Conventus Orthopaedics, Inc.
Maple Grove, MN, US - Received
- June 27, 2014
- Decision date
- April 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDS – Nail, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | Smith & Nephew, Inc. | 06/12/2025SE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 09/20/2024SE |
| K241804 | TRIGEN INTERTAN 10S Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 08/22/2024SE |
| K233150 | NET BRAND Osteosynthesis Nailing SystemJDS · Traditional | Narang Medical , Ltd. | 02/20/2024SE |
| K230761 | TRIGEN META-NAIL Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 06/14/2023SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | Synthes (USA) Products, LLC | 09/03/2020SE |
| K192003 | Auxein Nailing SystemJDS · Traditional | Auxein Medical Private Limited | 06/10/2020SE |
| K193533 | WIN Flexible Nail SystemJDS · Traditional | Biomet, Inc. | 02/20/2020SE |
| K123948 | China Nails and AccessoriesJDS · Traditional | Smith & Nephew, Inc. | 03/14/2013SE |
| K111667 | Synthes Suprapatellar Insertion InstrumentsJDS · Special | Synthes (Usa) | 12/05/2011SE |
More from Synthes (Usa)
| 510(k) | Device | Decision |
|---|---|---|
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail SystemHSB · Traditional | 01/22/2021SE |
| K161048 | Conventus Orthopaedics Ulna Fixation SystemHRS · Traditional | 07/26/2016SE |
| K151379 | Conventus PRS SystemHRS · Traditional | 08/13/2015SE |
| K131552 | Conventus DRSHRS · Traditional | 02/12/2014SE |
| K102689 | Conventus Orthopaedics Fracture Fixation SystemHRS · Traditional | 01/17/2013SE |
Questions and answers
When was Conventus PHS System cleared by the FDA?
Conventus PHS System (K141737) received a 510(k) decision of Substantially Equivalent on April 8, 2015, 285 days after the submission was received.
What is the product code of K141737?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.