Fusion Silastic System
FDA 510(k) K190136 · Fusion Orthopedics, LLC
510(k) numberK190136
Submission
- Device name
- Fusion Silastic System
- Applicant
- Fusion Orthopedics, LLC
Mesa, AZ, US - Received
- January 29, 2019
- Decision date
- October 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWH – Prosthesis, Toe, Constrained, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3720
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191966 | NewPrim SystemKWH · Traditional | Brm Extremities | 02/13/2020SE |
| K173491 | RTS Lesser MTP Implant SystemKWH · Traditional | In2bones USA, LLC | 02/23/2018SE |
| K153609 | RTS Flexible 1 MPJ Implant w/GrommetsKWH · Traditional | In2bones USA, LLC | 09/08/2016SE |
| K102601 | Orthoflex RodKWH · Traditional | Ortho-Pro, LLC | 01/14/2011SE |
| K023531 | Lesser Metatarsal Phalangeal Joint ImplantKWH · Traditional | Nexa Orthopedics, Inc. | 01/17/2003SE |
| K022887 | Interphalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/26/2002SE |
| K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemKWH · Traditional | Osteomed Corp. | 11/25/2002SE |
| K023562 | Modification to Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 11/13/2002SE |
| K023086 | Classic Great Toe ImplantKWH · Special | Nexa Orthopedics, Inc. | 10/04/2002SE |
| K994326 | Ascent Knee SystemKWH · Special | Biomet Manufacturing, Inc. | 01/07/2000SE |
More from Biomet Manufacturing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242091 | Bolo Button SystemHTN · Traditional | 12/23/2024SE |
| K211843 | PolyLock Plating SystemHRS · Traditional | 03/04/2022SE |
| K210159 | IntraLock SystemHWC · Traditional | 07/23/2021SE |
| K193377 | TopLock Anchor SystemMBI · Traditional | 11/25/2020SE |
| K202959 | PolyLock Plating SystemHRS · Traditional | 11/24/2020SE |
| K192323 | PolyLock Small Bone Plating SystemHRS · Traditional | 11/18/2019SE |
| K182342 | IntraLock Lapidus SystemHWC · Traditional | 05/21/2019SE |
| K182684 | HammerTechTM Fixation SystemHWC · Traditional | 11/23/2018SE |
| K181815 | DynaBridgeJDR · Traditional | 10/15/2018SE |
| K170624 | TalarLift STSHWC · Traditional | 08/11/2017SE |
Questions and answers
When was Fusion Silastic System cleared by the FDA?
Fusion Silastic System (K190136) received a 510(k) decision of Substantially Equivalent on October 21, 2019, 265 days after the submission was received.
What is the product code of K190136?
The FDA product code is KWH – Prosthesis, Toe, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3720.