TalarLift STS
FDA 510(k) K170624 · Fusion Orthopedics, LLC
510(k) numberK170624
Submission
- Device name
- TalarLift STS
- Applicant
- Fusion Orthopedics, LLC
Mesa, AZ, US - Received
- March 2, 2017
- Decision date
- August 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, 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 |
| K190136 | Fusion Silastic SystemKWH · Traditional | 10/21/2019SE |
| K182342 | IntraLock Lapidus SystemHWC · Traditional | 05/21/2019SE |
| K182684 | HammerTechTM Fixation SystemHWC · Traditional | 11/23/2018SE |
| K181815 | DynaBridgeJDR · Traditional | 10/15/2018SE |
Questions and answers
When was TalarLift STS cleared by the FDA?
TalarLift STS (K170624) received a 510(k) decision of Substantially Equivalent on August 11, 2017, 162 days after the submission was received.
What is the product code of K170624?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.