AlignX Ankle Fusion System
FDA 510(k) K181067 · Extremity Medical, LLC
510(k) numberK181067
Submission
- Device name
- AlignX Ankle Fusion System
- Applicant
- Extremity Medical, LLC
Parsippany, NJ, US - Received
- April 23, 2018
- Decision date
- May 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K250536 | MetaFore Small Screw SystemHWC · Traditional | 10/08/2025SE |
| K251128 | Extremity Medical External Fixation SystemKTT · Special | 05/07/2025SE |
| K241563 | Extremity Medical External Fixation SystemKTT · Traditional | 02/21/2025SE |
| K212297 | Omni Foot and Ankle Plating SystemHRS · Special | 08/20/2021SE |
| K211261 | Axis Charcot Fixation SystemHWC · Special | 05/28/2021SE |
| K201556 | Intraosseous Fixation SystemHWC · Special | 07/08/2020SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | 03/04/2020SE |
| K192592 | Axis Plating SystemHRS · Traditional | 11/21/2019SE |
| K180808 | Omni Foot Plating SystemHRS · Traditional | 05/22/2018SE |
| K172260 | Omni Foot Plating SystemHRS · Traditional | 11/06/2017SE |
Questions and answers
When was AlignX Ankle Fusion System cleared by the FDA?
AlignX Ankle Fusion System (K181067) received a 510(k) decision of Substantially Equivalent on May 23, 2018, 30 days after the submission was received.
What is the product code of K181067?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.