Home › Device types › HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
FDA product code HSX · Class 2 · Orthopedic
8,899
Registered devices
2,520
Adverse events
104
Recalls
115
510(k) clearances
Devices with this code
GMK Uni — Medacta International SAMOTO Partial Knee System — Medacta International SAJourney II — Smith & Nephew, Inc.INSTRUMENT — Howmedica Osteonics Corp.JOURNEY — Smith & Nephew, Inc.Tahoe Uni Knee System — Shalby Advanced Technologies, Inc.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.JOURNEY — Smith & Nephew, Inc.Persona® Partial Knee System — Biomet Orthopedics, LLCLinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGZUK — Smith & Nephew, Inc.STRIDE — Smith & Nephew, Inc.ORTHOLOC® — Microport Orthopedics Inc.NexGen® — Zimmer, Inc.ACCURIS — Smith & Nephew, Inc.LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGINSTRUMENT — Howmedica Osteonics Corp.ZUK — Smith & Nephew, Inc.JOURNEY — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.MOTO Partial Knee System - Medial — Medacta International SARESTORIS ESYNTIAL — MAKO SURGICAL CORP.INSTRUMENT — Howmedica Osteonics Corp.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat |
| 2023-05-02 | Smith & Nephew, Inc. | Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The dat |
| 2023-03-27 | Smith & Nephew, Inc. | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of th |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen |
| 2023-03-21 | Linkbio Corp. | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosen |
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