Home › Device types › HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
FDA product code HSX · Class 2 · Orthopedic
8,923
Registered devices
2,561
Adverse events
104
Recalls
115
510(k) clearances
Devices with this code
ACCURIS — Smith & Nephew, Inc.BKS® Uni — Ortho Development CorporationNA — Zimmer, Inc.PB Uni tibial trial insert — implantcast GmbHPB Uni tibial trial insert — implantcast GmbHTriathlon — Howmedica Osteonics Corp.Triathlon — Howmedica Osteonics Corp.INSTRUMENT — Howmedica Osteonics Corp.Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KGINSTRUMENT — Howmedica Osteonics Corp.ENGAGE — Smith & Nephew, Inc.Engage Partial Knee System — Engage UNI LLCUnicondylar Knee System — GLOBUS MEDICAL, INC.LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KGORTHOLOC® — Microport Orthopedics Inc.N/A — Ortho Development CorporationRESTORIS — MAKO SURGICAL CORP.JOURNEY — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.NA — Zimmer, Inc.INSTRUMENT — Howmedica Osteonics Corp.BKS® Uni — Ortho Development CorporationEngage Partial Knee System — Engage UNI LLCJOURNEY — Smith & Nephew, Inc.
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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