Home › Device types › KYI
Prosthesis, Wrist, Carpal Trapezium
FDA product code KYI · Class 2 · Orthopedic
181
Registered devices
345
Adverse events
5
Recalls
26
510(k) clearances
Devices with this code
Stablyx — SKELETAL DYNAMICS L.L.C.THUMB MOD HEAD TITANIUM 12MM+4 — BIOPRO, INC.NuGrip CMC — Smith & Nephew, Inc.THUMB MOD HEAD TITANIUM 14MM — BIOPRO, INC.NuGrip CMC — Smith & Nephew, Inc.THUMB TMC MD 17.5MM — BIOPRO, INC.Ensemble CMC — Ensemble Orthopedics, Inc.Integra® PyroSphere® — Ascension Orthopedics, Inc.THUMB MOD STEM TITANIUM TPS 8.5mm — BIOPRO, INC.THUMB MOD STEM 11.5mm — BIOPRO, INC.Integra® NuGrip® — Ascension Orthopedics, Inc.Stablyx — SKELETAL DYNAMICS L.L.C.THUMB MOD STEM TITANIUM TPS 11.5mm — BIOPRO, INC.Integra® NuGrip® — Ascension Orthopedics, Inc.Stablyx — SKELETAL DYNAMICS L.L.C.Stablyx — SKELETAL DYNAMICS L.L.C.Ascension® PyroSphere — Ascension Orthopedics, Inc.THUMB MOD STEM COBALT TPS 8.5mm — BIOPRO, INC.NuGrip CMC — Smith & Nephew, Inc.Ensemble CMC — Ensemble Orthopedics, Inc.Integra® NuGrip® — Ascension Orthopedics, Inc.Ascension® NuGrip® — Ascension Orthopedics, Inc.Ascension® PyroHemiSphere — Ascension Orthopedics, Inc.PyroSphere CMC — Smith & Nephew, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-08 | Wright Medical Technology, Inc. | The firm discovered a lack of adequate documentation confirming sterility on certain products. |
| 2013-06-03 | Integra LifeSciences Corp. | As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2010-07-12 | Ascension Orthopedics, Inc | Two different product lots were found to be incorrectly labeled and placed into the incorrect box. |
| 2003-01-24 | Avanta Orthopaedics, Inc. | Wrong silicone elastomer used in construction. |
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