Tie-In Trapezium
FDA 510(k) K033529 · Wrightmedicaltechnologyinc
510(k) numberK033529
Submission
- Device name
- Tie-In Trapezium
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- November 10, 2003
- Decision date
- December 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYI – Prosthesis, Wrist, Carpal Trapezium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3770
- Specialty
- Orthopedic
- Implant
- Yes
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| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161KYI · Traditional | Ensemble Orthopedics, LLC | 12/02/2020SE |
| K180744 | Stablyx CMC Arthroplasty Implant SystemKYI · Special | Skeletal Dynamics, LLC | 04/11/2018SE |
| K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5KYI · Traditional | Skeletal Dynamics, LLC | 12/30/2011SE |
| K112278 | Ascension Nugrip CMC ImplantKYI · Traditional | Ascension Orthopedic | 11/04/2011SE |
| K092548 | Extremity Medical Trapezium ProsthesisKYI · Traditional | Extremity Medical, LLC | 12/15/2009SE |
| K061956 | Artelon STT SpacerKYI · Traditional | Artimplant AB | 06/07/2007SE |
| K061954 | Artelon CMC Spacer ArthroKYI · Special | Artimplant AB | 06/01/2007SE |
| K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40KYI · Traditional | Ascension Orthopedics, Inc. | 08/11/2006SE |
| K061089 | Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYI · Traditional | Biopro, Inc. | 06/20/2006SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | Nexa Orthopedics, Inc. | 05/10/2006SE |
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| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
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Questions and answers
When was Tie-In Trapezium cleared by the FDA?
Tie-In Trapezium (K033529) received a 510(k) decision of Substantially Equivalent on December 3, 2003, 23 days after the submission was received.
What is the product code of K033529?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.