ATTUNE Cemented Tibial Base, Fixed Bearing
FDA 510(k) K170806 · Depuy(Ireland)
510(k) numberK170806
Submission
- Device name
- ATTUNE Cemented Tibial Base, Fixed Bearing
- Applicant
- Depuy(Ireland)
Cork, IE - Received
- March 17, 2017
- Decision date
- June 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
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| K160907 | DePuy Actis DuoFix Hip ProsthesisMEH · Traditional | 07/19/2016SE |
| K160700 | ATTUNE Revision Knee SystemJWH · Traditional | 06/10/2016SE |
| K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsMBH · Traditional | 02/13/2015SE |
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Questions and answers
When was ATTUNE Cemented Tibial Base, Fixed Bearing cleared by the FDA?
ATTUNE Cemented Tibial Base, Fixed Bearing (K170806) received a 510(k) decision of Substantially Equivalent on June 15, 2017, 90 days after the submission was received.
What is the product code of K170806?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.