Attune Revision LPS Inserts
FDA 510(k) K191779 · Depuy(Ireland)
510(k) numberK191779
Submission
- Device name
- Attune Revision LPS Inserts
- Applicant
- Depuy(Ireland)
Cork, IE - Received
- July 2, 2019
- Decision date
- October 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3510
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 12/15/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | United Orthopedic Corporation | 08/22/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/25/2025SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | Depuy Ireland UC | 11/21/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | Microport Orthopedics, Inc. | 04/01/2024SE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional | Depuy Ireland UC | 03/21/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | Microport Orthopedics, Inc. | 09/27/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | Stryker | 05/19/2023SE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/21/2023SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
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| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | 01/19/2022SE |
| K192855 | DELTA XTEND(TM) Reverse Shoulder SystemPHX · Traditional | 02/24/2020SE |
| K190344 | DePuy Corail AMT Hip ProsthesisLZO · Traditional | 11/01/2019SE |
| K192448 | Delta Xtend Revers Shoulder SystemPHX · Special | 10/04/2019SE |
| K183077 | Delta Xtend Reverse Shoulder SystemPHX · Traditional | 05/17/2019SE |
| K170806 | ATTUNE Cemented Tibial Base, Fixed BearingJWH · Traditional | 06/15/2017SE |
| 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 |
| K133834 | Depuy Global Unite Shoulder SystemKWS · Traditional | 04/03/2014SE |
Questions and answers
When was Attune Revision LPS Inserts cleared by the FDA?
Attune Revision LPS Inserts (K191779) received a 510(k) decision of Substantially Equivalent on October 8, 2019, 98 days after the submission was received.
What is the product code of K191779?
The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.