ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
FDA 510(k) K233980 · Depuy Ireland UC
510(k) numberK233980
Submission
- Device name
- ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- Applicant
- Depuy Ireland UC
Ringaskiddy, IE - Received
- December 18, 2023
- Decision date
- March 21, 2024
- 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 |
| 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 |
| K223528 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/20/2023SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | 06/25/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | 06/25/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | 05/15/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | 03/11/2026SE |
| K253551 | VELYS Hip NavigationQIH · Traditional | 03/06/2026SE |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral AdaptorsJWH · Traditional | 11/19/2025SE |
| K251292 | RECLAIM Monobloc Revision Femoral StemLZO · Special | 05/23/2025SE |
| K243977 | EMPHASYS Acetabular SystemLPH · Special | 01/22/2025SE |
| K243248 | Inhance IntactPKC · Traditional | 12/23/2024SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | 11/21/2024SE |
Questions and answers
When was ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System cleared by the FDA?
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980) received a 510(k) decision of Substantially Equivalent on March 21, 2024, 94 days after the submission was received.
What is the product code of K233980?
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.