Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head
FDA 510(k) K992065 · DePuy Orthopaedics, Inc.
510(k) numberK992065
Submission
- Device name
- Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- June 18, 1999
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | 09/04/2026SE |
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | 05/22/2026SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K193398 | Summit DuoFix HA CoatingMEH · Special | 02/04/2020SE |
Questions and answers
When was Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head cleared by the FDA?
Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head (K992065) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 24 days after the submission was received.
What is the product code of K992065?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.