Global Total Shoulder
FDA 510(k) K914695 · Depuy, Inc.
510(k) numberK914695
Submission
- Device name
- Global Total Shoulder
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- October 18, 1991
- Decision date
- January 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3650
- Specialty
- Orthopedic
- Implant
- Yes
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| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
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| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
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| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Global Total Shoulder cleared by the FDA?
Global Total Shoulder (K914695) received a 510(k) decision of Substantially Equivalent on January 16, 1992, 90 days after the submission was received.
What is the product code of K914695?
The FDA product code is KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3650.