Promos Shoulder
FDA 510(k) K032126 · Plus Orthopedics
510(k) numberK032126
Submission
- Device name
- Promos Shoulder
- Applicant
- Plus Orthopedics
Round Rock, TX, US - Received
- July 10, 2003
- Decision date
- January 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3690
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233260 | Univers Revers CA Head and AdapterHSD · Traditional | Arthrex, Inc. | 02/12/2024SE |
| K221232 | Univers Revers Humeral Cup ImplantHSD · Special | Arthrex, Inc. | 05/19/2022SE |
| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | Implantcast GmbH | 11/12/2020SE |
| K193122 | Biocore9 Humeral Resurfacing SystemHSD · Traditional | Biocore9, LLC | 05/15/2020SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | Arthrosurface, Inc. | 04/18/2018SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | Arthrex, Inc. | 11/21/2016SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | Zimmer GmbH | 11/01/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | Arthrex, Inc. | 04/19/2016SE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special | Arthrosurface, Inc. | 12/19/2014SE |
| K131298 | Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional | Exactech, Inc. | 11/26/2013SE |
More from Exactech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070928 | Ceramic Ball Heads, 28, 32 and 36 MMLZO · Traditional | 08/01/2007SE |
| K070731 | Pigalileo Total Hip Replacement (THR) SystemHAW · Traditional | 07/31/2007SE |
| K070278 | Polarcup Dual Mobility SystemLPH · Traditional | 04/16/2007SE |
| K063578 | Promos Modular Shoulder SystemHSD · Traditional | 03/02/2007SE |
| K061362 | Pigalileo Total Knee Replacement (TKR) SystemHAW · Traditional | 10/06/2006SE |
| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
| K032215 | Vks/Tc-Plus Revision KneeJWH · Special | 08/08/2003SE |
| K032052 | Uc-Plus Solution Unicondylar KneeHRY · Special | 07/25/2003SE |
Questions and answers
When was Promos Shoulder cleared by the FDA?
Promos Shoulder (K032126) received a 510(k) decision of Substantially Equivalent on January 8, 2004, 182 days after the submission was received.
What is the product code of K032126?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.