HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class II
FDA product code HSD covers "Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented", a Class II medical device regulated under 21 CFR 888.3690. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HSD
- Device Class
- Class II
- Regulation Number
- 888.3690
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233260 | arthrex | Univers Revers CA Head and Adapter | February 12, 2024 |
| K221232 | arthrex | Univers Revers Humeral Cup Implant | May 19, 2022 |
| K191433 | implantcast | AGILON® XO Shoulder Replacement System | November 12, 2020 |
| K193122 | biocore9 | Biocore9 Humeral Resurfacing System | May 15, 2020 |
| K173964 | arthrosurface | OVOMotion Shoulder Arthroplasty System | April 18, 2018 |
| K161782 | arthrex | Arthrex Univers Revers Shoulder Prosthesis System | November 21, 2016 |
| K161620 | zimmer | Anatomical Shoulder Domelock Dome centric | November 1, 2016 |
| K151527 | arthrex | Arthrex Univers Revers CA Heads and Adapters | April 19, 2016 |
| K142942 | arthrosurface | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System | December 19, 2014 |
| K131298 | exactech | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | November 26, 2013 |
| K130759 | fx solutions | HUMELOCK II CEMENTLESS SHOULDER SYSTEM | November 9, 2013 |
| K130675 | arthrex | ARTHREX UNIVERS II CA HEADS | October 30, 2013 |
| K130635 | ingen orthopedics | SEVIIN SURFACE REPLACEMENT SHOULDER | August 26, 2013 |
| K121714 | smith and nephew | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | September 7, 2012 |
| K112900 | lima corporate | SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS | June 1, 2012 |
| K112983 | tecres | SPACER-S | December 12, 2011 |
| K111097 | fx solutions | HUMELOCK CEMENTED SHOULDER PROSTHESIS | November 9, 2011 |
| K082715 | depuy orthopaedics | DEPUY GLOBAL AP CTA HUMERAL HEAD | December 18, 2008 |
| K080990 | depuy orthopaedics | DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER | August 8, 2008 |
| K073331 | dvo extremity solutions | DVO EXTENDED ARTICULATION HUMERAL HEADS | February 19, 2008 |