Biocore9 Humeral Resurfacing System
FDA 510(k) clearance K193122 · decided 2020-05-15
Clearance details
- K-number
- K193122
- Device name
- Biocore9 Humeral Resurfacing System
- Applicant
- Biocore9, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-11-12
- Decision date
- 2020-05-15
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- HSD
- Device class
- 2
- Regulation number
- 888.3690
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Whippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Univers Revers CA Head and Adapter (K233260) | Arthrex, Inc. | 2024-02-12 |
| Univers Revers Humeral Cup Implant (K221232) | Arthrex, Inc. | 2022-05-19 |
| AGILON® XO Shoulder Replacement System (K191433) | Implantcast GmbH | 2020-11-12 |
| OVOMotion Shoulder Arthroplasty System (K173964) | Arthrosurface, Inc. | 2018-04-18 |
| Arthrex Univers Revers Shoulder Prosthesis System (K161782) | Arthrex, Inc. | 2016-11-21 |
| Anatomical Shoulder Domelock Dome centric (K161620) | Zimmer GmbH | 2016-11-01 |
| Arthrex Univers Revers CA Heads and Adapters (K151527) | Arthrex, Inc. | 2016-04-19 |
| HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (K142942) | Arthrosurface, Inc. | 2014-12-19 |
| EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298) | Exactech, Inc. | 2013-11-26 |
| HUMELOCK II CEMENTLESS SHOULDER SYSTEM (K130759) | Fx Solutions | 2013-11-09 |
| ARTHREX UNIVERS II CA HEADS (K130675) | Arthrex, Inc. | 2013-10-30 |
| SEVIIN SURFACE REPLACEMENT SHOULDER (K130635) | Ingen Orthopedics, LLC | 2013-08-26 |
Recalls involving this device
No recalls on record reference this clearance.