Humelock II Cementless Shoulder System
FDA 510(k) K130759 · Fx Solutions
510(k) numberK130759
Submission
- Device name
- Humelock II Cementless Shoulder System
- Applicant
- Fx Solutions
Viriat, FR - Received
- March 20, 2013
- Decision date
- November 9, 2013
- 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 |
|---|---|---|
| K163669 | Humeris ShoulderPHX · Traditional | 05/17/2017SE |
| K162455 | Humelock Reversed ShoulderPHX · Traditional | 01/17/2017SE |
| K150488 | Humelock II Reversible Shoulder SystemPHX · Traditional | 11/13/2015SE |
| K143721 | PRCT2HRS · Traditional | 08/27/2015SE |
| K140071 | Humelock II Cemented Shoulder SystemKWT · Traditional | 07/28/2014SE |
| K123814 | Humelock II Cemented Shoulder SystemKWT · Traditional | 08/13/2013SE |
| K111097 | Humelock Cemented Shoulder ProsthesisHSD · Traditional | 11/09/2011SE |
Questions and answers
When was Humelock II Cementless Shoulder System cleared by the FDA?
Humelock II Cementless Shoulder System (K130759) received a 510(k) decision of Substantially Equivalent on November 9, 2013, 234 days after the submission was received.
What is the product code of K130759?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.