OVOMotion Shoulder Arthroplasty System
FDA 510(k) K173964 · Arthrosurface, Inc.
510(k) numberK173964
Submission
- Device name
- OVOMotion Shoulder Arthroplasty System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- December 29, 2017
- Decision date
- April 18, 2018
- 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 |
| 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 |
| K130759 | Humelock II Cementless Shoulder SystemHSD · Traditional | Fx Solutions | 11/09/2013SE |
More from Fx Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty SystemPHX · Traditional | 06/24/2021SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | 10/15/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | 08/14/2019SE |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR · Special | 06/14/2018SE |
| K172383 | Arthrosurface Bone ScrewsHWC · Traditional | 12/22/2017SE |
| K170440 | KISSloc Suture SystemHTN · Traditional | 05/03/2017SE |
| K170350 | ToeMATE® Hammertoe Correction SystemHWC · Special | 03/03/2017SE |
| K162391 | AlignMATE Lapidus Arthrodesis SystemHRS · Special | 02/21/2017SE |
| K161539 | Arthrosurface Bone ScrewsHWC · Special | 06/30/2016SE |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special | 04/11/2016SE |
Questions and answers
When was OVOMotion Shoulder Arthroplasty System cleared by the FDA?
OVOMotion Shoulder Arthroplasty System (K173964) received a 510(k) decision of Substantially Equivalent on April 18, 2018, 110 days after the submission was received.
What is the product code of K173964?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.