OVOMotion™
Humeral Component, 48mm x 44mm, OVOMotion
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Arthrosurface, Inc., United States |
|---|---|
| FDA product code | HSD |
| Device type | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K173964 |
| Record published | 2018-11-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8HM2-4844-A | In distribution | |
| 8HM2-5248-A | In distribution | |
| 8HM2-5046-A | In distribution | |
| 8HM2-5450-A | In distribution | |
| 8HM2-5652-A | In distribution | |
| 8HM2-4642-A | In distribution | |
| 8HM2-5854-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 345 |
| SMR Shoulder | Limacorporate | 182 |
| FX V135 | Fx Shoulder Solutions SAS | 127 |
| Acumed | Acumed LLC | 112 |
| Promos | Smith & Nephew, Inc. | 104 |
| Trabecular Metal® | Zimmer, Inc. | 90 |
| Bigliani/Flatow® | Zimmer, Inc. | 86 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 85 |
| Arthrex® | Arthrex, Inc. | 75 |
| SMR System | Limacorporate | 72 |
| DJO Surgical | Encore Medical, L.P. | 70 |
| Humeris Shoulder | Fx Solutions | 69 |
Showing 12 of 241. All products under Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173964 | 2018-04-18 |
| K142942 | 2014-12-19 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. 5 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-11-24 | Class II | No Marketing Application | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | 136 | 2015-03-27 |
| 2014-11-24 | Class II | No Marketing Application | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | 143 | 2015-03-27 |
| 2014-11-24 | Class II | No Marketing Application | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | 187 | 2015-03-27 |
| 2014-11-24 | Class II | No Marketing Application | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | 138 | 2015-03-27 |
| 2014-11-24 | Class II | No Marketing Application | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. | 182 units | 2015-03-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.