Novation
LINER DRIVER HEAD, NOVATION, 40mm
5manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), 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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | OQI |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K173583 |
| Record published | 2018-03-15 |
| Record revised | 2025-08-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 40 mm |
| Distribution end date | 2021-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 142-28-61 | Anterior Lipped | In distribution |
| 142-36-65 | Anterior Lipped | In distribution |
| 148-32-51 | 10 Deg Face Changing | In distribution |
| 142-28-50 | 28mm ID | In distribution |
| 148-40-54 | 10 Deg Face Changing | In distribution |
| 140-36-54 | 36mm ID | In distribution |
| 148-36-53 | 10 Deg Face Changing | In distribution |
| 142-28-52 | 28mm ID | In distribution |
| 140-40-55 | 40mm ID | In distribution |
| 148-36-55 | 10 Deg Face Changing | In distribution |
| 146-36-53 | +5mm Lateralized | In distribution |
| 140-40-53 | 40mm ID | In distribution |
| 146-40-54 | +5mm Lateralized | In distribution |
| 146-36-55 | +5mm Lateralized | In distribution |
| 141-01-40 | Spherical Diameter | In distribution |
| 140-28-50 | 28mm ID | In distribution |
| 142-40-54 | Lipped | In distribution |
| 140-36-52 | 36mm ID | In distribution |
| 142-32-63 | Anterior Lipped | In distribution |
| 142-40-64 | Anterior Lipped | In distribution |
| 142-32-51 | Lipped | In distribution |
| 142-36-63 | Anterior Lipped | In distribution |
| 141-01-40 | Outer Diameter 40 mm | In distribution |
| 142-36-55 | Lipped | In distribution |
| 140-32-52 | 32mm ID | In distribution |
| 142-32-53 | Lipped | In distribution |
| 142-32-55 | Lipped | In distribution |
| 146-32-51 | +5mm Lateralized | In distribution |
| 142-36-53 | Lipped | In distribution |
| 142-32-61 | Anterior Lipped | In distribution |
| 142-22-68 | Anterior Lipped | In distribution |
| 146-22-70 | +5mm Lateralized | Withdrawn |
| 140-32-54 | 32mm ID | Withdrawn |
| 146-32-53 | +5mm Lateralized | Withdrawn |
| 140-28-52 | 28mm ID | Withdrawn |
| 142-32-65 | Anterior Lipped | Withdrawn |
| 146-32-55 | +5mm Lateralized | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 260 |
| Epore® XO | implantcast GmbH | 64 |
| G7® | Biomet Orthopedics | 50 |
| InSitu Hip System | Nextstep Arthropedix | 50 |
| G7 Acetabular Liner | Biomet Orthopedics | 47 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | implantcast GmbH | 40 |
| Trinity Acetabular Hip System with ECiMa Liners | Corin Limited | 28 |
| Procotyl® Prime | Microport Orthopedics Inc. | 25 |
| AcuMatch | Exactech, Inc. | 23 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 23 |
| G7® Longevity® | Zimmer, Inc. | 23 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 22 |
Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173583 | 2018-03-12 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 42 |
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 87 |
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 1446 |
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | |
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
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.