Novation
Novation 3 Degree Tapered Reamer, Size 09, Zimmer Hudson Adapter
9manufacturers in China registered for this device type
48catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (2). 5 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K042842 |
| Record published | 2022-08-18 |
| Record revised | 2018-07-06 (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 | Angle 3 to 300 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 161-09-09 | SZ 09 | In distribution |
| 161-01-02 | SIZE 12-15 | In distribution |
| 161-07-06 | SIZE 18 | In distribution |
| 160-23-14 | Size 14 | In distribution |
| 160-32-12 | Size 12 | In distribution |
| 181-16-00 | In distribution | |
| 161-07-16 | SIZE 18 | In distribution |
| 161-09-17 | Angle 3 ° | In distribution |
| 161-05-03 | SIZE 3 | In distribution |
| 160-01-20 | Size 20 | In distribution |
| 160-32-18 | Size 18 | In distribution |
| 161-02-19 | SIZE 19 | In distribution |
| 168-50-11 | Size 11 | In distribution |
| 161-06-00 | In distribution | |
| 160-23-18 | Size 18 | In distribution |
| 160-33-14 | Size 14 | In distribution |
| 161-08-10 | Angle 3 ° | In distribution |
| 160-33-18 | Size 18 | In distribution |
| 160-32-16 | Size 16 | In distribution |
| 160-32-14 | Size 14 | In distribution |
| 161-08-17 | Angle 3 ° | In distribution |
| 160-33-16 | Size 16 | In distribution |
| 161-02-17 | SIZE 17 | In distribution |
| 160-23-12 | Size 12 | In distribution |
| 161-03-00 | Angle 300 ° | In distribution |
| SPI-011287 | In distribution | |
| 161-07-12 | SIZE 14 | In distribution |
| 161-05-04 | SIZE4 | In distribution |
| 168-50-15 | Size 15 | In distribution |
| 161-04-00 | Angle 300 ° | In distribution |
| 168-00-13 | Size 13 | In distribution |
| 168-00-09 | Size 9 | In distribution |
| 161-07-14 | SIZE 16 | In distribution |
| 160-22-16 | Size 16 | In distribution |
| 160-33-12 | Size 12 | In distribution |
| 168-00-15 | Size 15 | In distribution |
| 160-22-18 | Size 18 | In distribution |
| 168-00-11 | Size 11 | In distribution |
| 161-08-13 | Angle 3 ° | In distribution |
| 161-07-02 | SIZE 14 | In distribution |
| 161-09-03 | SIZE 13/14 | In distribution |
| 161-06-00 | In distribution | |
| 161-02-16 | SIZE 16 | In distribution |
| 168-50-13 | Size 13 | In distribution |
| 168-00-17 | Size 17 | In distribution |
| 160-22-12 | Size 12 | In distribution |
| 160-22-14 | Size 14 | In distribution |
| 160-23-16 | Size 16 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
| Aesculap | Aesculap AG | 38 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090764 | 2009-04-21 |
| K002141 | 2000-08-16 |
Recalls Naming This Product
33 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 | Closed |
|---|---|---|---|---|---|---|---|
| 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. | ||
| 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 | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 1017 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 132 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 11143 DEVICES | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 2319 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 17929 units | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 7946 devices | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 29 devices | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 30 devices | |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 79 units | 2019-08-05 |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 12 devices | 2019-08-05 |
| Exactech, Inc. | 510(k) number | 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 8 units | 2019-07-26 |
| Exactech, Inc. | 510(k) number | 2016-05-26 | Class II | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | 14 | 2019-07-26 |
| Exactech, Inc. | 510(k) number | 2007-11-01 | Not classified | Process control | Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 – 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm | 10 | 2012-05-06 |
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.