Novation
Tapered Reamer, Zimmer Hudson, Novation 3°, Size 9/10
15manufacturers in China registered for this device type
105catalogue numbers in this listing
21510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083392 |
| Record published | 2015-10-30 |
| Record revised | 2025-09-04 (version 5) |
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 48 to 68 mm; angle 3 ° |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 160-71-15 | Size 15 | In distribution |
| 160-50-13 | Standard Offset | In distribution |
| 160-51-17 | Extended Offset | In distribution |
| 186-00-58 | Group 3 | In distribution |
| 180-00-66 | Group 5 | In distribution |
| 161-01-06 | In distribution | |
| 146-36-52 | 36mm ID | In distribution |
| 168-50-10 | Size 10, Standard Offset | In distribution |
| 148-40-53 | 40mm ID | In distribution |
| 148-36-54 | 36mm ID | In distribution |
| 160-70-13 | Size 13 | In distribution |
| 160-70-11 | Size 11 | In distribution |
| 160-01-19 | Ext OFFSET | In distribution |
| 186-00-52 | Group 2 | In distribution |
| 186-02-54 | Group 2 | In distribution |
| 186-02-60 | Group 4 | In distribution |
| 161-09-10 | SIZE 10 | In distribution |
| 186-02-62 | Group 4 | In distribution |
| 161-07-00 | SIZE 9-12 | In distribution |
| 186-00-66 | Group 5 | In distribution |
| 186-00-60 | Group 4 | In distribution |
| 186-02-56 | Group 3 | In distribution |
| 161-09-14 | Angle 3 ° | In distribution |
| 161-02-10 | SIZE 10 | In distribution |
| 142-36-62 | 36mm ID | In distribution |
| 186-02-52 | Group 2 | In distribution |
| 146-36-54 | 36mm ID | In distribution |
| 148-36-52 | 36mm ID | In distribution |
| 160-51-11 | Extended Offset | In distribution |
| 161-09-18 | Reamer blade lead angle | In distribution |
| 160-50-15 | Standard Offset | In distribution |
| 142-40-63 | 40mm ID | In distribution |
| 186-00-48 | Group 1 | In distribution |
| 142-32-54 | 32mm ID | In distribution |
| 142-32-62 | 32mm ID | In distribution |
| 186-00-54 | Group 2 | In distribution |
| 186-02-48 | Group 1 | In distribution |
| 160-70-15 | Size 15 | In distribution |
| 186-00-64 | Group 5 | In distribution |
| 148-40-55 | 40mm ID | In distribution |
| 186-02-50 | Group 1 | In distribution |
| 161-09-13 | Reamer blade lead angle | In distribution |
| 161-02-20 | SIZE 20 | In distribution |
| 142-36-64 | 36mm ID | In distribution |
| 160-00-19 | STD OFFSET | In distribution |
| 146-40-55 | 40mm ID | In distribution |
| 161-07-04 | SIZE 16 | In distribution |
| 161-07-13 | SIZE 15 | In distribution |
| 160-71-13 | Size 13 | In distribution |
| 186-02-66 | Group 5 | In distribution |
| 146-40-53 | 40mm ID | In distribution |
| 186-02-64 | Group 5 | In distribution |
| 160-50-11 | Standard Offset | In distribution |
| 161-09-01 | SIZE 9/10 | In distribution |
| 160-51-15 | Extended Offset | In distribution |
| 142-40-55 | 40mm ID | In distribution |
| 160-51-09 | Extended Offset | In distribution |
| 161-05-01 | SIZE1 | In distribution |
| 142-40-53 | 40mm ID | In distribution |
| 161-05-05 | SIZE5 | In distribution |
| 186-02-58 | Group 3 | In distribution |
| 161-02-09 | SIZE 9 | In distribution |
| 161-08-14 | Angle 3 ° | In distribution |
| 186-02-68 | Group 5 | In distribution |
| 161-02-13 | SIZE 13 | In distribution |
| 142-32-52 | 32mm ID | In distribution |
| 160-51-13 | Extended Offset | In distribution |
| 142-40-65 | 40mm ID | In distribution |
| 186-00-68 | Group 5 | In distribution |
| 142-28-60 | 28mm ID | In distribution |
| 186-00-62 | Group 4 | In distribution |
| 142-36-54 | 36mm ID | In distribution |
| 186-00-56 | Group 3 | In distribution |
| 142-36-52 | 36mm ID | In distribution |
| 160-50-17 | Standard Offset | In distribution |
| 161-02-12 | SIZE 12 | In distribution |
| 160-71-11 | Size 11 | In distribution |
| 186-00-50 | Group 1 | In distribution |
| 186-03-48 | Group 1 | Withdrawn |
| 186-03-60 | Group 4 | Withdrawn |
| 146-32-54 | 32mm ID | Withdrawn |
| 186-03-66 | Group 5 | Withdrawn |
| 186-03-54 | Group 2 | Withdrawn |
| 186-01-58 | Group 3 | Withdrawn |
| 186-01-68 | Group 5 | Withdrawn |
| 186-01-66 | Group 5 | Withdrawn |
| 186-03-62 | Group 4 | Withdrawn |
| 146-28-51 | 28mm ID | Withdrawn |
| 186-01-62 | Group 4 | Withdrawn |
| 186-01-60 | Group 4 | Withdrawn |
| 186-03-58 | Group 3 | Withdrawn |
| 186-01-50 | Group 1 | Withdrawn |
| 186-01-52 | Group 2 | Withdrawn |
| 186-03-52 | Group 2 | Withdrawn |
| 186-03-56 | Group 3 | Withdrawn |
| 186-03-50 | Group 1 | Withdrawn |
| 186-01-64 | Group 5 | Withdrawn |
| 186-01-56 | Group 3 | Withdrawn |
| 142-28-62 | 28mm ID | Withdrawn |
| 146-32-52 | 32mm ID | Withdrawn |
| 186-03-64 | Group 5 | Withdrawn |
| 142-32-64 | 32mm ID | Withdrawn |
| 186-01-48 | Group 1 | Withdrawn |
| 186-01-54 | Group 2 | Withdrawn |
| 186-03-68 | Group 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221323 | 2023-05-19 |
| K190890 | 2019-10-22 |
| K182462 | 2018-11-08 |
| K181532 | 2018-09-04 |
| K150066 | 2015-07-20 |
| K141821 | 2014-08-28 |
| K140674 | 2014-06-30 |
| K121392 | 2013-01-16 |
| K103012 | 2010-11-10 |
| K102487 | 2010-11-08 |
| K083392 | 2008-12-17 |
| K070479 | 2007-03-15 |
| K063279 | 2006-11-29 |
| K060107 | 2006-02-06 |
| K052787 | 2005-12-27 |
| K051858 | 2005-12-01 |
| K050398 | 2005-11-18 |
| K051682 | 2005-07-19 |
| K042842 | 2004-11-09 |
| K931617 | 1994-06-14 |
| K914574 | 1992-01-13 |
Recalls Naming This Product
22 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 | 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. | 58158 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 | 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 | 2016-05-26 | 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 | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
| Exactech, Inc. | 510(k) number | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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. | 98 | 2019-08-05 |
| 2014-03-07 | Class II | Component design/selection | The femoral stem is lacking specified plasma coating. | 10 | 2014-08-04 |
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.