Acumatch a Series
64 catalogue numbers from 128-01-64, listed by Exactech, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
64catalogue numbers in this listing
8510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K000242 |
| Record published | 2015-08-10 |
| Record revised | 2025-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Sizes | Lumen/inner diameter 22 to 36 mm; outer diameter 42 to 70 mm |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 128-01-64 | Outer Diameter 64 mm | In distribution |
| 128-01-46 | Outer Diameter 46 mm | In distribution |
| 128-01-48 | Outer Diameter 48 mm | In distribution |
| 128-01-66 | Outer Diameter 66 mm | In distribution |
| 128-01-60 | Outer Diameter 60 mm | In distribution |
| 138-36-09 | +5mm Lateralized | In distribution |
| 132-36-08 | 15 Degrees | In distribution |
| 138-36-10 | +5mm Lateralized | In distribution |
| 128-01-44 | Outer Diameter 44 mm | In distribution |
| 128-01-68 | Outer Diameter 68 mm | In distribution |
| 128-01-52 | Outer Diameter 52 mm | In distribution |
| 128-01-70 | Outer Diameter 70 mm | In distribution |
| 128-01-50 | Outer Diameter 50 mm | In distribution |
| 128-01-54 | Outer Diameter 54 mm | In distribution |
| 128-01-62 | Outer Diameter 62 mm | In distribution |
| 128-01-58 | Outer Diameter 58 mm | In distribution |
| 138-36-08 | +5mm Lateralized | In distribution |
| 128-01-56 | Outer Diameter 56 mm | In distribution |
| 132-22-03 | 15 Degrees | In distribution |
| 132-32-29 | 15 Degrees | Withdrawn |
| 132-32-27 | 15 Degrees | Withdrawn |
| 132-28-24 | 15 Degrees | Withdrawn |
| 130-28-26 | Size F | Withdrawn |
| 132-28-28 | 15 Degrees | Withdrawn |
| 138-28-29 | +5mm Lateralized | Withdrawn |
| 138-36-29 | +5mm Lateralized | Withdrawn |
| 130-36-28 | Size H | Withdrawn |
| 132-28-25 | 15 Degrees | Withdrawn |
| 134-28-27 | 20 Degrees | Withdrawn |
| 134-28-29 | 20 Degrees | Withdrawn |
| 138-36-30 | +5mm Lateralized | Withdrawn |
| 130-28-25 | Size E | Withdrawn |
| 132-36-28 | 15 Degrees | Withdrawn |
| 130-28-28 | Size H | Withdrawn |
| 132-28-29 | 15 Degrees | Withdrawn |
| 132-32-28 | 15 Degrees | Withdrawn |
| 130-28-30 | Size K | Withdrawn |
| 132-36-30 | 15 Degrees | Withdrawn |
| 130-32-28 | Size H | Withdrawn |
| 132-36-10 | 15 Degrees | Withdrawn |
| 130-32-30 | Size K | Withdrawn |
| 134-28-26 | 20 Degrees | Withdrawn |
| 134-28-25 | 20 Degrees | Withdrawn |
| 130-36-29 | Size J | Withdrawn |
| 130-28-29 | Size J | Withdrawn |
| 132-28-04 | 15 Degrees | Withdrawn |
| 130-32-29 | Size J | Withdrawn |
| 138-28-26 | +5mm Lateralized | Withdrawn |
| 138-28-30 | +5mm Lateralized | Withdrawn |
| 120-01-42 | Outer Diameter 42 mm | Withdrawn |
| 132-36-09 | 15 Degrees | Withdrawn |
| 130-36-30 | Size K | Withdrawn |
| 138-28-27 | +5mm Lateralized | Withdrawn |
| 138-28-28 | +5mm Lateralized | Withdrawn |
| 138-28-25 | +5mm Lateralized | Withdrawn |
| 132-28-27 | 15 Degrees | Withdrawn |
| 132-28-26 | 15 Degrees | Withdrawn |
| 132-36-29 | 15 Degrees | Withdrawn |
| 138-36-28 | +5mm Lateralized | Withdrawn |
| 134-28-30 | 20 Degrees | Withdrawn |
| 132-28-30 | 15 Degrees | Withdrawn |
| 130-28-27 | Size G | Withdrawn |
| 134-28-28 | Size H | Withdrawn |
| 130-32-27 | Size G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243839 | 2025-03-10 |
| K162732 | 2017-04-26 |
| K153649 | 2016-08-31 |
| K113320 | 2012-03-16 |
| K080980 | 2008-05-06 |
| K040613 | 2004-06-04 |
| K000242 | 2000-02-16 |
| K990197 | 1999-02-04 |
Recalls Naming This Product
15 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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. | 136 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 | 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. | UDI-DI | 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 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2017-10-09 | Class II | Error in labeling | Wrong device description of the label identifying the implant | 34 | 2019-08-06 |
| 2015-09-23 | Class II | Under Investigation by firm | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. | 8 | 2017-03-01 |
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.