Acumatch P Series
46 catalogue numbers from 118-00-06, 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
46catalogue 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) | K051335 |
| Record published | 2015-08-10 |
| Record revised | 2025-08-28 (version 4) |
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, serial number |
| Sizes | Length 130 to 160 mm |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 118-00-06 | Standard Offset | In distribution |
| 118-00-05 | Standard Offset | In distribution |
| 114-23-01 | Size 1 | In distribution |
| 114-23-06 | Size 6 | In distribution |
| 114-23-04 | Size 4 | In distribution |
| 118-41-03 | High Offset | In distribution |
| 114-23-05 | Size 5 | In distribution |
| 114-23-02 | Size 2 | In distribution |
| 114-23-03 | Size 3 | In distribution |
| 114-23-00 | Size 0 | In distribution |
| 118-00-07 | Standard Offset | In distribution |
| 118-00-04 | Standard Offset | In distribution |
| 118-00-03 | Standard Offset | In distribution |
| 118-00-00 | Standard Offset | Withdrawn |
| 118-41-01 | High Offset | Withdrawn |
| 118-41-02 | High Offset | Withdrawn |
| 118-40-07 | High Offset | Withdrawn |
| 118-01-01 | Standard Offset | Withdrawn |
| 114-01-01 | Size 1 | Withdrawn |
| 118-41-00 | High Offset | Withdrawn |
| 118-01-02 | Standard Offset | Withdrawn |
| 118-40-01 | High Offset | Withdrawn |
| 118-40-03 | High Offset | Withdrawn |
| 114-01-06 | Size 6 | Withdrawn |
| 118-40-06 | High Offset | Withdrawn |
| 114-01-05 | Size 5 | Withdrawn |
| 118-41-07 | High Offset | Withdrawn |
| 118-41-05 | High Offset | Withdrawn |
| 118-01-05 | Standard Offset | Withdrawn |
| 114-01-00 | Size 0 | Withdrawn |
| 114-01-02 | Size 2 | Withdrawn |
| 118-41-04 | High Offset | Withdrawn |
| 118-40-00 | High Offset | Withdrawn |
| 118-40-05 | High Offset | Withdrawn |
| 118-40-04 | High Offset | Withdrawn |
| 114-01-04 | Size 4 | Withdrawn |
| 118-40-02 | High Offset | Withdrawn |
| 118-01-00 | Standard Offset | Withdrawn |
| 118-41-06 | High Offset | Withdrawn |
| 118-01-07 | Standard Offset | Withdrawn |
| 118-00-01 | Standard Offset | Withdrawn |
| 118-01-06 | Standard Offset | Withdrawn |
| 118-01-04 | 12/14 Taper | Withdrawn |
| 114-01-03 | Size 3 | Withdrawn |
| 118-00-02 | Standard Offset | Withdrawn |
| 118-01-03 | Standard Offset | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 |
Recalls
3 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. | 136 devices | |
| 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.