Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Implant Assembler Body, With Neck Version Guide
9manufacturers in China registered for this device type
51catalogue 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 | 2026-03-19 |
| Record revised | 2026-02-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 9 to 27 mm; depth 11 to 13 mm; outer diameter 2 in |
| Distribution end date | 2024-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 161-10-11 | Outer Diameter 14 mm | In distribution |
| 161-10-01 | Outer Diameter 9 mm | In distribution |
| 01-003-02-0005 | In distribution | |
| 151-12-12 | 11mm X 165mm | In distribution |
| 161-10-19 | Outer Diameter 18 mm | In distribution |
| 161-10-09 | Outer Diameter 13 mm | In distribution |
| 161-02-00 | In distribution | |
| 01-003-06-0006 | In distribution | |
| 01-003-10-0002 | In distribution | |
| 161-10-04 | Outer Diameter 10.5 mm | In distribution |
| 189-12-07 | SIZE 7 | In distribution |
| 189-02-15 | SIZE 15 | In distribution |
| 103-07-02 | In distribution | |
| 189-12-15 | SIZE 15 | In distribution |
| 181-00-11 | GROUP1 | In distribution |
| 189-12-08 | SIZE 8 | In distribution |
| 01-003-04-0001 | In distribution | |
| 181-00-14 | GROUP 4 | In distribution |
| 161-10-09 | Outer Diameter 13 mm | In distribution |
| 161-00-30 | In distribution | |
| 161-10-17 | Outer Diameter 17 mm | In distribution |
| 103-07-01 | In distribution | |
| 161-10-11 | Outer Diameter 14 mm | In distribution |
| 161-10-12 | Outer Diameter 14.5 mm | In distribution |
| 01-003-04-0006 | Outer Diameter 2 in | In distribution |
| 161-10-06 | Outer Diameter 11.5 mm | In distribution |
| 01-003-06-0008 | In distribution | |
| 01-003-02-0007 | In distribution | |
| 161-00-24 | In distribution | |
| 121-01-01 | In distribution | |
| 151-10-26 | Reamer Outer Diameter | Withdrawn |
| 151-13-02 | Withdrawn | |
| 151-10-03 | STRAIGHT | Withdrawn |
| 151-50-27 | Outer Diameter 27 mm | Withdrawn |
| 187-00-00 | Withdrawn | |
| 153-21-00 | Outer Diameter 21 mm | Withdrawn |
| 153-23-02 | 23mm | Withdrawn |
| 151-13-01 | Withdrawn | |
| 153-25-01 | Outer Diameter 25 mm | Withdrawn |
| 187-00-01 | Withdrawn | |
| 187-05-11 | (proximal thickness of the rasp) | Withdrawn |
| 151-13-27 | Outer Diameter 27 mm | Withdrawn |
| 151-10-19 | STRAIGHT | Withdrawn |
| 151-10-14 | Reamer Outer Diameter | Withdrawn |
| 151-10-25 | Reamer Outer Diameter | Withdrawn |
| 151-50-04 | Withdrawn | |
| 187-02-13 | LARGE | Withdrawn |
| 151-10-24 | Reamer Outer Diameter | Withdrawn |
| 153-21-02 | MEDIUM | Withdrawn |
| 151-13-00 | Withdrawn | |
| 187-03-11 | GROUP 3 | Withdrawn |
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 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 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
32 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. | 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 | 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. | 58158 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. | 3793 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 | 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 | 2017-10-09 | Class II | Error in labeling | Wrong device description of the label identifying the implant | 34 | 2019-08-06 |
| 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 | 2013-09-11 | Class II | Employee error | Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. | 235 | 2014-08-04 |
| 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 |
| 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 |
| Exactech, Inc. | 510(k) number | 2006-07-21 | Not classified | Other | The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device. | 6 | 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.