Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
PILOT SHAFT, MILL GUIDE, METAPHYSEAL, 15mm x 165mm
15manufacturers in China registered for this device type
136catalogue 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) | K140674 |
| Record published | 2022-07-28 |
| Record revised | 2025-08-28 (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 9 to 36 mm; depth 8 to 11 mm; length 165 mm; width 8 mm |
| Distribution end date | 2025-08-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 189-00-00 | In distribution | |
| 01-019-01-1030 | Outer Diameter 30 mm | In distribution |
| 01-019-01-0026 | Outer Diameter 26 mm | In distribution |
| 01-019-01-1015 | Outer Diameter 15 mm | In distribution |
| 01-019-01-0015 | Outer Diameter 15 mm | In distribution |
| 01-019-01-0019 | Outer Diameter 19 mm | In distribution |
| 161-10-14 | Outer Diameter 15.5 mm | In distribution |
| 161-10-08 | Outer Diameter 12.5 mm | In distribution |
| 01-019-01-0017 | Outer Diameter 17 mm | In distribution |
| 161-02-02 | In distribution | |
| 161-05-00 | In distribution | |
| 01-019-01-1030 | Outer Diameter 30 mm | In distribution |
| 163-10-01 | In distribution | |
| 01-019-01-0028 | Outer Diameter 28 mm | In distribution |
| 01-019-01-0018 | Outer Diameter 18 mm | In distribution |
| 01-019-01-1014 | Outer Diameter 14 mm | In distribution |
| 101-13-02 | Small | In distribution |
| 01-019-01-1017 | Outer Diameter 17 mm | In distribution |
| 01-019-01-1016 | Outer Diameter 16 mm | In distribution |
| 163-02-06 | SIZE 6 | In distribution |
| 141-01-32 | Outer Diameter 32 mm | In distribution |
| 101-13-04 | Large | In distribution |
| 01-019-01-0020 | Outer Diameter 20 mm | In distribution |
| 01-019-01-1018 | Outer Diameter 18 mm | In distribution |
| 01-019-01-0016 | Outer Diameter 16 mm | In distribution |
| 01-019-01-1024 | Outer Diameter 24 mm | In distribution |
| 01-019-01-0019 | Outer Diameter 19 mm | In distribution |
| 01-019-01-1022 | Outer Diameter 22 mm | In distribution |
| 01-019-01-1015 | Outer Diameter 15 mm | In distribution |
| 01-019-01-0018 | Outer Diameter 18 mm | In distribution |
| 163-02-00 | In distribution | |
| 161-10-14 | Outer Diameter 15.5 mm | In distribution |
| 163-00-08 | In distribution | |
| 181-02-00 | In distribution | |
| 01-019-01-0024 | Outer Diameter 24 mm | In distribution |
| 163-02-04 | SIZE 4 | In distribution |
| 01-019-01-0014 | Outer Diameter 14 mm | In distribution |
| 01-019-01-0013 | Outer Diameter 13 mm | In distribution |
| 01-019-01-1028 | Outer Diameter 28 mm | In distribution |
| 163-02-00 | In distribution | |
| 189-02-13 | SIZE 13 | In distribution |
| 01-019-01-0017 | Outer Diameter 17 mm | In distribution |
| 01-019-03-0000 | In distribution | |
| 161-10-13 | Outer Diameter 15 mm | In distribution |
| 01-019-01-0024 | Outer Diameter 24 mm | In distribution |
| 01-019-01-1021 | Outer Diameter 21 mm | In distribution |
| 141-01-36 | Outer Diameter 36 mm | In distribution |
| 01-019-01-1018 | Outer Diameter 18 mm | In distribution |
| 01-019-01-0012 | Outer Diameter 12 mm | In distribution |
| 01-019-01-1017 | Outer Diameter 17 mm | In distribution |
| 163-00-01 | In distribution | |
| 161-10-08 | Outer Diameter 12.5 mm | In distribution |
| 01-019-01-1026 | Outer Diameter 26 mm | In distribution |
| 189-02-16 | SZ 16 | In distribution |
| 01-019-01-0023 | Outer Diameter 23 mm | In distribution |
| 181-00-13 | GROUP 3 | In distribution |
| 01-019-01-1019 | Outer Diameter 19 mm | In distribution |
| 161-10-18 | Outer Diameter 17.5 mm | In distribution |
| 01-019-01-1024 | Outer Diameter 24 mm | In distribution |
| 01-019-01-0026 | Outer Diameter 26 mm | In distribution |
| 161-02-02 | In distribution | |
| 161-10-13 | Outer Diameter 15 mm | In distribution |
| 01-019-01-0030 | Outer Diameter 30 mm | In distribution |
| 161-10-18 | Outer Diameter 17.5 mm | In distribution |
| 161-10-12 | Outer Diameter 14.5 mm | In distribution |
| 01-019-01-1022 | Outer Diameter 22 mm | In distribution |
| 01-019-01-0023 | Outer Diameter 23 mm | In distribution |
| 131-01-26 | Spherical Diameter | In distribution |
| 01-019-01-0020 | Outer Diameter 20 mm | In distribution |
| 163-02-01 | In distribution | |
| 01-019-01-0030 | Outer Diameter 30 mm | In distribution |
| 01-019-01-0028 | Outer Diameter 28 mm | In distribution |
| 01-019-01-1026 | Outer Diameter 26 mm | In distribution |
| 01-019-01-1001 | In distribution | |
| 01-019-01-0022 | Outer Diameter 22 mm | In distribution |
| 01-007-30-0000 | In distribution | |
| 01-019-01-0021 | Outer Diameter 21 mm | In distribution |
| 01-019-01-0012 | Outer Diameter 12 mm | In distribution |
| 01-019-01-1028 | Outer Diameter 28 mm | In distribution |
| 140-36-00 | +0mm Offset | In distribution |
| 141-01-32 | Outer Diameter 32 mm | In distribution |
| 01-019-03-0000 | In distribution | |
| 01-019-01-1019 | Outer Diameter 19 mm | In distribution |
| 01-019-01-0022 | Outer Diameter 22 mm | In distribution |
| 163-01-01 | In distribution | |
| 01-019-01-1020 | Outer Diameter 20 mm | In distribution |
| 161-10-01 | Outer Diameter 9 mm | In distribution |
| 01-019-01-0014 | Outer Diameter 14 mm | In distribution |
| 01-019-01-1014 | Outer Diameter 14 mm | In distribution |
| 01-019-01-1020 | Outer Diameter 20 mm | In distribution |
| 113-10-05 | In distribution | |
| 161-10-07 | Outer Diameter 12 mm | In distribution |
| 01-019-01-0015 | Outer Diameter 15 mm | In distribution |
| 01-019-01-1023 | Outer Diameter 23 mm | In distribution |
| 113-01-05 | SIZE 5 | In distribution |
| 189-02-09 | SIZE 9 | In distribution |
| 01-019-01-1021 | Outer Diameter 21 mm | In distribution |
| 01-019-01-0021 | Outer Diameter 21 mm | In distribution |
| 01-019-01-0013 | Outer Diameter 13 mm | In distribution |
| 01-019-01-0016 | Outer Diameter 16 mm | In distribution |
| 01-019-01-1001 | In distribution | |
| 01-019-01-0001 | In distribution | |
| 113-01-03 | SIZE 3 | In distribution |
| 01-019-01-1016 | Outer Diameter 16 mm | In distribution |
| 01-019-01-1023 | Outer Diameter 23 mm | In distribution |
| 01-019-01-0001 | In distribution | |
| 131-01-01 | In distribution | |
| 151-10-12 | Reamer Outer Diameter | Withdrawn |
| 151-15-00 | Withdrawn | |
| 151-10-13 | Reamer Outer Diameter | Withdrawn |
| 140-36-03 | Outer Diameter 36 mm | Withdrawn |
| 151-13-21 | Major Cone Diameter | Withdrawn |
| 187-01-00 | Withdrawn | |
| 151-10-21 | Outer Diameter 10.5 mm | Withdrawn |
| 153-25-02 | Outer Diameter 25 mm | Withdrawn |
| 187-04-08 | (proximal thickness of the rasp) | Withdrawn |
| 140-36-93 | -3.5mm Offset | Withdrawn |
| 187-02-08 | SMALL | Withdrawn |
| 151-10-16 | Outer Diameter 18 mm | Withdrawn |
| 187-04-11 | (proximal thickness of the rasp) | Withdrawn |
| 151-50-00 | Withdrawn | |
| 187-01-08 | Width 8 mm | Withdrawn |
| 153-21-01 | Outer Diameter 21 mm | Withdrawn |
| 151-13-23 | Major Cone Diameter | Withdrawn |
| 151-10-09 | STRAIGHT | Withdrawn |
| 151-50-05 | Withdrawn | |
| 151-00-09 | Withdrawn | |
| 151-14-15 | Mill Pilot Diameter | Withdrawn |
| 151-50-23 | Outer Diameter 23 mm | Withdrawn |
| 151-00-07 | LARGE | Withdrawn |
| 151-10-15 | Outer Diameter 17.5 mm | Withdrawn |
| 151-13-29 | Outer Diameter 29 mm | Withdrawn |
| 153-25-00 | EXTRA SMALL | Withdrawn |
| 151-14-13 | Length 165 mm | Withdrawn |
| 151-10-08 | Reamer Outer Diameter | Withdrawn |
| 151-13-31 | Outer Diameter 31 mm | 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 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
| RingLoc® Hip System | Biomet Orthopedics | 130 |
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
48 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. | 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 | 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 | 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 |
Showing 40 of 48.
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 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.