Iconacy I-Hip
Hxlp Liner, 28MM I.D. X 60MM O.D., 10 DEG., +3MM
9manufacturers in China registered for this device type
154catalogue numbers in this listing
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 | Iconacy Orthopedic Implants, LLC, United States |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| 510(k) | K131279 |
| Record published | 2015-10-30 |
| Record revised | 2020-09-09 (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 |
| Sizes | Outer diameter 46 to 64 mm; length 15 to 50 mm; width 8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-10103-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10301-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10102-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10001-010-01 | In distribution | |
| 01-10103-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10306-060-00 | Outer Diameter 60 mm | In distribution |
| 01-30301-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10304-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10326-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10303-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10307-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10302-060-00 | Outer Diameter 60 mm | In distribution |
| 01-30301-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10326-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10001-009-01 | In distribution | |
| 01-10102-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10305-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10308-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10302-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10325-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10001-009-02 | In distribution | |
| 01-10103-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10325-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10103-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10304-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10901-015-00 | Length 15 mm | In distribution |
| 01-10304-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10304-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10325-062-00 | Outer Diameter 62 mm | In distribution |
| 01-30301-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10304-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10325-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10102-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10001-010-02 | In distribution | |
| 01-10304-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10305-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10001-011-01 | In distribution | |
| 01-10001-014-01 | In distribution | |
| 01-10308-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10306-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10103-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10303-050-00 | Outer Diameter 50 mm | In distribution |
| 01-30301-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10309-054-00 | Outer Diameter 54 mm | In distribution |
| 01-30301-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10308-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10307-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10104-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10301-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10326-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10302-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10301-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10309-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10327-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10303-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10326-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10001-012-01 | In distribution | |
| 01-10302-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10303-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10001-014-02 | In distribution | |
| 01-10325-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10001-016-01 | In distribution | |
| 01-10901-020-00 | Length 20 mm | In distribution |
| 01-30301-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10304-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10307-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10307-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10309-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10102-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10301-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10102-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10103-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10302-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10102-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10301-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10001-008-02 | Width 8 mm | In distribution |
| 01-10901-050-00 | Length 50 mm | In distribution |
| 01-10001-015-02 | In distribution | |
| 01-10001-015-01 | In distribution | |
| 01-30301-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10303-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10307-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10326-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10305-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10327-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10309-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10901-040-00 | Length 40 mm | In distribution |
| 01-10302-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10102–048-00 | Outer Diameter 48 mm | In distribution |
| 01-10301-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10309-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10001-013-01 | In distribution | |
| 01-10326-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10303-062-00 | Outer Diameter 62 mm | In distribution |
| 01-30301-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10303-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10901-030-00 | Length 30 mm | In distribution |
| 01-10001-008-01 | Width 8 mm | In distribution |
| 01-10901-045-00 | Length 45 mm | In distribution |
| 01-10325-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10309-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10304-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10901-025-00 | Length 25 mm | In distribution |
| 01-10306-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10327-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10305-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10103-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10305-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10001-013-02 | In distribution | |
| 01-10301-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10001-016-02 | In distribution | |
| 01-10306-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10305-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10102-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10326-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10305-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10103-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10306-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10305-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10301-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10306-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10327-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10301-052-00 | Outer Diameter 52 mm | In distribution |
| 01-30301-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10309-056-00 | Outer Diameter 56 mm | In distribution |
| 01-30301-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10102-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10302-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10103-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10102-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10308-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10303-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10103-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10303-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10302-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10306-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10325-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10001-011-02 | In distribution | |
| 01-10302-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10306-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10302-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10308-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10303-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10327-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10327-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10308-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10901-035-00 | Length 35 mm | In distribution |
| 01-10325-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10326-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10325-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10325-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10307-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10306-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10001-012-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| 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
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.