Iconacy I-Hip
The ICONACY i-Hip femoral construct combines a collarless, tapered forged titanium-alloy stem with a cobalt-chrome modular head. The acetabular assembly consists of a hemispheric…
The ICONACY i-Hip femoral construct combines a collarless, tapered forged titanium-alloy stem with a cobalt-chrome modular head.
The acetabular assembly consists of a hemispheric titanium-alloy cup coupled with a highly cross-linked ultra-high-molecular-weight polyethylene liner.
Listed Item
GT Femoral Stem, Reduced Lateral, Size 17.5
Implant Construction and Fixation
The femoral stem and acetabular cup are porous-coated components intended for cementless press-fit fixation. The system indications include painful or disabled hip joints due to specified degenerative or traumatic conditions.
14manufacturers in China registered for this device type
82catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| 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 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Iconacy Orthopedic Implants, LLC, United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| 510(k) | K121034 |
| Record published | 2015-11-06 |
| Record revised | 2020-04-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 6.5 to 64 mm; width 8 to 21 mm; outer diameter 32 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-10202-002-01 | Outer Diameter 32 mm | In distribution |
| 01-10104-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10005-008-00 | Width 8 mm | In distribution |
| 01-10104-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10005-008-01 | Width 8 mm | In distribution |
| 01-10005-021-00 | Width 21 mm | In distribution |
| 01-10201-000-01 | Outer Diameter 28 mm | In distribution |
| 01-10005-014-00 | Width 14 mm | In distribution |
| 01-10005-010-01 | Width 10 mm | In distribution |
| 01-10005-011-01 | Width 11 mm | In distribution |
| 01-30303-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10005-019-02 | Width 19 mm | In distribution |
| 01-10104-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10005-016-01 | Width 16 mm | In distribution |
| 01-10201-004-01 | Outer Diameter 28 mm | In distribution |
| 01-10101-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10101-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10202-000-01 | Outer Diameter 32 µm | In distribution |
| 01-30303-054-00 | Outer Diameter 54 mm | In distribution |
| 01-10005-012-02 | Width 12 mm | In distribution |
| 01-10104-060-00 | Outer Diameter 60 mm | In distribution |
| 01-10104-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10101-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10005-008-02 | Width 8 mm | In distribution |
| 01-10101-060-00 | Outer Diameter 60 mm | In distribution |
| 01-30303-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10203-012-01 | Outer Diameter 36 mm | In distribution |
| 01-10005-017-00 | Width 17.5 mm | In distribution |
| 01-30303-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10005-010-02 | Width 10 mm | In distribution |
| 01-10101-000-00 | Outer Diameter 6.5 mm | In distribution |
| 01-10005-012-00 | Width 12 mm | In distribution |
| 01-10005-011-00 | Width 11 mm | In distribution |
| 01-10101-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10005-013-00 | Width 13 mm | In distribution |
| 01-10005-014-02 | Width 14 mm | In distribution |
| 01-10202-004-01 | Outer Diameter 32 mm | In distribution |
| 01-10101-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10101-050-00 | Outer Diameter 50 mm | In distribution |
| 01-10005-021-01 | Width 21 mm | In distribution |
| 01-10202-012-01 | Outer Diameter 32 mm | In distribution |
| 01-10005-011-02 | Width 11 mm | In distribution |
| 01-10104-048-00 | Outer Diameter 48 mm | In distribution |
| 01-30303-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10005-014-01 | Width 14 mm | In distribution |
| 01-10104-052-00 | Outer Diameter 52 mm | In distribution |
| 01-10301-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10005-016-00 | Width 16 mm | In distribution |
| 01-10005-015-00 | Width 15 mm | In distribution |
| 01-10005-013-02 | Width 13 mm | In distribution |
| 01-30303-048-00 | Outer Diameter 48 mm | In distribution |
| 01-10201-008-01 | Outer Diameter 28 mm | In distribution |
| 01-10203-002-01 | Outer Diameter 36 mm | In distribution |
| 01-10005-021-02 | Width 21 mm | In distribution |
| 01-10005-017-02 | Width 17.5 mm | In distribution |
| 01-30303-046-00 | Outer Diameter 46 mm | In distribution |
| 01-10201-012-01 | Outer Diameter 28 mm | In distribution |
| 01-10005-010-00 | Width 10 mm | In distribution |
| 01-10101-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10203-004-01 | Outer Diameter 36 mm | In distribution |
| 01-10005-016-02 | Width 16 mm | In distribution |
| 01-10005-012-01 | Width 12 mm | In distribution |
| 01-10005-015-01 | Width 15 mm | In distribution |
| 01-10104-058-00 | Outer Diameter 58 mm | In distribution |
| 01-10005-019-01 | Width 19 mm | In distribution |
| 01-30303-052-00 | Outer Diameter 52 mm | In distribution |
| 01-30303-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10005-009-01 | Width 9 mm | In distribution |
| 01-30303-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10005-019-00 | Width 19 mm | In distribution |
| 01-10005-013-01 | Width 13 mm | In distribution |
| 01-10005-015-02 | Width 15 mm | In distribution |
| 01-10201-002-01 | Outer Diameter 28 mm | In distribution |
| 01-10101-064-00 | Outer Diameter 64 mm | In distribution |
| 01-10202-008-01 | Outer Diameter 32 mm | In distribution |
| 01-10203-000-01 | Outer Diameter 36 mm | In distribution |
| 01-10104-062-00 | Outer Diameter 62 mm | In distribution |
| 01-10101-056-00 | Outer Diameter 56 mm | In distribution |
| 01-10005-009-00 | Width 9 mm | In distribution |
| 01-10203-008-01 | Outer Diameter 36 mm | In distribution |
| 01-10005-017-01 | Width 17.5 mm | In distribution |
| 01-10005-009-02 | Width 9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160266 | 2016-04-08 |
| K132572 | 2014-03-28 |
| K133228 | 2014-01-17 |
| K131279 | 2013-08-09 |
| K121034 | 2012-09-04 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.