Continuum® Trilogy® Allofit®
19 catalogue numbers from 00-8732-013-32, listed by Zimmer, Inc., United States, under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
19catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K093846 |
| Record published | 2016-07-19 |
| Record revised | 2020-12-21 (version 7) |
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 | Lumen/inner diameter 28 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-8732-013-32 | Size LL | In distribution |
| 00-8731-011-28 | Size JJ | In distribution |
| 00-8731-011-32 | Size JJ | In distribution |
| 00-8732-015-28 | Size NN | In distribution |
| 00-8732-016-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 00-8731-023-32 | Size V V | In distribution |
| 00-8732-009-32 | Size HH | In distribution |
| 00-8731-012-28 | Size KK | In distribution |
| 00-8732-016-32 | Size OO | In distribution |
| 00-8731-019-40 | Size RR | In distribution |
| 00-8731-018-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 00-8731-017-40 | Lumen/Inner Diameter 40 mm | In distribution |
| 00-8731-018-36 | Size QU | In distribution |
| 00-8732-018-32 | Size QU | In distribution |
| 00-8732-012-36 | Size KK | In distribution |
| 00-8732-014-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 00-8731-019-36 | Size RR | In distribution |
| 00-8731-021-40 | Lumen/Inner Diameter 40 mm | In distribution |
| 00-8732-018-36 | Lumen/Inner Diameter 36 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120370 | 2012-06-04 |
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.