Continuum® Trilogy® Allofit® Vivacit-E®
22 catalogue numbers from 00-8852-012-36, listed by Zimmer, Inc., United States, under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented. 5 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| 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 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | OQI |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K120370 |
| Record published | 2015-09-17 |
| Record revised | 2020-06-18 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Lumen/inner diameter 22 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-8852-012-36 | Lumen/Inner Diameter 36 mm | In distribution |
| 00-8852-020-32 | Size SS | In distribution |
| 00-8852-015-28 | Size NN | In distribution |
| 00-8851-016-40 | Lumen/Inner Diameter 40 mm | In distribution |
| 00-8852-021-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 00-8851-021-36 | Lumen/Inner Diameter 36 mm | In distribution |
| 00-8852-011-32 | Size JJ | In distribution |
| 00-8852-006-22 | Size EE | In distribution |
| 00-8851-022-36 | Size UU | In distribution |
| 00-8852-017-32 | Lumen/Inner Diameter 32 mm | In distribution |
| 00-8852-006-28 | Size EE | In distribution |
| 00-8852-020-36 | Size SS | In distribution |
| 00-8852-010-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 00-8851-022-40 | Size UU | In distribution |
| 00-8851-019-40 | Size RR | In distribution |
| 00-8851-011-36 | Lumen/Inner Diameter 36 mm | In distribution |
| 00-8851-018-28 | Size QU | In distribution |
| 00-8851-016-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 00-8852-005-22 | Lumen/Inner Diameter 22 mm | In distribution |
| 00-8851-018-40 | Lumen/Inner Diameter 40 mm | In distribution |
| 00-8851-006-28 | Lumen/Inner Diameter 28 mm | In distribution |
| 00-8851-010-32 | Lumen/Inner Diameter 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 260 |
| Epore® XO | implantcast GmbH | 64 |
| G7® | Biomet Orthopedics | 50 |
| InSitu Hip System | Nextstep Arthropedix | 50 |
| G7 Acetabular Liner | Biomet Orthopedics | 47 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | implantcast GmbH | 40 |
| Novation | Exactech, Inc. | 37 |
| Trinity Acetabular Hip System with ECiMa Liners | Corin Limited | 28 |
| Procotyl® Prime | Microport Orthopedics Inc. | 25 |
| AcuMatch | Exactech, Inc. | 23 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 23 |
| G7® Longevity® | Zimmer, Inc. | 23 |
Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
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 |
|---|---|---|---|---|
| 2022-08-25 | Class II | Under Investigation by firm | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery | 56 US |
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.