Conformis Hip System
Stem, Collared, HIP, Size 12, 132 DEG, 29.0 MM
8manufacturers in China registered for this device type
51catalogue numbers in this listing
1recall
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 | ConforMIS, 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 | Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-12-12 |
| Record revised | 2022-09-16 (version 7) |
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 |
| Sizes | Angle 127 to 132 °; length 29 to 36.5 mm; outer diameter 46 to 66 mm; lumen/inner diameter 36.5 mm |
| Distribution end date | 2022-08-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HBS033C12201 | Length 29 mm | In distribution |
| HCC032B05901 | Outer Diameter 59 mm | In distribution |
| HBS033C14401 | Length 29 mm | In distribution |
| HBS033C16401 | Length 36.5 mm | In distribution |
| HCC032B06601 | Outer Diameter 66 mm | In distribution |
| HBS033C16101 | Length 29 mm | In distribution |
| HCC032B05101 | Outer Diameter 51 mm | In distribution |
| HBS033C13101 | Length 29 mm | In distribution |
| HBS033C15301 | Length 36.5 mm | In distribution |
| HBS033C13201 | Length 29 mm | In distribution |
| HBS033C14301 | Length 36.5 mm | In distribution |
| HBS033C10401 | Length 36.5 mm | In distribution |
| HCC032B05201 | Outer Diameter 52 mm | In distribution |
| HCC032B04601 | Outer Diameter 46 mm | In distribution |
| HCC032B06201 | Outer Diameter 62 mm | In distribution |
| HBS033C11301 | Lumen/Inner Diameter 36.5 mm | In distribution |
| HCC032B05001 | Outer Diameter 50 mm | In distribution |
| HBS033C14101 | Length 29 mm | In distribution |
| HCC032B05501 | Outer Diameter 55 mm | In distribution |
| HBS033C11201 | Length 29 mm | In distribution |
| HCC032B06301 | Outer Diameter 63 mm | In distribution |
| HCC032B04701 | Outer Diameter 47 mm | In distribution |
| HBS033C15401 | Length 36.5 mm | In distribution |
| HCC032B06101 | Outer Diameter 61 mm | In distribution |
| HCC032B05701 | Outer Diameter 57 mm | In distribution |
| HBS033C13401 | Length 36.5 mm | In distribution |
| HBS033C12101 | Length 29 mm | In distribution |
| HBS033C13301 | Length 36.5 mm | In distribution |
| HCC032B05601 | Outer Diameter 56 mm | In distribution |
| HBS033C16301 | Length 36.5 mm | In distribution |
| HCC032B05401 | Outer Diameter 54 mm | In distribution |
| HBS033C10101 | Length 29 mm | In distribution |
| 1080-114 | In distribution | |
| HCC032B04901 | Outer Diameter 49 mm | In distribution |
| HBS033C11101 | Length 29 mm | In distribution |
| HCC032B04801 | Outer Diameter 48 mm | In distribution |
| HCC032B06501 | Outer Diameter 65 mm | In distribution |
| HBS033C12401 | Length 36.5 mm | In distribution |
| HCC032B06001 | Outer Diameter 60 mm | In distribution |
| HCC032B06401 | Outer Diameter 64 mm | In distribution |
| HBS033C15101 | Angle 127 ° | In distribution |
| HCC032B05301 | Outer Diameter 53 mm | In distribution |
| HBS033C10201 | Length 29 mm | In distribution |
| HBS033C15201 | Length 29 mm | In distribution |
| HBS033C14201 | Length 29 mm | In distribution |
| HCC032B05801 | Outer Diameter 58 mm | In distribution |
| HBS033C12301 | Length 36.5 mm | In distribution |
| HBS033C10301 | Length 36.5 mm | In distribution |
| HBS033C16201 | Length 29 mm | In distribution |
| 1080-117 | Withdrawn | |
| 1080-115 | Withdrawn |
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 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
| NovoHip Total Hip System | Novosource, LLC | 28 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/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 |
|---|---|---|---|---|
| 2023-06-16 | Class II | Error in labeling | 30mm screws were labeled as 25mm screws. | 25 units |
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.