Profemur®
Profemur® Renaissance® Classic STD Flare SZ 15 V8DG Long Neck
5manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), 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 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140676 |
| Record published | 2015-10-20 |
| Record revised | 2018-07-06 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRTLSL25 | In distribution | |
| PRLX5810 | In distribution | |
| PLLSS013 | In distribution | |
| PRFC0011 | In distribution | |
| PRFC0013 | In distribution | |
| PLLES015 | In distribution | |
| LUXR5814 | In distribution | |
| PRTLEL31 | In distribution | |
| PHAC1252 | In distribution | |
| PRFC0017 | In distribution | |
| PRLX5818 | In distribution | |
| LUXR5813 | In distribution | |
| PHAC1212 | In distribution | |
| PLLES013 | In distribution | |
| LUXR5816 | In distribution | |
| PLLER010 | In distribution | |
| PRTLEL25 | In distribution | |
| PRTLSL23 | In distribution | |
| PLLER014 | In distribution | |
| PLLES017 | In distribution | |
| LUXR5818 | In distribution | |
| PLLSR016 | In distribution | |
| PHAC1214 | In distribution | |
| PRTLEL21 | In distribution | |
| PLLSS011 | In distribution | |
| PRLX5812 | In distribution | |
| PLLSS017 | In distribution | |
| PRTLEL27 | In distribution | |
| LUXR5817 | In distribution | |
| PHAC1234 | In distribution | |
| LUXR5820 | In distribution | |
| PLLSR012 | In distribution | |
| PHAC1222 | In distribution | |
| PRTLSL27 | In distribution | |
| PHAC1202 | In distribution | |
| PLLSR010 | In distribution | |
| PHAC1232 | In distribution | |
| PRLX5816 | In distribution | |
| PRTLSL31 | In distribution | |
| PRFC0015 | In distribution | |
| PLLSR014 | In distribution | |
| PLLER016 | In distribution | |
| PHAC1224 | In distribution | |
| PLLSS015 | In distribution | |
| PRTLSL29 | In distribution | |
| LUXR5815 | In distribution | |
| PRTLEL23 | In distribution | |
| PRLX5814 | In distribution | |
| PLLES011 | In distribution | |
| PRTLSL21 | In distribution | |
| PHAC1252 | In distribution | |
| PRTLEL29 | In distribution | |
| PLLER012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 100 |
| Reflection | Smith & Nephew, Inc. | 89 |
| Delta | Limacorporate | 44 |
| Onvoy | Globus Medical, Inc. | 40 |
| Restoration | Howmedica Osteonics Corp | 39 |
| Dynasty | Microport Orthopedics Inc. | 28 |
| Delta Liners & Accessories | Limacorporate | 27 |
| R3, Stiktite | Smith & Nephew, Inc. | 26 |
| Biolox Delta | Limacorporate | 19 |
| Tri-plus | Ortho Development Corp. | 16 |
| Trident | Howmedica Osteonics Corp | 15 |
Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201157 | 2021-08-24 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-08-04 | Class I | Device Design | Unexpected rate of postoperative fractures resulting in the need for revision surgery. | 10,489 units | 2018-08-17 |
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.