Ribfix BLU System
RibFix Blu is a thoracic fixation system using locking bone plates and locking screws for chest-wall or sternal fractures and osteotomies. The screws lock into the plate to form a rigid…
RibFix Blu is a thoracic fixation system using locking bone plates and locking screws for chest-wall or sternal fractures and osteotomies. The screws lock into the plate to form a rigid fixation construct.
The titanium-alloy screws are offered in 2.4 and 2.7 mm diameters. The 2.4 mm range includes self-drilling and self-tapping tips, while the 2.7 mm screws are self-tapping.
Screw Sizes and Preparation
The described screw lengths span 7 to 16 mm. Components are supplied nonsterile and require sterilization by the user before implantation. Plate and screw selection follows the chest-wall reconstruction and the compatible RibFix Blu construct.
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K151173 |
| Record published | 2020-06-18 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76-2516 | In distribution | |
| 76-2510 | In distribution | |
| 76-2410-5PK | In distribution | |
| 76-2707 | In distribution | |
| 76-2412 | In distribution | |
| 76-2714 | In distribution | |
| 76-0035 | In distribution | |
| 76-2414-5PK | In distribution | |
| 76-2414 | In distribution | |
| 76-2712-5PK | In distribution | |
| 76-2516-5PK | In distribution | |
| 76-2514-5PK | In distribution | |
| 76-2716 | In distribution | |
| 76-2512 | In distribution | |
| 76-2510-5PK | In distribution | |
| 76-2416 | In distribution | |
| 76-2410 | In distribution | |
| 76-2712 | In distribution | |
| 76-2512-5PK | In distribution | |
| 76-2604 | In distribution | |
| 76-2708-5PK | In distribution | |
| 76-2710 | In distribution | |
| 76-2710 | Withdrawn | |
| 76-2510-5PK | Withdrawn | |
| 76-2508 | Withdrawn | |
| 76-2516 | Withdrawn | |
| 76-2507 | Withdrawn | |
| 76-2714-5PK | Withdrawn | |
| 76-2416-5PK | Withdrawn | |
| 76-2516-5PK | Withdrawn | |
| 76-2512 | Withdrawn | |
| 76-2412-5PK | Withdrawn | |
| 76-2510 | Withdrawn | |
| 76-2708-5PK | Withdrawn | |
| 76-2507-5PK | Withdrawn | |
| 76-2508-5PK | Withdrawn | |
| 76-2512-5PK | Withdrawn | |
| 76-2514 | Withdrawn | |
| 76-2407 | Withdrawn | |
| 76-2514-5PK | Withdrawn | |
| 76-2407-5PK | Withdrawn | |
| 76-2412 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151173 | 2015-05-26 |
| K111908 | 2011-11-29 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-05-17 | Not classified | Labeling mix-ups | On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labe | 927 | 2011-10-12 |
| 2009-09-15 | Not classified | Component change control | Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the dep | 15 pieces | 2010-01-23 |
| 2009-09-15 | Not classified | Component change control | Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the dep | 7 pieces | 2010-01-23 |
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.