Fracture and Correction CoLag™
The CoLag screw provides internal fixation for bone fractures, fusions, osteotomies and non-unions. It can be used as a stand-alone lag screw or as part of a plate-and-screw construct. The…
The CoLag screw provides internal fixation for bone fractures, fusions, osteotomies and non-unions. It can be used as a stand-alone lag screw or as part of a plate-and-screw construct. The listed component is a 2.0 mm diameter, 12 mm long screw.
The screw is manufactured from titanium alloy. It belongs to the In2Bones Fracture and Correction System, which includes fixation plates, screws and surgical instruments. The CoLag family offers different diameters and lengths to suit different bones and fixation sites.
Listed Item
SCREW, Ø2.0X12.0 mm
Fixation Sites
The lag screws are indicated for bones including the humerus, radius, ulna, tibia, calcaneus and fibula, as well as metacarpals, metatarsals and phalanges. The subject range includes 2.0 mm screws from 8 to 55 mm long.
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 | IN2BONES USA, LLC, 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, Manufacturer |
| 510(k) | K180377 |
| Record published | 2018-08-06 |
| Record revised | 2025-08-04 (version 7) |
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 |
| Distribution end date | 2024-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P65 ST112 | Withdrawn | |
| P65 ST208 | Withdrawn | |
| P65 ST130 | Withdrawn | |
| P65 ST118 | Withdrawn | |
| P65 ST128 | Withdrawn | |
| P65 ST113 | Withdrawn | |
| P65 ST126 | Withdrawn | |
| P65 ST120 | Withdrawn | |
| P65 ST124 | Withdrawn | |
| P65 ST122 | Withdrawn | |
| P65 ST108 | Withdrawn | |
| P65 ST116 | Withdrawn | |
| P65 ST110 | Withdrawn | |
| P65 ST109 | Withdrawn | |
| P65 ST111 | Withdrawn | |
| P65 ST115 | Withdrawn | |
| P65 ST114 | Withdrawn | |
| P65 ST210 | 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 |
|---|---|
| K261154 | 2026-05-30 |
| K231236 | 2023-07-27 |
| K180377 | 2018-06-20 |
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 48 units | 2019-02-22 |
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 47 units | 2019-02-22 |
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.