IBS™
IBS 6.5-C+ Compression Screw, DIAM6.5 LG100 MM Long Thrd T25
31manufacturers in China registered for this device type
240catalogue numbers in this listing
6510(k) clearances naming this product code
5recalls on this code
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 SAS, France |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K131920 |
| Record published | 2015-08-28 |
| Record revised | 2025-12-15 (version 11) |
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 |
| Sizes | Length 9 to 120 mm; outer diameter 2 to 8 mm; lumen/inner diameter 3.5 mm |
| Distribution end date | 2026-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S35 ST220 | Length 20 mm | In distribution |
| S80 ST305 | In distribution | |
| S35 ST116 | Length 16 mm | In distribution |
| S80 ST180 | Length 80 mm | In distribution |
| S80 ST165 | Length 65 mm | In distribution |
| S65 ST275 | Outer Diameter 6.5 mm | In distribution |
| S45 ST255 | Length 55 mm | In distribution |
| S30 ST220 | Length 20 mm | In distribution |
| S30 ST230 | Length 30 mm | In distribution |
| S65 ST580 | Outer Diameter 6.5 mm | In distribution |
| S25 ST226 | Length 26 mm | In distribution |
| S20 ST015 | Length 15 mm | In distribution |
| S45 ST135 | Length 35 mm | In distribution |
| S45 ST230 | Length 30 mm | In distribution |
| S30 ST122 | Length 22 mm | In distribution |
| S45 ST265 | Length 65 mm | In distribution |
| S65 ST280 | Outer Diameter 6.5 mm | In distribution |
| S30 ST114 | Length 14 mm | In distribution |
| S65 ST165 | Length 65 mm | In distribution |
| S45 ST148 | Length 48 mm | In distribution |
| S35 ST124 | Length 24 mm | In distribution |
| S80 ST240 | Length 40 mm | In distribution |
| S25 ST214 | Length 14 mm | In distribution |
| S30 ST224 | Length 24 mm | In distribution |
| S30 ST130 | Length 30 mm | In distribution |
| S25 ST222 | Length 22 mm | In distribution |
| S65 ST230 | Length 30 mm | In distribution |
| S65 ST410 | Outer Diameter 6.5 mm | In distribution |
| S35 ST236 | Length 36 mm | In distribution |
| S30 ST120 | Length 20 mm | In distribution |
| S45 ST246 | Length 46 mm | In distribution |
| S20 ST028 | Outer Diameter 2.0 mm | In distribution |
| S25 ST028 | Length 28 mm | In distribution |
| S20 ST029 | Length 29 mm | In distribution |
| S45 ST142 | Length 42 mm | In distribution |
| S25 ST010 | In distribution | |
| S35 ST230 | Length 30 mm | In distribution |
| S65 ST305 | Outer Diameter 6.5 mm | In distribution |
| S25 ST030 | Length 30 mm | In distribution |
| S35 ST222 | Outer Diameter 3.5 mm | In distribution |
| S35 ST226 | Length 26 mm | In distribution |
| S35 ST216 | Outer Diameter 3.5 mm | In distribution |
| S30 ST132 | Length 32 mm | In distribution |
| S45 ST134 | Length 34 mm | In distribution |
| S30 ST112 | Length 12 mm | In distribution |
| S45 ST240 | Length 40 mm | In distribution |
| S20 ST012 | Outer Diameter 2.0 mm | In distribution |
| S45 ST170 | Length 70 mm | In distribution |
| S45 ST260 | Length 60 mm | In distribution |
| S65 ST120 | Length 20 mm | In distribution |
| S65 ST240 | Length 40 mm | In distribution |
| S65 ST260 | Length 60 mm | In distribution |
| S35 ST240 | Length 40 mm | In distribution |
| S80 ST280 | Length 80 mm | In distribution |
| S35 ST120 | Length 20 mm | In distribution |
| S20 ST022 | Outer Diameter 2.0 mm | In distribution |
| S45 ST132 | Length 32 mm | In distribution |
| S25 ST026 | Length 26 mm | In distribution |
| S45 ST124 | Length 24 mm | In distribution |
| S45 ST222 | Length 22 mm | In distribution |
| S30 ST216 | Length 16 mm | In distribution |
| S80 ST410 | In distribution | |
| S65 ST255 | Length 55 mm | In distribution |
| S65 ST290 | Outer Diameter 6.5 mm | In distribution |
| S65 ST220 | Length 20 mm | In distribution |
| S45 ST244 | Length 44 mm | In distribution |
| S65 ST570 | Outer Diameter 6.5 mm | In distribution |
| S45 ST236 | Length 36 mm | In distribution |
| S80 ST420 | In distribution | |
| S80 ST275 | Length 75 mm | In distribution |
| S65 ST320 | Length 120 mm | In distribution |
| S65 ST600 | Outer Diameter 6.5 mm | In distribution |
| S80 ST150 | Outer Diameter 8.0 mm | In distribution |
| S20 ST025 | Length 25 mm | In distribution |
| S20 ST019 | Length 19 mm | In distribution |
| S65 ST595 | Length 95 mm | In distribution |
| S25 ST020 | Length 20 mm | In distribution |
| S80 ST195 | Length 95 mm | In distribution |
| S20 ST010 | Outer Diameter 2.0 mm | In distribution |
| S65 ST590 | Outer Diameter 6.5 mm | In distribution |
| S65 ST300 | Length 100 mm | In distribution |
| S65 ST610 | Outer Diameter 6.5 mm | In distribution |
| S35 ST238 | Length 38 mm | In distribution |
| S45 ST225 | Length 25 mm | In distribution |
| S80 ST155 | Outer Diameter 8.0 mm | In distribution |
| S25 ST228 | Length 28 mm | In distribution |
| S80 ST185 | Length 85 mm | In distribution |
| S65 ST315 | Outer Diameter 6.5 mm | In distribution |
| S65 ST130 | Length 30 mm | In distribution |
| S25 ST018 | Length 18 mm | In distribution |
| S65 ST265 | Outer Diameter 6.5 mm | In distribution |
| S20 ST018 | Outer Diameter 2.0 mm | In distribution |
| S45 ST245 | Length 45 mm | In distribution |
| S80 ST405 | In distribution | |
| S35 ST232 | Length 32 mm | In distribution |
| S80 ST160 | Outer Diameter 8.0 mm | In distribution |
| S30 ST214 | Length 14 mm | In distribution |
| S30 ST134 | Length 34 mm | In distribution |
| S65 ST135 | Length 35 mm | In distribution |
| S80 ST140 | Length 40 mm | In distribution |
| S30 ST218 | Length 18 mm | In distribution |
| S65 ST605 | Length 105 mm | In distribution |
| S30 ST118 | Length 18 mm | In distribution |
| S65 ST615 | Length 115 mm | In distribution |
| S65 ST155 | Length 55 mm | In distribution |
| S45 ST248 | Length 48 mm | In distribution |
| S30 ST126 | Length 26 mm | In distribution |
| S20 ST017 | Length 17 mm | In distribution |
| S35 ST122 | Length 22 mm | In distribution |
| S65 ST125 | Length 25 mm | In distribution |
| S65 ST310 | Length 110 mm | In distribution |
| S45 ST144 | Length 44 mm | In distribution |
| S80 ST265 | Length 65 mm | In distribution |
| S65 ST400 | Outer Diameter 6.5 mm | In distribution |
| S45 ST130 | Length 30 mm | In distribution |
| S65 ST145 | Length 45 mm | In distribution |
| S80 ST400 | Length 100 mm | In distribution |
| S45 ST122 | Length 22 mm | In distribution |
| S25 ST216 | Length 16 mm | In distribution |
| S35 ST218 | Length 18 mm | In distribution |
| S80 ST295 | Length 95 mm | In distribution |
| S20 ST024 | Outer Diameter 2.0 mm | In distribution |
| S35 ST132 | Length 32 mm | In distribution |
| S65 ST420 | Outer Diameter 6.5 mm | In distribution |
| S80 ST270 | Length 70 mm | In distribution |
| S45 ST126 | Length 26 mm | In distribution |
| S25 ST016 | Outer Diameter 2.5 mm | In distribution |
| S20 ST013 | Length 13 mm | In distribution |
| S25 ST024 | Length 24 mm | In distribution |
| S20 ST026 | Outer Diameter 2.0 mm | In distribution |
| S20 ST021 | Length 21 mm | In distribution |
| S80 ST255 | Outer Diameter 8.0 mm | In distribution |
| S65 ST225 | Length 25 mm | In distribution |
| S45 ST224 | Length 24 mm | In distribution |
| S20 ST027 | Length 27 mm | In distribution |
| S45 ST238 | Length 38 mm | In distribution |
| S45 ST138 | Length 38 mm | In distribution |
| S45 ST128 | Length 28 mm | In distribution |
| S65 ST295 | Length 95 mm | In distribution |
| S45 ST250 | Length 50 mm | In distribution |
| S30 ST212 | Length 12 mm | In distribution |
| S80 ST170 | Length 70 mm | In distribution |
| S65 ST195 | Outer Diameter 6.5 mm | In distribution |
| S45 ST146 | Length 46 mm | In distribution |
| S30 ST116 | Length 16 mm | In distribution |
| S45 ST226 | Length 26 mm | In distribution |
| S25 ST022 | Length 22 mm | In distribution |
| S30 ST232 | Length 32 mm | In distribution |
| S30 ST128 | Length 28 mm | In distribution |
| S25 ST011 | In distribution | |
| S65 ST285 | Length 85 mm | In distribution |
| S35 ST140 | Length 40 mm | In distribution |
| S65 ST620 | Outer Diameter 6.5 mm | In distribution |
| S80 ST175 | Length 75 mm | In distribution |
| S25 ST218 | Length 18 mm | In distribution |
| S45 ST165 | Length 65 mm | In distribution |
| S80 ST245 | Length 45 mm | In distribution |
| S25 ST014 | Length 14 mm | In distribution |
| S65 ST585 | Length 85 mm | In distribution |
| S45 ST242 | Length 42 mm | In distribution |
| S35 ST228 | Length 28 mm | In distribution |
| S65 ST175 | Length 75 mm | In distribution |
| S25 ST212 | Length 12 mm | In distribution |
| S45 ST150 | Length 50 mm | In distribution |
| S45 ST232 | Length 32 mm | In distribution |
| S45 ST235 | Length 35 mm | In distribution |
| S20 ST030 | Outer Diameter 2.0 mm | In distribution |
| S80 ST145 | Outer Diameter 8.0 mm | In distribution |
| S35 ST126 | Length 26 mm | In distribution |
| S65 ST140 | Length 40 mm | In distribution |
| S45 ST234 | Length 34 mm | In distribution |
| S65 ST405 | Length 105 mm | In distribution |
| S65 ST415 | Length 115 mm | In distribution |
| S65 ST245 | Length 45 mm | In distribution |
| S65 ST185 | Outer Diameter 6.5 mm | In distribution |
| S80 ST285 | Length 85 mm | In distribution |
| S35 ST234 | Length 34 mm | In distribution |
| S65 ST270 | Outer Diameter 6.5 mm | In distribution |
| S65 ST190 | Length 90 mm | In distribution |
| S80 ST300 | Length 100 mm | In distribution |
| S45 ST220 | Length 20 mm | In distribution |
| S80 ST190 | Length 90 mm | In distribution |
| S20 ST020 | Outer Diameter 2.0 mm | In distribution |
| S20 ST011 | Length 11 mm | In distribution |
| S30 ST226 | Length 26 mm | In distribution |
| S35 ST128 | Length 28 mm | In distribution |
| S25 ST012 | Length 12 mm | In distribution |
| S45 ST125 | Length 25 mm | In distribution |
| S80 ST290 | Length 90 mm | In distribution |
| S20 ST016 | Outer Diameter 2.0 mm | In distribution |
| S30 ST222 | Outer Diameter 3.0 mm | In distribution |
| S80 ST310 | In distribution | |
| S25 ST220 | Outer Diameter 2.5 mm | In distribution |
| S30 ST124 | Length 24 mm | In distribution |
| S35 ST118 | Length 18 mm | In distribution |
| S30 ST228 | Outer Diameter 3.0 mm | In distribution |
| S65 ST565 | Length 65 mm | In distribution |
| S35 ST224 | Length 24 mm | In distribution |
| S65 ST160 | Length 60 mm | In distribution |
| S20 ST023 | Length 23 mm | In distribution |
| S80 ST315 | In distribution | |
| S65 ST150 | Length 50 mm | In distribution |
| S45 ST228 | Length 28 mm | In distribution |
| S80 ST250 | Length 50 mm | In distribution |
| S45 ST120 | Length 20 mm | In distribution |
| S80 ST260 | Outer Diameter 8.0 mm | In distribution |
| S20 ST014 | Outer Diameter 2.0 mm | In distribution |
| S30 ST234 | Outer Diameter 3.0 mm | In distribution |
| S45 ST145 | Length 45 mm | In distribution |
| S35 ST130 | Length 30 mm | In distribution |
| S45 ST140 | Outer Diameter 4.5 mm | In distribution |
| S65 ST250 | Length 50 mm | In distribution |
| S65 ST560 | Outer Diameter 6.5 mm | In distribution |
| S45 ST136 | Length 36 mm | In distribution |
| S65 ST235 | Outer Diameter 6.5 mm | In distribution |
| S45 ST155 | Length 55 mm | In distribution |
| S65 ST575 | Length 75 mm | In distribution |
| S25 ST224 | Length 24 mm | In distribution |
| S65 ST180 | Outer Diameter 6.5 mm | In distribution |
| S45 ST160 | Length 60 mm | In distribution |
| S80 ST415 | In distribution | |
| S65 ST170 | Length 70 mm | In distribution |
| S35 ST138 | Length 38 mm | In distribution |
| S45 ST270 | Length 70 mm | In distribution |
| S35 ST136 | Length 36 mm | In distribution |
| S35 ST134 | Length 34 mm | In distribution |
| S80 ST320 | In distribution | |
| S27 ST018 B | Outer Diameter 2.7 mm | Withdrawn |
| S27 ST016 B | Outer Diameter 2.7 mm | Withdrawn |
| S22 ST012 B | Length 12 mm | Withdrawn |
| S22 ST011 B | Outer Diameter 2.2 mm | Withdrawn |
| S22 ST010 B | Outer Diameter 2.2 mm | Withdrawn |
| S22 ST013 B | Outer Diameter 2.2 mm | Withdrawn |
| S27 ST020 B | Outer Diameter 2.7 mm | Withdrawn |
| S27 ST013 B | Outer Diameter 2.7 mm | Withdrawn |
| S22 ST014 B | Outer Diameter 2.2 mm | Withdrawn |
| S27 ST012 B | Outer Diameter 2.7 mm | Withdrawn |
| S27 ST011 B | Outer Diameter 2.7 mm | Withdrawn |
| S27 ST014 B | Outer Diameter 2.7 mm | Withdrawn |
| S22 ST009 B | Outer Diameter 2.2 mm | 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 |
|---|---|
| K170688 | 2017-11-28 |
| K170594 | 2017-05-10 |
| K160174 | 2016-10-06 |
| K132912 | 2014-07-30 |
| K131920 | 2014-05-01 |
| K132911 | 2014-04-04 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| In2Bones SAS | 510(k) number | 2024-01-26 | Class II | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by | 59 units | |
| In2Bones SAS | 510(k) number | 2024-01-26 | Class II | Process control | This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by | 63 units | |
| In2Bones SAS | 510(k) number | 2015-11-18 | Class II | Nonconforming Material/Component | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head. | 20 units | 2016-08-19 |
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 |
|---|---|---|---|---|---|
| 2015-03-09 | Class II | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | 35 units | 2016-05-19 |
| 2015-03-09 | Class II | Nonconforming Material/Component | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | 15 units | 2016-05-19 |
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.