Stratum Ankle
Stratum Ankle Non-Locking Screw Non-Sterile 5.0mmX48mm
31manufacturers in China registered for this device type
312catalogue numbers in this listing
6510(k) clearances naming this product code
18recalls 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 | Medartis Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K212640 |
| Record published | 2023-05-26 |
| Record revised | 2025-10-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2025-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SALS5020NS | In distribution | |
| SALS5018NS | Withdrawn | |
| SALS3532S | Withdrawn | |
| SACAN6090 | Withdrawn | |
| SANLS5048NS | Withdrawn | |
| SANLS5056NS | Withdrawn | |
| SALS3544S | Withdrawn | |
| SALS5038S | Withdrawn | |
| SANLS5022NS | Withdrawn | |
| SANLS3550S | Withdrawn | |
| SANLS3562NS | Withdrawn | |
| SANLS5034NS | Withdrawn | |
| SANLS5074S | Withdrawn | |
| SANLS3542NS | Withdrawn | |
| SALS5036NS | Withdrawn | |
| SALS3574S | Withdrawn | |
| SANLS3538NS | Withdrawn | |
| SALS5068NS | Withdrawn | |
| SALS5080S | Withdrawn | |
| SANLS3514S | Withdrawn | |
| SALS3530S | Withdrawn | |
| SALS3524NS | Withdrawn | |
| SACAN6026 | Withdrawn | |
| SANLS3542S | Withdrawn | |
| SANLS5028NS | Withdrawn | |
| SANLS3528S | Withdrawn | |
| SACAN6044 | Withdrawn | |
| SALS3548S | Withdrawn | |
| SALS5076S | Withdrawn | |
| SANLS3524NS | Withdrawn | |
| SALS5030S | Withdrawn | |
| SALS5010NS | Withdrawn | |
| SALS5014NS | Withdrawn | |
| SANLS3568NS | Withdrawn | |
| SANLS5058NS | Withdrawn | |
| SANLS5070S | Withdrawn | |
| SALS5046S | Withdrawn | |
| SANLS5042NS | Withdrawn | |
| SALS5076NS | Withdrawn | |
| SALS5062S | Withdrawn | |
| SALS5038NS | Withdrawn | |
| SANLS5016NS | Withdrawn | |
| SANLS5076NS | Withdrawn | |
| SACAN6042 | Withdrawn | |
| SALS3522S | Withdrawn | |
| SALS5034NS | Withdrawn | |
| SANLS5040NS | Withdrawn | |
| SANLS3546S | Withdrawn | |
| SANLS5016S | Withdrawn | |
| SANLS5048S | Withdrawn | |
| SALS5042NS | Withdrawn | |
| SALS5064S | Withdrawn | |
| SALS5028S | Withdrawn | |
| SANLS5056S | Withdrawn | |
| SANLS3540NS | Withdrawn | |
| SANLS3568S | Withdrawn | |
| SACAN6030 | Withdrawn | |
| SANLS5040S | Withdrawn | |
| SANLS5068S | Withdrawn | |
| SANLS5060S | Withdrawn | |
| SALS3566NS | Withdrawn | |
| SALS3576S | Withdrawn | |
| SALS5012S | Withdrawn | |
| SANLS3556S | Withdrawn | |
| SALS3524S | Withdrawn | |
| SALS5050S | Withdrawn | |
| SANLS3532NS | Withdrawn | |
| SANLS5024S | Withdrawn | |
| SANLS3578S | Withdrawn | |
| SALS3558NS | Withdrawn | |
| SANLS5014S | Withdrawn | |
| SANLS5066NS | Withdrawn | |
| SANLS3546NS | Withdrawn | |
| SALS5074S | Withdrawn | |
| SALS3556NS | Withdrawn | |
| SALS3568S | Withdrawn | |
| SALS3546NS | Withdrawn | |
| SALS5034S | Withdrawn | |
| SANLS3540S | Withdrawn | |
| SALS5026S | Withdrawn | |
| SANLS5054S | Withdrawn | |
| SALS3512S | Withdrawn | |
| SALS5058NS | Withdrawn | |
| SANLS3558NS | Withdrawn | |
| SALS3510NS | Withdrawn | |
| SACAN6070 | Withdrawn | |
| SALS3558S | Withdrawn | |
| SANLS5044NS | Withdrawn | |
| SANLS3570S | Withdrawn | |
| SALS3548NS | Withdrawn | |
| SANLS3572S | Withdrawn | |
| SALS5056S | Withdrawn | |
| SANLS3570NS | Withdrawn | |
| SACAN6052 | Withdrawn | |
| SALS3516NS | Withdrawn | |
| SALS3536S | Withdrawn | |
| SALS3538NS | Withdrawn | |
| SALS3550S | Withdrawn | |
| SANLS5030S | Withdrawn | |
| SALS5072S | Withdrawn | |
| SACAN6060 | Withdrawn | |
| SANLS3578NS | Withdrawn | |
| SANLS5046NS | Withdrawn | |
| SALS3578S | Withdrawn | |
| SALS5072NS | Withdrawn | |
| SALS3552S | Withdrawn | |
| SALS5044NS | Withdrawn | |
| SANLS3574NS | Withdrawn | |
| SALS5048S | Withdrawn | |
| SALS5050NS | Withdrawn | |
| SANLS5042S | Withdrawn | |
| SANLS3520NS | Withdrawn | |
| SANLS5020S | Withdrawn | |
| SALS5064NS | Withdrawn | |
| SALS3570S | Withdrawn | |
| SALS3550NS | Withdrawn | |
| SANLS5064NS | Withdrawn | |
| SALS3536NS | Withdrawn | |
| SALS5012NS | Withdrawn | |
| SALS3516S | Withdrawn | |
| SALS3518S | Withdrawn | |
| SANLS5010S | Withdrawn | |
| SALS5078S | Withdrawn | |
| SALS3564S | Withdrawn | |
| SALS5070NS | Withdrawn | |
| SACAN6036 | Withdrawn | |
| SANLS3562S | Withdrawn | |
| SANLS5052S | Withdrawn | |
| SANLS5072S | Withdrawn | |
| SANLS3530S | Withdrawn | |
| SANLS3560S | Withdrawn | |
| SANLS5052NS | Withdrawn | |
| SALS3522NS | Withdrawn | |
| SANLS5038S | Withdrawn | |
| SANLS5066S | Withdrawn | |
| SANLS5074NS | Withdrawn | |
| SANLS3560NS | Withdrawn | |
| SANLS3536S | Withdrawn | |
| SANLS3532S | Withdrawn | |
| SANLS5024NS | Withdrawn | |
| SANLS5020NS | Withdrawn | |
| SACAN6028 | Withdrawn | |
| SACAN6080 | Withdrawn | |
| SALS3580NS | Withdrawn | |
| SALS5040NS | Withdrawn | |
| SANLS5058S | Withdrawn | |
| SALS3514NS | Withdrawn | |
| SALS3512NS | Withdrawn | |
| SALS5026NS | Withdrawn | |
| SANLS5072NS | Withdrawn | |
| SALS5040S | Withdrawn | |
| SALS3554S | Withdrawn | |
| SALS5028NS | Withdrawn | |
| SANLS3510S | Withdrawn | |
| SANLS3514NS | Withdrawn | |
| SALS3562S | Withdrawn | |
| SANLS3512S | Withdrawn | |
| SANLS3552S | Withdrawn | |
| SALS3544NS | Withdrawn | |
| SANLS3512NS | Withdrawn | |
| SALS5070S | Withdrawn | |
| SANLS5012NS | Withdrawn | |
| SALS5074NS | Withdrawn | |
| SANLS5038NS | Withdrawn | |
| SACAN6046 | Withdrawn | |
| SALS5068S | Withdrawn | |
| SANLS3538S | Withdrawn | |
| SANLS5032S | Withdrawn | |
| SALS3540S | Withdrawn | |
| SALS3564NS | Withdrawn | |
| SANLS3564S | Withdrawn | |
| SANLS3554NS | Withdrawn | |
| SANLS5060NS | Withdrawn | |
| SALS3576NS | Withdrawn | |
| SALS3574NS | Withdrawn | |
| SACAN6075 | Withdrawn | |
| SALS5058S | Withdrawn | |
| SANLS5036S | Withdrawn | |
| SANLS5026NS | Withdrawn | |
| SACAN6085 | Withdrawn | |
| SANLS3580NS | Withdrawn | |
| SANLS5030NS | Withdrawn | |
| SANLS3544S | Withdrawn | |
| SALS3520S | Withdrawn | |
| SANLS3554S | Withdrawn | |
| SANLS3524S | Withdrawn | |
| SANLS3574S | Withdrawn | |
| SANLS3530NS | Withdrawn | |
| SANLS3548S | Withdrawn | |
| SALS3538S | Withdrawn | |
| SALS3510S | Withdrawn | |
| SANLS3516S | Withdrawn | |
| SANLS5032NS | Withdrawn | |
| SALS5018S | Withdrawn | |
| SALS3572NS | Withdrawn | |
| SALS3514S | Withdrawn | |
| SANLS3548NS | Withdrawn | |
| SALS3534NS | Withdrawn | |
| SANLS5068NS | Withdrawn | |
| SANLS3522S | Withdrawn | |
| SALS5016S | Withdrawn | |
| SALS3526S | Withdrawn | |
| SANLS5078S | Withdrawn | |
| SALS3556S | Withdrawn | |
| SALS5060NS | Withdrawn | |
| SALS5060S | Withdrawn | |
| SANLS3552NS | Withdrawn | |
| SALS5032NS | Withdrawn | |
| SALS3546S | Withdrawn | |
| SALS5036S | Withdrawn | |
| SALS5054S | Withdrawn | |
| SANLS5022S | Withdrawn | |
| SANLS5062S | Withdrawn | |
| SALS5046NS | Withdrawn | |
| SALS5010S | Withdrawn | |
| SALS5030NS | Withdrawn | |
| SALS3560S | Withdrawn | |
| SANLS3576S | Withdrawn | |
| SANLS5026S | Withdrawn | |
| SANLS3534S | Withdrawn | |
| SANLS3534NS | Withdrawn | |
| SALS5016NS | Withdrawn | |
| SANLS5012S | Withdrawn | |
| SALS3526NS | Withdrawn | |
| SANLS3518S | Withdrawn | |
| SALS5022NS | Withdrawn | |
| SALS3578NS | Withdrawn | |
| SANLS3516NS | Withdrawn | |
| SANLS5070NS | Withdrawn | |
| SALS5044S | Withdrawn | |
| SANLS5018S | Withdrawn | |
| SANLS5054NS | Withdrawn | |
| SANLS5050NS | Withdrawn | |
| SANLS5010NS | Withdrawn | |
| SANLS3572NS | Withdrawn | |
| SALS3566S | Withdrawn | |
| SALS3532NS | Withdrawn | |
| SALS3520NS | Withdrawn | |
| SANLS5076S | Withdrawn | |
| SALS5048NS | Withdrawn | |
| SALS5078NS | Withdrawn | |
| SALS3562NS | Withdrawn | |
| SANLS3556NS | Withdrawn | |
| SANLS5080NS | Withdrawn | |
| SALS3560NS | Withdrawn | |
| SANLS5028S | Withdrawn | |
| SANLS5014NS | Withdrawn | |
| SANLS3576NS | Withdrawn | |
| SANLS5044S | Withdrawn | |
| SANLS3520S | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K260934 | 2026-04-17 |
| K232251 | 2023-11-03 |
| K202589 | 2020-11-06 |
| K133460 | 2013-12-18 |
| K110658 | 2011-06-02 |
| K992106 | 1999-09-17 |
Recalls
18 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 |
|---|---|---|---|---|---|
| 2026-04-24 | Class II | Under Investigation by firm | The cannulation of the CCS screw is not centered. | 13 units | |
| 2026-01-09 | Class II | Labeling mix-ups | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | 0 | |
| 2026-01-09 | Class II | Labeling mix-ups | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. | 126 | |
| 2024-04-12 | Class II | Process control | Screw is 16mm long instead of 22mm long. | 110 units | |
| 2022-02-10 | Class II | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | 285 units | 2024-10-10 |
| 2022-02-10 | Class II | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | 239 units | 2024-10-10 |
| 2022-02-10 | Class II | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | 459 units | 2024-10-10 |
| 2022-02-10 | Class II | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | 4 units | 2024-10-10 |
| 2022-02-10 | Class II | Nonconforming Material/Component | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery | 89 units | 2024-10-10 |
| 2022-01-13 | Class II | Device Design | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ remov | 23 units | 2024-05-24 |
| 2022-01-13 | Class II | Device Design | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ remov | 24 units | 2024-05-24 |
| 2021-03-26 | Class II | Under Investigation by firm | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended | 111 units | 2021-11-10 |
| 2021-03-26 | Class II | Under Investigation by firm | Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended | 123 units | 2021-11-10 |
| 2020-02-12 | Class II | Under Investigation by firm | Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant | 190 units | 2020-12-17 |
| 2019-11-11 | Class II | Packaging process control | Components 2mm shorter than indicated on the package label | 86 units | 2020-09-10 |
| 2019-11-11 | Class II | Packaging process control | Components 2mm shorter than indicated on the package label | 86 units | 2020-09-10 |
| 2019-11-11 | Class II | Packaging process control | Components 2mm shorter than indicated on the package label | 87 units | 2020-09-10 |
| 2014-10-01 | Class II | Process design | A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. | 44 | 2015-08-06 |
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.