MC-Subtalar™ II
MC-Subtalar II is a screw implant used to limit excessive pronation in children with flexible flat feet. It is placed in the calcaneus as part of an extra-articular subtalar correction…
MC-Subtalar II is a screw implant used to limit excessive pronation in children with flexible flat feet. It is placed in the calcaneus as part of an extra-articular subtalar correction while allowing subtalar joint motion.
The screw is partially threaded, cannulated and self-tapping, with a shaped shaft end for adjustment during surgery. Stainless steel and titanium alloy versions are available.
Listed Item
MC-Subtalar™ II Screw 10 35 T20 stainless steel
Sizes and Patient Group
The range includes lengths of 25, 30 and 35 mm with head diameters of 6, 8 or 10 mm. The listed configuration is stainless steel. The system is intended for children from six to under thirteen years of age whose flexible deformity remains manually correctable and meets the specified treatment criteria.
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 | Merete Gmbh, Germany |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160548 |
| Record published | 2016-06-10 |
| Record revised | 2025-06-20 (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 | Outer diameter 6 to 35 mm; length 6 to 35 mm |
| Distribution end date | 2020-11-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 35 T20 | Outer Diameter 10 mm | Withdrawn |
| 8 35 T20 | Length 35 mm | Withdrawn |
| 8 25 T20 | Length 25 mm | Withdrawn |
| 8 30 T20 | Length 30 mm | Withdrawn |
| 6 35 T20 | Outer Diameter 35 mm | Withdrawn |
| 10 30 T20 | Length 30 mm | Withdrawn |
| 10 25 T20 | Length 25 mm | Withdrawn |
| 6 25 T20 | Length 25 mm | Withdrawn |
| 6 30 T20 | Length 30 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 |
|---|---|
| K172213 | 2017-10-23 |
| K160548 | 2016-04-29 |
| K152187 | 2016-02-12 |
| K130400 | 2013-04-05 |
| K091798 | 2009-09-02 |
| K081513 | 2008-07-18 |
| K051323 | 2005-07-07 |
| K050924 | 2005-05-27 |
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.