Smart Correction
Smart Correction is a circular external fixation system that maintains bone alignment during extremity reconstruction. At least two rings are connected by six independently adjustable…
Smart Correction is a circular external fixation system that maintains bone alignment during extremity reconstruction. At least two rings are connected by six independently adjustable telescoping struts, allowing relative ring movement along six axes.
Crossed tensioned wires and half pins anchor the frame to bone through clamps and connector elements. Stainless steel or titanium half pins are therefore anchoring components within the larger ring-and-strut system.
Listed Item
4.0/105/35mm Half Pin, Self-Drilling/Self-Tapping, QC, SS – Non-Sterile
Planning and Adjustment
A software tool uses examination findings, radiographic measurements and frame parameters to generate a correction schedule. Full and partial rings, different strut lengths and optional foot rings provide alternative frame configurations; the frame elements are supplied nonsterile with reusable assembly instruments.
17manufacturers in China registered for this device type
1,534catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Wishbone Medical Inc., United States |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K193368 |
| Record published | 2021-05-13 |
| Record revised | 2023-04-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-08-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-STID-00-WBNS | Withdrawn | |
| 31-700-16506RA-1 | Withdrawn | |
| 11-705-335151S | Withdrawn | |
| 31-700-15006GA-0 | Withdrawn | |
| 11-707-930200S | Withdrawn | |
| 50-1850-225S-WB | Withdrawn | |
| 31-700-18006PA-0 | Withdrawn | |
| 10-700-09006RA-0 | Withdrawn | |
| 11-708-310150S | Withdrawn | |
| 31-700-12038GA-0 | Withdrawn | |
| 10-700-13528UA-0 | Withdrawn | |
| 10-700-10538UA-0 | Withdrawn | |
| 10-700-10506AA-0 | Withdrawn | |
| 31-700-10538PA-0 | Withdrawn | |
| 704-330105S | Withdrawn | |
| 31-700-19538PA-0 | Withdrawn | |
| 704-425200S | Withdrawn | |
| 10-700-24038AA-0 | Withdrawn | |
| 50-1012-18A-WBNS | Withdrawn | |
| 50-1051-00-10NS | Withdrawn | |
| 704-420151S | Withdrawn | |
| 11-706-330105S | Withdrawn | |
| 50-1850-154BL-WBNS | Withdrawn | |
| 50-1153-06-WB | Withdrawn | |
| 704-325105S | Withdrawn | |
| 11-706-625150S | Withdrawn | |
| 10-700-18028GA-0 | Withdrawn | |
| 10-700-10538PA-0 | Withdrawn | |
| 50-1017-15A-WBNS | Withdrawn | |
| 10-700-07028GA-0 | Withdrawn | |
| 10-700-21038RA-0 | Withdrawn | |
| 31-700-07006AA-0 | Withdrawn | |
| 11-707-560250S | Withdrawn | |
| 50-1018-13A-WBNS | Withdrawn | |
| 11-705-530250S | Withdrawn | |
| 720-000004T | Withdrawn | |
| 11-708-320200S | Withdrawn | |
| 50-1071-16S-WBNS | Withdrawn | |
| 11-708-645200S | Withdrawn | |
| 11-700-105201T-0 | Withdrawn | |
| 50-1845-123S-WB | Withdrawn | |
| 31-700-15038BA-0 | Withdrawn | |
| 10-700-09058GA-0 | Withdrawn | |
| 11-705-430105S | Withdrawn | |
| 10-700-10506GA-0 | Withdrawn | |
| 10-700-15028UA-0 | Withdrawn | |
| 50-1860-254BL-WB | Withdrawn | |
| 50-1850-185S-WBNS | Withdrawn | |
| 10-700-08028PA-0 | Withdrawn | |
| 11-706-340151S | Withdrawn | |
| 11-708-320150S | Withdrawn | |
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| 11-706-630150S | Withdrawn | |
| 50-1056-03-WB | Withdrawn | |
| 11-707-930150S | Withdrawn | |
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| 50-1850-205BL-WBNS | Withdrawn | |
| 10-700-16506UA-0 | Withdrawn | |
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| 11-706-410105S | Withdrawn | |
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| 10-700-21058GA-0 | Withdrawn | |
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| 11-706-640150S | Withdrawn | |
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| 00-STID-00-WB | Withdrawn | |
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| 11-708-630250S | Withdrawn | |
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| 50-1860-223S-WB | Withdrawn | |
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| 31-700-07006BA-0 | Withdrawn | |
| 50-1850-185BL-WBNS | Withdrawn | |
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| 10-700-07006GA-0 | Withdrawn | |
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| 31-700-16538PA-0 | Withdrawn | |
| 10-700-15058BA-0 | Withdrawn | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Smith & Nephew, Inc. | 204 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231461 | 2023-06-16 |
| K221366 | 2022-06-06 |
| K193368 | 2020-09-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Wishbone Medical Inc. | 510(k) number | 2023-01-04 | Class II | Process design | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction. | 195 |
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.