Integra® External Fixation System
The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large…
The strut is an adjustable component designed to facilitate building and maintaining frames, from initial surgery to follow-up care. This strut features an unlocked mode, where large adjustments may be made to the component’s vertical translation. It also features two distal ends which are designed to enable construction of frames with offset rings or different diameter rings. The tightened mode allows for fine adjustments in vertical translation; this enables surgeons to conveniently apply compression and distraction to the frame, both intra-operatively and post-operatively. The fully locked mode restricts translation and angular movement creating a rigid construct.
17manufacturers in China registered for this device type
77catalogue numbers in this listing
1510(k) clearance
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 | Ascension Orthopedics, 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 | Manufacturer |
| 510(k) | K140463 |
| Record published | 2017-10-09 |
| Record revised | 2023-01-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12224251 | 10 mm hex x 14 mm L | In distribution |
| 12220037 | 200 mm L; 50 mm thread L | In distribution |
| 12224235 | 2.53 in L x.586 in W | In distribution |
| 12224120 | 180 mm inner dia | In distribution |
| 12224104 | 160 mm inner dia | In distribution |
| 12224132 | 200 mm inner dia | In distribution |
| 12224229 | 2.491 in L; 1.496 in inner L | In distribution |
| 12224103 | 160 mm inner dia | In distribution |
| 12220038 | 200 mm L; 30 mm thread L | In distribution |
| 12224243 | 115 mm L | In distribution |
| 12224219 | 1.14 in L x.626 in full thread L | In distribution |
| 12224102 | 160 mm inner dia | In distribution |
| 12224228 | 2.099 in L; 1.096 in inner L | In distribution |
| 12224209 | .469 in outer dia x.118 in depth | In distribution |
| 12224211 | 40 mm L | In distribution |
| 12224207 | .50 in H | In distribution |
| 12224223 | 1.223 in H | In distribution |
| 12220040 | 200 mm L; 50 mm thread L | In distribution |
| 12224110 | 140 mm inner dia | In distribution |
| 12224123 | 180 mm inner dia | In distribution |
| 12224216 | .59 in H x.394 in top dia | In distribution |
| 12224250 | 10mm hex x 10 mm L | In distribution |
| 12224255 | 10 mm hex x 5 mm H | In distribution |
| 12224101 | 160 mm inner dia | In distribution |
| 12220021 | 15.75 in L x.079 in dia | In distribution |
| 12224212 | 60 mm L | In distribution |
| 12220023 | 15.75 in L x.079 in dia | In distribution |
| 12224141 | 220 mm inner dia | In distribution |
| 12224121 | 180 mm inner dia | In distribution |
| 12224245 | 200 mm L | In distribution |
| 12220024 | 20.87 in L x.079 in dia | In distribution |
| 12220035 | 200 mm L; 30 mm thread L | In distribution |
| 12224131 | 200 mm inner dia | In distribution |
| 12220033 | 200mm L; 30 mm thread L | In distribution |
| 12224225 | 2.226 in H | In distribution |
| 12225221 | 1.28 in L | In distribution |
| 12224214 | .87 in major dia x.560 in H | In distribution |
| 12224100 | 160 mm inner dia | In distribution |
| 12224241 | 60 mm L | In distribution |
| 12224252 | 10 mm hex x 18 mm L | In distribution |
| 12224112 | 140 mm inner dia | In distribution |
| 12224218 | .93 in L x.410 in full thread L | In distribution |
| 12224220 | 1.08 in L x.90 in W x.354 in H | In distribution |
| 12225010 | .97 in L x.846 in W;.394 in taper | In distribution |
| 12224240 | 20 mm L | In distribution |
| 12224122 | 180 mm inner dia | In distribution |
| 12224217 | 2.72 in L | In distribution |
| 12220032 | 200 mm L; 20 mm thread L | In distribution |
| 12225400 | 10.71 in L x 10.11 in W | In distribution |
| 12220034 | 200 mm L; 40 mm thread L | In distribution |
| 12224222 | .722 in H | In distribution |
| 12224114 | 140 mm inner dia | In distribution |
| 12224111 | 140 mm inner dia | In distribution |
| 12224244 | 165 mm L | In distribution |
| 12220025 | .394 in dia x.039 in H | In distribution |
| 12224143 | 220 mm inner dia | In distribution |
| 12224133 | 200 mm inner dia | In distribution |
| 12224210 | 20 mm L | In distribution |
| 12224124 | 180 mm inner dia | In distribution |
| 12224113 | 140 mm inner dia | In distribution |
| 12224202 | 4 mm H | In distribution |
| 12224201 | 2mm H | In distribution |
| 12225032 | 160mm/180mm | In distribution |
| 12224208 | .472 in outer dia x.118 in depth | In distribution |
| 12220036 | 200 mm L; 40 mm thread L | In distribution |
| 12224242 | 85 mm L | In distribution |
| 12220039 | 200 mm L; 40 mm thread L | In distribution |
| 12225030 | 140mm/160mm | In distribution |
| 12224224 | 1.725 in H | In distribution |
| 12225223 | 1.116 in L x 1.107 in W | Withdrawn |
| XFIX2RODSIMP | Withdrawn | |
| XFIX4RCKRIMP | Withdrawn | |
| XFIX1BOLTIMP | Withdrawn | |
| 12225200 | Short: 95 – 140mm L | Withdrawn |
| 12225210 | Medium: 140 – 180mm L | Withdrawn |
| XFIX5RINGIMP | Withdrawn | |
| 12225220 | Long: 180 – 230mm L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| 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 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160830 | 2016-07-06 |
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 |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2016-07-20 | Class II | Device Design | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. | 495 units | 2016-12-16 |
| Integra Lifesciences Corporation | 510(k) number | 2016-07-20 | Class II | Device Design | Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site. | 111 units | 2016-12-16 |
| Integra Lifesciences Corporation | 510(k) number | 2016-07-01 | Class II | Device Design | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold. | 27 units | 2016-12-16 |
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.