Ortho Solutions Extremity Fixation Implants FOR Osteosysnthesis
Ortho Solutions Extremity Fixation Implants is a family of small-bone trauma and reconstruction components, including plates, screws, staples and related fixation systems. The foot-plating…
Ortho Solutions Extremity Fixation Implants is a family of small-bone trauma and reconstruction components, including plates, screws, staples and related fixation systems. The foot-plating range has locking and nonlocking plate constructs for the forefoot, midfoot and rearfoot.
Foot plates and associated screws use Ti-6Al-4V titanium alloy. The separate Memo Staple system uses superelastic Nitinol staples, opened with dedicated instruments to apply compression.
Listed Item
Foot Reconstruction System Sterilisation Tray (FRS)
Related Fixation Systems
The family also includes osteotomy, compression-screw and snap-off-screw systems, with procedure-specific instruments. Foot-plating options use 2.7 or 3.5 mm screws, and the described plates, screws and Memo Staples are supplied sterile.
22manufacturers in China registered for this device type
280catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment |
| 510(k) | K111678 |
| Record published | 2016-03-09 |
| Record revised | 2022-09-16 (version 9) |
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 |
| Packaging | Cardboard box of 2, cardboard box of 5, cardboard box of 4, cardboard box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS326130 | In distribution | |
| OS327620 | In distribution | |
| OS306222 | In distribution | |
| OS326300 | In distribution | |
| OS361602 | In distribution | |
| OS327518 | In distribution | |
| OS320049 | In distribution | |
| OS310618 | In distribution | |
| OS326002 | In distribution | |
| OS326006 | In distribution | |
| OS21070H | In distribution | |
| OS310203 | In distribution | |
| OS361612 | In distribution | |
| OS326712 | In distribution | |
| OS320028 | In distribution | |
| OS361007 | In distribution | |
| OS361246 | In distribution | |
| OS306520 | In distribution | |
| OS310516 | In distribution | |
| OS310630 | In distribution | |
| OS310826 | In distribution | |
| OS326724 | In distribution | |
| OS361006 | In distribution | |
| OS309511 | In distribution | |
| OS310632 | In distribution | |
| OS362017 | In distribution | |
| OS361008 | In distribution | |
| OS310522 | In distribution | |
| OS362015 | In distribution | |
| OS310524 | In distribution | |
| OS306512 | In distribution | |
| OS361618 | In distribution | |
| OS320038 | In distribution | |
| OS327118 | In distribution | |
| OS435000 | In distribution | |
| OS361614 | In distribution | |
| OS312025 | In distribution | |
| OS361009 | In distribution | |
| OS326726 | In distribution | |
| OS31210M | In distribution | |
| OS325001 | In distribution | |
| OS306524 | In distribution | |
| OS306328 | In distribution | |
| OS310706 | In distribution | |
| OS327614 | In distribution | |
| OS310016 | In distribution | |
| OS309517 | In distribution | |
| OS326845 | In distribution | |
| OS306212 | In distribution | |
| OS319008 | In distribution | |
| OS361235 | In distribution | |
| OS320018 | In distribution | |
| OS310530 | In distribution | |
| OS312040 | In distribution | |
| OS326710 | In distribution | |
| OS310013 | In distribution | |
| OS320210 | In distribution | |
| OS306318 | In distribution | |
| OS310636 | In distribution | |
| OS310640 | In distribution | |
| OS310010 | In distribution | |
| OS306208 | In distribution | |
| OS310204 | In distribution | |
| OS327514 | In distribution | |
| OS326810 | In distribution | |
| OS320012 | In distribution | |
| OS320212 | In distribution | |
| OS326005 | In distribution | |
| OS327608 | In distribution | |
| OS319016 | In distribution | |
| OS310014 | In distribution | |
| OS362047 | In distribution | |
| OS320034 | In distribution | |
| OS327122 | In distribution | |
| OS327204 | In distribution | |
| OS361268 | In distribution | |
| OS310526 | In distribution | |
| OS327630 | In distribution | |
| OS306320 | In distribution | |
| OS306516 | In distribution | |
| OS320214 | In distribution | |
| OS320211 | In distribution | |
| OS326003 | In distribution | |
| OS320024 | In distribution | |
| OS326722 | In distribution | |
| OS326124 | In distribution | |
| OS327524 | In distribution | |
| OS326714 | In distribution | |
| OS362525 | In distribution | |
| OS326900 | In distribution | |
| OS306508 | In distribution | |
| OS361616 | In distribution | |
| OS309514 | In distribution | |
| OS306310 | In distribution | |
| OS361668 | In distribution | |
| OS326824 | In distribution | |
| OS312030 | In distribution | |
| OS326812 | In distribution | |
| OS306220 | In distribution | |
| OS327520 | In distribution | |
| OS326720 | In distribution | |
| OS326406 | In distribution | |
| OS320114 | In distribution | |
| OS326408 | In distribution | |
| OS306210 | In distribution | |
| OS320215 | In distribution | |
| OS310620 | In distribution | |
| OS310534 | In distribution | |
| OS31210L | In distribution | |
| OS310907 | In distribution | |
| OS310206 | In distribution | |
| OS328003 | In distribution | |
| OS326302 | In distribution | |
| OS327618 | In distribution | |
| OS326112 | In distribution | |
| OS326001 | In distribution | |
| OS327624 | In distribution | |
| OS327612 | In distribution | |
| OS310017 | In distribution | |
| OS306518 | In distribution | |
| OS319010 | In distribution | |
| OS361216 | In distribution | |
| OS326308 | In distribution | |
| OS326818 | In distribution | |
| OS326516 | In distribution | |
| OS327522 | In distribution | |
| OS327616 | In distribution | |
| OS310908 | In distribution | |
| OS320050 | In distribution | |
| OS310520 | In distribution | |
| OS326820 | In distribution | |
| OS312050 | In distribution | |
| OS361213 | In distribution | |
| OS310100 | In distribution | |
| OS306326 | In distribution | |
| OS310614 | In distribution | |
| OS326304 | In distribution | |
| OS326835 | In distribution | |
| OS320036 | In distribution | |
| OS319024 | In distribution | |
| OS310626 | In distribution | |
| OS310726 | In distribution | |
| OS361215 | In distribution | |
| OS305104 | In distribution | |
| OS320020 | In distribution | |
| OS306332 | In distribution | |
| OS326822 | In distribution | |
| OS362013 | In distribution | |
| OS326750 | In distribution | |
| OS310528 | In distribution | |
| OS320112 | In distribution | |
| OS306330 | In distribution | |
| OS361010 | In distribution | |
| OS306514 | In distribution | |
| OS319012 | In distribution | |
| OS327516 | In distribution | |
| OS319056 | In distribution | |
| OS310514 | In distribution | |
| OS310012 | In distribution | |
| OS326000 | In distribution | |
| OS306526 | In distribution | |
| OS306314 | In distribution | |
| OS312060 | In distribution | |
| OS320022 | In distribution | |
| OS310624 | In distribution | |
| OS362520 | In distribution | |
| OS309512 | In distribution | |
| OS319022 | In distribution | |
| OS362515 | In distribution | |
| OS319054 | In distribution | |
| OS319028 | In distribution | |
| OS306312 | In distribution | |
| OS320111 | In distribution | |
| OS326116 | In distribution | |
| OS292100H | In distribution | |
| OS327120 | In distribution | |
| OS320016 | In distribution | |
| OS361680 | In distribution | |
| OS320032 | In distribution | |
| OS306510 | In distribution | |
| OS327622 | In distribution | |
| OS310510 | In distribution | |
| OS310628 | In distribution | |
| OS312070 | In distribution | |
| OS327530 | In distribution | |
| OS326512 | In distribution | |
| OS306322 | In distribution | |
| OS361217 | In distribution | |
| OS320030 | In distribution | |
| OS362083 | In distribution | |
| OS319020 | In distribution | |
| OS361279 | In distribution | |
| OS310532 | In distribution | |
| OS327406 | In distribution | |
| OS326716 | In distribution | |
| OS361004 | In distribution | |
| OS326718 | In distribution | |
| OS326745 | In distribution | |
| OS326816 | In distribution | |
| OS362019 | In distribution | |
| OS310015 | In distribution | |
| OS326828 | In distribution | |
| OS327626 | In distribution | |
| OS319014 | In distribution | |
| OS310011 | In distribution | |
| OS310616 | In distribution | |
| OS320014 | In distribution | |
| OS326826 | In distribution | |
| OS327404 | In distribution | |
| OS362025 | In distribution | |
| OS362526 | In distribution | |
| OS326514 | In distribution | |
| OS327405 | In distribution | |
| OS327400 | In distribution | |
| OS327628 | In distribution | |
| OS306216 | In distribution | |
| OS362081 | In distribution | |
| OS327407 | In distribution | |
| OS306316 | In distribution | |
| OS327510 | In distribution | |
| OS327526 | In distribution | |
| OS328006S | In distribution | |
| OS320058 | In distribution | |
| OS320053 | In distribution | |
| OS326120 | In distribution | |
| OS320010 | In distribution | |
| OS326414 | In distribution | |
| OS326606 | In distribution | |
| OS309515 | In distribution | |
| OS320213 | In distribution | |
| OS310710 | In distribution | |
| OS326730 | In distribution | |
| OS292080H | In distribution | |
| OS361257 | In distribution | |
| OS328002 | In distribution | |
| OS306522 | In distribution | |
| OS326728 | In distribution | |
| OS327124 | In distribution | |
| OS327508 | In distribution | |
| OS312000 | In distribution | |
| OS362069 | In distribution | |
| OS327206 | In distribution | |
| OS319018 | In distribution | |
| OS361646 | In distribution | |
| OS306214 | In distribution | |
| OS326840 | In distribution | |
| OS327610 | In distribution | |
| OS306324 | In distribution | |
| OS326814 | In distribution | |
| OS305103 | In distribution |
Showing 250 of 280 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141784 | 2014-07-23 |
| K120360 | 2012-05-29 |
| K111678 | 2012-02-07 |
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.