VHS Vari-Angle HIP Screw
83 catalogue numbers from 16-235150, listed by Biomet Orthopedics, United States, under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
83catalogue numbers in this listing
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 | Biomet Orthopedics, 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 |
| 510(k) | K011603 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 7) |
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 |
| Distribution end date | 2022-07-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-235150 | 4.5MM Ø 50MM LENGTH | In distribution |
| 16-235138 | 4.5MM Ø 38MM LENGTH | In distribution |
| 16-235160 | 4.5MM Ø 60MM LENGTH | In distribution |
| 16-235328 | 3.5MM Ø 28MM LENGTH | In distribution |
| 16-235132 | 4.5MM Ø 32MM LENGTH | In distribution |
| 16-235245 | 6.5MM Ø 45MM LENGTH 16MM THREAD | In distribution |
| 16-235324 | 3.5MM Ø 24MM LENGTH | In distribution |
| 16-235120 | 4.5MM Ø 20MM LENGTH | In distribution |
| 16-235260 | 6.5MM Ø 60MM LENGTH 16MM THREAD | In distribution |
| 16-235345 | 3.5MM Ø 45MM LENGTH | In distribution |
| 16-235265 | 6.5MM Ø 65MM LENGTH 16MM THREAD | In distribution |
| 16-235340 | 3.5MM Ø 40MM LENGTH | In distribution |
| 16-235140 | 4.5MM Ø 40MM LENGTH | In distribution |
| 16-235128 | 4.5MM Ø 28MM LENGTH | In distribution |
| 16-235314 | 3.5MM Ø 14MM LENGTH | In distribution |
| 16-235326 | 3.5MM Ø 26MM LENGTH | In distribution |
| 16-235136 | 4.5MM Ø 36MM LENGTH | In distribution |
| 16-235152 | 4.5MM Ø 52MM LENGTH | In distribution |
| 16-235255 | 6.5MM Ø 55MM LENGTH 16MM THREAD | In distribution |
| 16-235332 | 3.5MM Ø 32MM LENGTH | In distribution |
| 16-235280 | 6.5MM Ø 80MM LENGTH 16MM THREAD | In distribution |
| 16-235320 | 3.5MM Ø 20MM LENGTH | In distribution |
| 16-235250 | 6.5MM Ø 50MM LENGTH 16MM THREAD | In distribution |
| 16-235348 | 3.5MM Ø 48MM LENGTH | In distribution |
| 16-235154 | 4.5MM Ø 54MM LENGTH | In distribution |
| 16-235336 | 3.5MM Ø 36MM LENGTH | In distribution |
| 16-235334 | 3.5MM Ø 34MM LENGTH | In distribution |
| 16-235142 | 4.5MM Ø 42MM LENGTH | In distribution |
| 16-235130 | 4.5MM Ø 30MM LENGTH | In distribution |
| 16-235342 | 3.5MM Ø 42MM LENGTH | In distribution |
| 16-235134 | 4.5MM Ø 34MM LENGTH | In distribution |
| 16-235146 | 4.5MM Ø 46MM LENGTH | In distribution |
| 16-235338 | 3.5MM Ø 38MM LENGTH | In distribution |
| 16-235330 | 3.5MM Ø 30MM LENGTH | In distribution |
| 16-235270 | 6.5MM Ø 70MM LENGTH 16MM THREAD | In distribution |
| 16-235322 | 3.5MM Ø 22MM LENGTH | In distribution |
| 16-235124 | 4.5MM Ø 24MM LENGTH | In distribution |
| 16-235275 | 6.5MM Ø 75MM LENGTH 16MM THREAD | In distribution |
| 16-235346 | 3.5MM Ø 46MM LENGTH | In distribution |
| 16-235316 | 3.5MM Ø 16MM LENGTH | In distribution |
| 16-235148 | 4.5MM Ø 48MM LENGTH | In distribution |
| 16-235344 | 3.5MM Ø 44MM LENGTH | In distribution |
| 16-235122 | 4.5MM Ø 22MM LENGTH | In distribution |
| 16-235235 | 6.5MM Ø 35MM LENGTH 16MM THREAD | In distribution |
| 16-235126 | 4.5MM Ø 26MM LENGTH | In distribution |
| 16-235240 | 6.5MM Ø 40MM LENGTH 16MM THREAD | In distribution |
| 16-235350 | 3.5MM Ø 50MM LENGTH | In distribution |
| 16-235158 | 4.5MM Ø 58MM LENGTH | In distribution |
| 16-235156 | 4.5MM Ø 56MM LENGTH | In distribution |
| 16-235318 | 3.5MM Ø 18MM LENGTH | In distribution |
| 16-235144 | 4.5MM Ø 44MM LENGTH | In distribution |
| 200185 | 12.7MM Ø 85MM LENGTH | Withdrawn |
| 200304 | 88MM LENGTH | Withdrawn |
| 200390 | 15MM Ø 90MM LENGTH | Withdrawn |
| 200110 | 184MM LENGTH | Withdrawn |
| 200000 | 15MM Ø 100MM LENGTH | Withdrawn |
| 200215 | 12.7MM Ø 115MM LENGTH | Withdrawn |
| 200104 | 88MM LENGTH | Withdrawn |
| 200200 | 12.7MM Ø 100MM LENGTH | Withdrawn |
| 200106 | 120MM LENGTH | Withdrawn |
| 200112T | 216MM LENGTH | Withdrawn |
| 200225 | 12.7MM Ø 125MM LENGTH | Withdrawn |
| 200150 | 12.7MM Ø 50MM LENGTH | Withdrawn |
| 200230 | 12.7MM Ø 130MM LENGTH | Withdrawn |
| 200190 | 12.7MM Ø 90MM LENGTH | Withdrawn |
| 201102 | 56MM LENGTH | Withdrawn |
| 200108 | 152MM LENGTH | Withdrawn |
| 200395 | 15MM Ø 95MM LENGTH | Withdrawn |
| 200114T | 248MM LENGTH | Withdrawn |
| 200155 | 12.7MM Ø 55MM LENGTH | Withdrawn |
| 200175 | 12.7MM Ø 75MM LENGTH | Withdrawn |
| 200170 | 12.7MM Ø 70MM LENGTH | Withdrawn |
| 200180 | 12.7MM Ø 80MM LENGTH | Withdrawn |
| 200165 | 12.7MM Ø 65MM LENGTH | Withdrawn |
| 200385 | 15MM Ø 85MM LENGTH | Withdrawn |
| 200205 | 12.7MM Ø 105MM LENGTH | Withdrawn |
| 200380 | 15MM Ø 80MM LENGTH | Withdrawn |
| 200195 | 12.7MM Ø 95MM LENGTH | Withdrawn |
| 200306 | 120MM LENGTH | Withdrawn |
| 200160 | 12.7MM Ø 60MM LENGTH | Withdrawn |
| 200210 | 12.7MM Ø 110MM LENGTH | Withdrawn |
| 200220 | 12.7MM Ø 120MM LENGTH | Withdrawn |
| 200375 | 15MM Ø 75MM LENGTH | 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
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2016-04-01 | Class II | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it ma | 2017-05-23 | |
| EBI, LLC | 510(k) number | 2006-09-06 | Not classified | Other | VHS Plate and lag screw components did not assemble correctly intraoperatively. | 1117 in distributor inventory, 205 implanted, 1372 in manufa | 2007-02-21 |
| EBI, LLC | 510(k) number | 2006-09-06 | Not classified | Other | VHS Plate and lag screw components did not assemble correctly intraoperatively. | 363 in distributor inventory, 205 implanted, 352 plates in m | 2007-02-21 |
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.