LCP
3.5MM LCP Postlat Dist Humerus PL-LAT SUPPORT/5H/RT/90MM-STE
17manufacturers in China registered for this device type
355catalogue numbers in this listing
1510(k) clearance
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 | Synthes Gmbh, Switzerland |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K041911 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 10) |
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 |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.001.320 | In distribution | |
| 241.440S | In distribution | |
| 236.513S | In distribution | |
| 241.288 | In distribution | |
| 436.512 | In distribution | |
| 241.274S | In distribution | |
| 441.454 | In distribution | |
| 423.601 | In distribution | |
| 241.283 | In distribution | |
| 441.051 | In distribution | |
| 241.444S | In distribution | |
| 241.971 | In distribution | |
| 236.507S | In distribution | |
| 441.451 | In distribution | |
| 245.221 | In distribution | |
| 241.951 | In distribution | |
| 241.131 | In distribution | |
| 241.263 | In distribution | |
| 242.462 | In distribution | |
| 436.511S | In distribution | |
| 441.181 | In distribution | |
| 241.457 | In distribution | |
| 441.273 | In distribution | |
| 241.272S | In distribution | |
| 241.304 | In distribution | |
| 441.453 | In distribution | |
| 223.591 | In distribution | |
| 241.279S | In distribution | |
| 241.285S | In distribution | |
| 241.061 | In distribution | |
| 441.274 | In distribution | |
| 423.651 | In distribution | |
| 236.502 | In distribution | |
| 423.611 | In distribution | |
| 441.131 | In distribution | |
| 245.051 | In distribution | |
| 441.151 | In distribution | |
| 426.561 | In distribution | |
| 245.141 | In distribution | |
| 441.288 | In distribution | |
| 441.276 | In distribution | |
| 236.508 | In distribution | |
| 445.071 | In distribution | |
| 226.672S | In distribution | |
| 241.266 | In distribution | |
| 241.282 | In distribution | |
| 223.631 | In distribution | |
| 02.001.322 | In distribution | |
| 441.301 | In distribution | |
| 245.181 | In distribution | |
| 441.277 | In distribution | |
| 241.452 | In distribution | |
| 441.445 | In distribution | |
| 223.531 | In distribution | |
| 440.141 | In distribution | |
| 241.265 | In distribution | |
| 436.508 | In distribution | |
| 445.041 | In distribution | |
| 436.502 | In distribution | |
| 241.448 | In distribution | |
| 02.001.304 | In distribution | |
| 426.661 | In distribution | |
| 241.267S | In distribution | |
| 241.453 | In distribution | |
| 241.267 | In distribution | |
| 436.505S | In distribution | |
| 241.305S | In distribution | |
| 241.300 | In distribution | |
| 241.081 | In distribution | |
| 241.443S | In distribution | |
| 241.456 | In distribution | |
| 236.510 | In distribution | |
| 245.041 | In distribution | |
| 441.951 | In distribution | |
| 245.201 | In distribution | |
| 441.447 | In distribution | |
| 245.131 | In distribution | |
| 445.121 | In distribution | |
| 241.288S | In distribution | |
| 441.287 | In distribution | |
| 424.561 | In distribution | |
| 241.141 | In distribution | |
| 223.601 | In distribution | |
| 241.441S | In distribution | |
| 241.451S | In distribution | |
| 426.622S | In distribution | |
| 445.091 | In distribution | |
| 441.450 | In distribution | |
| 441.455 | In distribution | |
| 224.591 | In distribution | |
| 241.283S | In distribution | |
| 02.001.328S | In distribution | |
| 441.457 | In distribution | |
| 241.276S | In distribution | |
| 441.441 | In distribution | |
| 441.971 | In distribution | |
| 241.453S | In distribution | |
| 02.001.312S | In distribution | |
| 240.181 | In distribution | |
| 02.001.310S | In distribution | |
| 441.282 | In distribution | |
| 236.502S | In distribution | |
| 245.121 | In distribution | |
| 423.531 | In distribution | |
| 441.268 | In distribution | |
| 441.132 | In distribution | |
| 441.440 | In distribution | |
| 236.513 | In distribution | |
| 436.506 | In distribution | |
| 241.301 | In distribution | |
| 436.505 | In distribution | |
| 436.512S | In distribution | |
| 436.509S | In distribution | |
| 241.441 | In distribution | |
| 423.641 | In distribution | |
| 426.672S | In distribution | |
| 241.284S | In distribution | |
| 02.001.324 | In distribution | |
| 236.511 | In distribution | |
| 440.181 | In distribution | |
| 236.512 | In distribution | |
| 241.445S | In distribution | |
| 241.446S | In distribution | |
| 436.503 | In distribution | |
| 445.131 | In distribution | |
| 241.443 | In distribution | |
| 441.446 | In distribution | |
| 241.456S | In distribution | |
| 241.277 | In distribution | |
| 441.061 | In distribution | |
| 241.302 | In distribution | |
| 02.001.302 | In distribution | |
| 02.001.302S | In distribution | |
| 241.182 | In distribution | |
| 441.284 | In distribution | |
| 245.081 | In distribution | |
| 241.265S | In distribution | |
| 241.303 | In distribution | |
| 423.541 | In distribution | |
| 236.504 | In distribution | |
| 441.266 | In distribution | |
| 241.442 | In distribution | |
| 02.001.306S | In distribution | |
| 241.161 | In distribution | |
| 241.142 | In distribution | |
| 241.931 | In distribution | |
| 241.171 | In distribution | |
| 423.661 | In distribution | |
| 236.506 | In distribution | |
| 241.449S | In distribution | |
| 241.454 | In distribution | |
| 236.507 | In distribution | |
| 426.722S | In distribution | |
| 426.721 | In distribution | |
| 441.262 | In distribution | |
| 423.551 | In distribution | |
| 241.449 | In distribution | |
| 441.171 | In distribution | |
| 241.275 | In distribution | |
| 241.303S | In distribution | |
| 241.289S | In distribution | |
| 241.304S | In distribution | |
| 241.031 | In distribution | |
| 241.277S | In distribution | |
| 441.442 | In distribution | |
| 241.272 | In distribution | |
| 236.505S | In distribution | |
| 441.302 | In distribution | |
| 245.071 | In distribution | |
| 436.504S | In distribution | |
| 441.071 | In distribution | |
| 441.141 | In distribution | |
| 426.681 | In distribution | |
| 236.509 | In distribution | |
| 436.504 | In distribution | |
| 426.662S | In distribution | |
| 441.275 | In distribution | |
| 445.061 | In distribution | |
| 441.031 | In distribution | |
| 241.450 | In distribution | |
| 236.511S | In distribution | |
| 441.182 | In distribution | |
| 02.001.300 | In distribution | |
| 241.448S | In distribution | |
| 02.001.326 | In distribution | |
| 02.001.328 | In distribution | |
| 241.276 | In distribution | |
| 445.101 | In distribution | |
| 241.172 | In distribution | |
| 241.447S | In distribution | |
| 423.631 | In distribution | |
| 423.581 | In distribution | |
| 436.511 | In distribution | |
| 441.300 | In distribution | |
| 226.571 | In distribution | |
| 02.001.322S | In distribution | |
| 241.452S | In distribution | |
| 236.505 | In distribution | |
| 236.510S | In distribution | |
| 241.440 | In distribution | |
| 240.141 | In distribution | |
| 240.161 | In distribution | |
| 423.671 | In distribution | |
| 241.287 | In distribution | |
| 436.510 | In distribution | |
| 445.181 | In distribution | |
| 441.444 | In distribution | |
| 445.081 | In distribution | |
| 426.701 | In distribution | |
| 445.221 | In distribution | |
| 241.282S | In distribution | |
| 441.283 | In distribution | |
| 236.508S | In distribution | |
| 441.449 | In distribution | |
| 236.504S | In distribution | |
| 426.591 | In distribution | |
| 226.701 | In distribution | |
| 241.446 | In distribution | |
| 241.262S | In distribution | |
| 441.931 | In distribution | |
| 423.621 | In distribution | |
| 02.001.320S | In distribution | |
| 445.111 | In distribution | |
| 241.274 | In distribution | |
| 241.454S | In distribution | |
| 223.581 | In distribution | |
| 224.531 | In distribution | |
| 241.275S | In distribution | |
| 236.503S | In distribution | |
| 241.071 | In distribution | |
| 241.450S | In distribution | |
| 241.286 | In distribution | |
| 441.263 | In distribution | |
| 223.691 | In distribution | |
| 226.681 | In distribution | |
| 441.269 | In distribution | |
| 241.287S | In distribution | |
| 241.302S | In distribution | |
| 426.641 | In distribution | |
| 426.621 | In distribution | |
| 436.513S | In distribution | |
| 441.142 | In distribution | |
| 441.267 | In distribution | |
| 241.289 | In distribution | |
| 423.691 | In distribution | |
| 02.001.308 | In distribution | |
| 423.681 | In distribution | |
| 223.611 | In distribution | |
| 241.278 | In distribution | |
| 440.161 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
|---|---|
| K122455 | 2013-04-11 |
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 |
|---|---|---|---|---|---|---|---|
| Synthes Gmbh | 510(k) number | 2015-05-13 | Class II | Employee error | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. | 54 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Process control | The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number. | 13 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-03-08 | Class II | Labeling mix-ups | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). | 2 | 2015-05-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
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.