Legion
Legion Hinge Guided Motion Tibial Insert 25MM Size 2-3 Right
7manufacturers in China registered for this device type
222catalogue numbers in this listing
2510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K081111 |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: : – |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71423344 | In distribution | ||
| 71423328 | In distribution | ||
| 71421386 | In distribution | ||
| XK000616-3 | In distribution | ||
| 71935255 | In distribution | ||
| 71422163 | In distribution | ||
| 71421902 | In distribution | ||
| 71422157 | In distribution | ||
| 71423325 | In distribution | ||
| 71421906 | In distribution | ||
| XK000613-2 | In distribution | ||
| 71422159 | In distribution | ||
| 71935249 | In distribution | ||
| XK000599-2 | In distribution | ||
| XK000710-1 | In distribution | ||
| E0017511-5 | In distribution | ||
| 71421364 | In distribution | ||
| E0017511-1 | In distribution | ||
| 71935232 | In distribution | ||
| 71421363 | In distribution | ||
| 71421905 | In distribution | ||
| 71423364 | In distribution | ||
| E0017511-7 | In distribution | ||
| 71423353 | In distribution | ||
| E0015795-1 | In distribution | ||
| E0016504-6 | In distribution | ||
| XK000701-3 | In distribution | ||
| E0017511-3 | In distribution | ||
| 71935245 | In distribution | ||
| 71422152 | In distribution | ||
| 71421389 | In distribution | ||
| XK000629-3 | In distribution | ||
| 71421366 | Size: 6 RIGHT | In distribution | |
| 71421636 | In distribution | ||
| XK000613-1 | In distribution | ||
| XK000710-2 | In distribution | ||
| XK000680-3 | In distribution | ||
| E0015227-2 | In distribution | ||
| 71422154 | In distribution | ||
| XK000726-3 | In distribution | ||
| 71422165 | In distribution | ||
| XK000644-3 | In distribution | ||
| XK000725-1 | In distribution | ||
| XK000599-1 | In distribution | ||
| 71421305 | In distribution | ||
| 71422104 | In distribution | ||
| XK000701-1 | In distribution | ||
| 71421937 | 6: 6 | In distribution | |
| 71423349 | In distribution | ||
| 71422103 | In distribution | ||
| 71421303 | In distribution | ||
| XK000681-2 | In distribution | ||
| XK000710-3 | In distribution | ||
| 71421648 | In distribution | ||
| 71421372 | 2 LEFT: 2 LEFT | In distribution | |
| 71421388 | In distribution | ||
| 71421631 | In distribution | ||
| 71421938 | In distribution | ||
| 71423351 | In distribution | ||
| E0017511-4 | In distribution | ||
| XK000663-1 | In distribution | ||
| 71423335 | In distribution | ||
| E0015795-4 | In distribution | ||
| XK000680-2 | In distribution | ||
| XK000624-1 | In distribution | ||
| 71423347 | In distribution | ||
| XK000633-1 | In distribution | ||
| XK000642-3 | In distribution | ||
| XK000726-1 | In distribution | ||
| 71935259 | In distribution | ||
| 71423338 | In distribution | ||
| 71423348 | In distribution | ||
| 71423358 | In distribution | ||
| 71935240 | In distribution | ||
| 71422101 | In distribution | ||
| 71423327 | In distribution | ||
| XK000681-3 | In distribution | ||
| 71935241 | In distribution | ||
| 71935252 | In distribution | ||
| 71421365 | In distribution | ||
| 71423337 | In distribution | ||
| XK000663-2 | In distribution | ||
| XK000701-2 | In distribution | ||
| XK000727-2 | In distribution | ||
| 71935246 | In distribution | ||
| 71421931 | In distribution | ||
| 71423341 | In distribution | ||
| 71421637 | In distribution | ||
| 71421307 | In distribution | ||
| 71423345 | In distribution | ||
| 71935231 | In distribution | ||
| 71935256 | In distribution | ||
| 71423355 | In distribution | ||
| XK000725-3 | In distribution | ||
| 71421306 | In distribution | ||
| XK000726-2 | In distribution | ||
| E0016504-1 | In distribution | ||
| 71935234 | In distribution | ||
| 71421304 | In distribution | ||
| XK000582-3 | In distribution | ||
| 71423372 | In distribution | ||
| 71423366 | In distribution | ||
| 71421933 | 6: 6 | In distribution | |
| E0016504-5 | In distribution | ||
| E0016504-4 | In distribution | ||
| 71422166 | In distribution | ||
| 71422161 | In distribution | ||
| 71421632 | In distribution | ||
| 71421374 | In distribution | ||
| 71421367 | In distribution | ||
| XK000662-1 | In distribution | ||
| XK000616-2 | In distribution | ||
| XK000642-1 | In distribution | ||
| XK000616-1 | In distribution | ||
| 71423354 | In distribution | ||
| 71422158 | In distribution | ||
| 71422106 | In distribution | ||
| XK000624-2 | In distribution | ||
| 71422107 | In distribution | ||
| 71421639 | In distribution | ||
| 71423329 | In distribution | ||
| 71423346 | In distribution | ||
| 71935233 | In distribution | ||
| XK000663-3 | In distribution | ||
| XK000629-2 | In distribution | ||
| 71935258 | In distribution | ||
| 71421385 | In distribution | ||
| 71935250 | In distribution | ||
| XK000727-3 | In distribution | ||
| 71423336 | In distribution | ||
| 71935239 | In distribution | ||
| 71421903 | In distribution | ||
| 71423333 | In distribution | ||
| E0015227-1 | In distribution | ||
| 71423359 | In distribution | ||
| 71422151 | In distribution | ||
| 71421904 | In distribution | ||
| 71423342 | In distribution | ||
| XK000613-3 | In distribution | ||
| 71422167 | In distribution | ||
| 71422168 | In distribution | ||
| E0016504-7 | In distribution | ||
| 71423371 | In distribution | ||
| E0015391-1 | In distribution | ||
| E0015391-3 | In distribution | ||
| 71422162 | In distribution | ||
| 71421377 | In distribution | ||
| 71421376 | 6 Left: 6 Left | In distribution | |
| E0016504-8 | In distribution | ||
| 71423352 | In distribution | ||
| 71421373 | In distribution | ||
| XK000644-2 | In distribution | ||
| 71421375 | In distribution | ||
| 71935238 | In distribution | ||
| E0015227-3 | In distribution | ||
| E0015391-2 | In distribution | ||
| 71935237 | In distribution | ||
| XK000636-1 | In distribution | ||
| 71421362 | 2 RIGHT: 2 RIGHT | In distribution | |
| 71423365 | In distribution | ||
| 71421934 | In distribution | ||
| XK000644-1 | In distribution | ||
| XK000624-3 | In distribution | ||
| E0015795-2 | In distribution | ||
| 71422105 | In distribution | ||
| XK000681-4 | In distribution | ||
| 71423330 | In distribution | ||
| 71935242 | In distribution | ||
| 71422155 | In distribution | ||
| 71423368 | In distribution | ||
| 71421936 | In distribution | ||
| E0015795-3 | In distribution | ||
| 71423363 | In distribution | ||
| 71423369 | In distribution | ||
| 71423332 | In distribution | ||
| XK000727-1 | In distribution | ||
| 71423326 | In distribution | ||
| 71421638 | In distribution | ||
| 71423362 | In distribution | ||
| XK000642-2 | In distribution | ||
| 71423331 | In distribution | ||
| 71423334 | In distribution | ||
| E0015227-4 | In distribution | ||
| XK000633-2 | In distribution | ||
| 71423357 | In distribution | ||
| XK000681-1 | In distribution | ||
| XK000725-2 | In distribution | ||
| XK000629-1 | In distribution | ||
| 71423343 | In distribution | ||
| 71422102 | In distribution | ||
| 71423367 | In distribution | ||
| 71421935 | In distribution | ||
| XK000582-1 | In distribution | ||
| 71421302 | In distribution | ||
| 71935243 | In distribution | ||
| E0017511-2 | In distribution | ||
| 71423339 | In distribution | ||
| 71935253 | In distribution | ||
| 71422153 | In distribution | ||
| 71935247 | In distribution | ||
| 71421932 | 2 | In distribution | |
| 71935251 | In distribution | ||
| 71935257 | In distribution | ||
| 71935235 | In distribution | ||
| E0016504-2 | In distribution | ||
| XK000599-3 | In distribution | ||
| 71421907 | In distribution | ||
| 71423361 | In distribution | ||
| 71423373 | In distribution | ||
| 71422164 | In distribution | ||
| 71423356 | In distribution | ||
| E0016504-3 | In distribution | ||
| E0015391-4 | In distribution | ||
| 71421387 | In distribution | ||
| XK000582-2 | In distribution | ||
| XK000680-1 | In distribution | ||
| 71935248 | In distribution | ||
| E0017511-6 | In distribution | ||
| XK000656-1 | In distribution | ||
| 71935244 | In distribution | ||
| 71422156 | In distribution | ||
| E0017511-8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 94 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151118 | 2015-07-28 |
| K081111 | 2008-07-23 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2018-02-01 | Class II | Process control | The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5. | 28 units | 2018-10-22 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 12 units | 2019-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 3 units | 2019-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 33 units | 2019-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 16 units | 2019-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 10 units | 2019-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2016-05-26 | Class II | Process control | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. | 97 units | 2019-08-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-06-21 | Not classified | Other | The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively. | 11,339 units were distributed | 2006-02-15 |
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.