Axiom®
AXIOM® REVERSE ADAPTIVE TIBIAL INSERT X-LARGE 80mm 20mm THICK
21manufacturers in China registered for this device type
275catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (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 |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Microport Orthopedics Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K894334 |
| Record published | 2015-10-22 |
| Record revised | 2021-02-05 (version 4) |
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, manufacturing date |
| Sizes | Height 5 to 30 mm; width 55 to 85 mm; outer diameter 29 to 85 mm; length 40 to 180 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1414750500 | Height 5 mm | In distribution |
| 1421852500 | Height 25 mm | In distribution |
| 1413751000 | Height 10 mm | In distribution |
| 1421851000 | Height 10 mm | In distribution |
| 1282701200 | Height 12 mm | In distribution |
| 1280RT7500 | Width 75 mm | In distribution |
| 1290651700 | Height 17 mm | In distribution |
| 1290602000 | Height 20 mm | In distribution |
| 1285410000 | Outer Diameter 41 mm | In distribution |
| 1274006500 | Width 65 mm | In distribution |
| 1310801400 | Height 14 mm | In distribution |
| 1255651000 | Height 10 mm | In distribution |
| 1421701000 | Height 10 mm | In distribution |
| 1279007000 | Width 70 mm | In distribution |
| 1285320000 | Outer Diameter 32 mm | In distribution |
| 1410LT8500 | Outer Diameter 85 mm | In distribution |
| 1310651400 | Height 14 mm | In distribution |
| 1282651400 | Height 14 mm | In distribution |
| 1283100000 | In distribution | |
| 1421802000 | Height 20 mm | In distribution |
| 1290801000 | Height 10 mm | In distribution |
| 1413651000 | Height 10 mm | In distribution |
| 1280RT7000 | Width 70 mm | In distribution |
| 1282651000 | Height 10 mm | In distribution |
| 1310852000 | Height 20 mm | In distribution |
| 1413600500 | Height 5 mm | In distribution |
| 1421652000 | Height 20 mm | In distribution |
| 1279007500 | Width 75 mm | In distribution |
| 1421703000 | Height 30 mm | In distribution |
| 1310651700 | Height 17 mm | In distribution |
| 1281RT5500 | Width 55 mm | In distribution |
| 1282801200 | Height 12 mm | In distribution |
| 1410RT7000 | Outer Diameter 70 mm | In distribution |
| 1290653000 | Height 30 mm | In distribution |
| 1414700500 | Height 5 mm | In distribution |
| 1576007000 | Width 70 mm | In distribution |
| 1277007000 | Width 70 mm | In distribution |
| 1283801000 | Height 10 mm | In distribution |
| 1421801700 | Height 17 mm | In distribution |
| 1255801400 | Height 14 mm | In distribution |
| 1279149000 | Length 90 mm | In distribution |
| 1331751700 | Height 17 mm | In distribution |
| 1414850500 | Height 5 mm | In distribution |
| 1274008500 | Width 85 mm | In distribution |
| 1279189000 | Length 90 mm | In distribution |
| 1310701400 | Height 14 mm | In distribution |
| 1310701000 | Height 10 mm | In distribution |
| 1421802500 | Height 25 mm | In distribution |
| 1280RT6500 | Width 65 mm | In distribution |
| 1310702000 | Height 20 mm | In distribution |
| 1290652000 | Height 20 mm | In distribution |
| 1280LT7500 | Width 75 mm | In distribution |
| 1282801000 | Height 10 mm | In distribution |
| 1421651000 | Height 10 mm | In distribution |
| 1290651000 | Height 10 mm | In distribution |
| 1289802000 | Height 20 mm | In distribution |
| 1310852500 | Height 25 mm | In distribution |
| 1290751700 | Height 17 mm | In distribution |
| 1289702000 | Height 20 mm | In distribution |
| 1289751400 | Height 14 mm | In distribution |
| 1279121800 | Length 180 mm | In distribution |
| 1283650500 | Height 5 mm | In distribution |
| 1413700500 | Height 5 mm | In distribution |
| 1281RT6500 | Width 65 mm | In distribution |
| 1421752500 | Height 25 mm | In distribution |
| 1279008500 | Width 85 mm | In distribution |
| 1255651200 | Height 12 mm | In distribution |
| 1279161800 | Length 180 mm | In distribution |
| 1414651000 | Height 10 mm | In distribution |
| 1280LT6500 | Width 65 mm | In distribution |
| 1310752000 | Height 20 mm | In distribution |
| 1279169000 | Length 90 mm | In distribution |
| 1310802000 | Height 20 mm | In distribution |
| 1282701000 | Height 10 mm | In distribution |
| 1421751000 | Height 10 mm | In distribution |
| 1414851000 | Height 10 mm | In distribution |
| 1255651700 | Height 17 mm | In distribution |
| 1290651200 | Height 12 mm | In distribution |
| 1255701700 | Height 17 mm | In distribution |
| 1421701700 | Height 17 mm | In distribution |
| 1281LT8500 | Width 85 mm | In distribution |
| 1285380000 | Outer Diameter 38 mm | In distribution |
| 1290801200 | Height 12 mm | In distribution |
| 1578004000 | Length 40 mm | In distribution |
| 1413601000 | Height 10 mm | In distribution |
| 1290702000 | Height 20 mm | In distribution |
| 1290703000 | Height 30 mm | In distribution |
| 1421601700 | Height 17 mm | In distribution |
| 1255801000 | Height 10 mm | In distribution |
| 1270005500 | Width 55 mm | In distribution |
| 1289651400 | Height 14 mm | In distribution |
| 1255701000 | Height 10 mm | In distribution |
| 1310751200 | Height 12 mm | In distribution |
| 1414601000 | Height 10 mm | In distribution |
| 1255751100 | Height 11 mm | In distribution |
| 1421651200 | Height 12 mm | In distribution |
| 1289752000 | Height 20 mm | In distribution |
| 1421652500 | Height 25 mm | In distribution |
| 1290651400 | Height 14 mm | In distribution |
| 1421853000 | Height 30 mm | In distribution |
| 1280LT6000 | Width 60 mm | In distribution |
| 1310751400 | Height 14 mm | In distribution |
| 1255801200 | Height 12 mm | In distribution |
| 1414801000 | Height 10 mm | In distribution |
| 1279141800 | Length 180 mm | In distribution |
| 1281RT7500 | Width 75 mm | In distribution |
| 1413750500 | Height 5 mm | In distribution |
| 1290753000 | Height 30 mm | In distribution |
| 1421851700 | Height 17 mm | In distribution |
| 1255751700 | Height 17 mm | In distribution |
| 1290853000 | Height 30 mm | In distribution |
| 1282701400 | Height 14 mm | In distribution |
| 1255751400 | Height 14 mm | In distribution |
| 1279006500 | Width 65 mm | In distribution |
| 1290552000 | Height 20 mm | In distribution |
| 1289801000 | Height 10 mm | In distribution |
| 1255651100 | Height 11 mm | In distribution |
| 1413650500 | Height 5 mm | In distribution |
| 1414751000 | Height 10 mm | In distribution |
| 1293290000 | Outer Diameter 29 mm | In distribution |
| 1331851400 | Outer Diameter 85 mm | In distribution |
| 1310652000 | Height 20 mm | In distribution |
| 1421801400 | Height 14 mm | In distribution |
| 1285290000 | Outer Diameter 29 mm | In distribution |
| 1290851400 | Height 14 mm | In distribution |
| 1310701700 | Height 17 mm | In distribution |
| 1310801200 | Height 12 mm | In distribution |
| 1421601200 | Height 12 mm | In distribution |
| 1277008000 | Width 80 mm | In distribution |
| 1409LT6500 | Outer Diameter 65 mm | In distribution |
| 1281LT8000 | Width 80 mm | In distribution |
| 1282701700 | Height 17 mm | In distribution |
| 1270008500 | Width 85 mm | In distribution |
| 1290751000 | Height 10 mm | In distribution |
| 1270006000 | Width 60 mm | In distribution |
| 1414701000 | Height 10 mm | In distribution |
| 1310651000 | Height 10 mm | In distribution |
| 1576008000 | Width 80 mm | In distribution |
| 1310750800 | Height 8 mm | In distribution |
| 1421702000 | Height 20 mm | In distribution |
| 1421702500 | Height 25 mm | In distribution |
| 1410RT6000 | Outer Diameter 60 mm | In distribution |
| 1310751700 | Height 17 mm | In distribution |
| 1290852500 | Height 25 mm | In distribution |
| 1293380000 | Outer Diameter 38 mm | In distribution |
| 1280RT6000 | Width 60 mm | In distribution |
| 1255751200 | Height 12 mm | In distribution |
| 1576006500 | Width 65 mm | In distribution |
| 1410RT8500 | Outer Diameter 85 mm | In distribution |
| 1290801700 | Height 17 mm | In distribution |
| 1274007000 | Width 70 mm | In distribution |
| 1290701200 | Height 12 mm | In distribution |
| 1283701000 | Height 10 mm | In distribution |
| 1421751200 | Height 12 mm | In distribution |
| 1270007500 | Width 75 mm | In distribution |
| 1310801000 | Height 10 mm | In distribution |
| 1290752000 | Height 20 mm | In distribution |
| 1280LT8500 | Width 85 mm | In distribution |
| 1413850500 | Height 5 mm | In distribution |
| 1281LT5500 | Width 55 mm | In distribution |
| 1290701000 | Height 10 mm | In distribution |
| 1270008000 | Width 80 mm | In distribution |
| 1289652000 | Height 20 mm | In distribution |
| 1421753000 | Height 30 mm | In distribution |
| 1421851400 | Height 14 mm | In distribution |
| 1289701200 | Height 12 mm | In distribution |
| 1290702500 | Height 25 mm | In distribution |
| 1290851200 | Height 12 mm | In distribution |
| 1293320000 | Outer Diameter 32 mm | In distribution |
| 1283651000 | Height 10 mm | In distribution |
| 1281RT8500 | Width 85 mm | In distribution |
| 1421653000 | Height 30 mm | In distribution |
| 1293440000 | Outer Diameter 44 mm | In distribution |
| 1290602500 | Height 25 mm | In distribution |
| 1421651400 | Height 14 mm | In distribution |
| 1421851200 | Height 12 mm | In distribution |
| 1290802000 | Height 20 mm | In distribution |
| 1421651700 | Height 17 mm | In distribution |
| 1283700500 | Height 5 mm | In distribution |
| 1410LT7000 | Outer Diameter 70 mm | In distribution |
| 1280RT8500 | Width 85 mm | In distribution |
| 1310703000 | Height 30 mm | In distribution |
| 1289701000 | Height 10 mm | In distribution |
| 1290751200 | Height 12 mm | In distribution |
| 1414800500 | Height 5 mm | In distribution |
| 1281LT6500 | Width 65 mm | In distribution |
| 1289751700 | Height 17 mm | In distribution |
| 1290701700 | Height 17 mm | In distribution |
| 1285350000 | Outer Diameter 35 mm | In distribution |
| 1410RT6500 | Outer Diameter 65 mm | In distribution |
| 1282751200 | Height 12 mm | In distribution |
| 1255701400 | Height 14 mm | In distribution |
| 1281RT8000 | Width 80 mm | In distribution |
| 1310851200 | Height 12 mm | In distribution |
| 1421751700 | Height 17 mm | In distribution |
| 1280LT7000 | Width 70 mm | In distribution |
| 1289651700 | Height 17 mm | In distribution |
| 1290552500 | Height 25 mm | In distribution |
| 1289701700 | Height 17 mm | In distribution |
| 1281LT7500 | Width 75 mm | In distribution |
| 1279109000 | Length 90 mm | In distribution |
| 1421701200 | Height 12 mm | In distribution |
| 1414600500 | Height 5 mm | In distribution |
| 1274008000 | Width 80 mm | In distribution |
| 1270007000 | Width 70 mm | In distribution |
| 1290751400 | Height 14 mm | In distribution |
| 1281LT6000 | Width 60 mm | In distribution |
| 1310851400 | Height 14 mm | In distribution |
| 1290553000 | Height 30 mm | In distribution |
| 1270006500 | Width 65 mm | In distribution |
| 1280RT5500 | Width 55 mm | In distribution |
| 1290701400 | Height 14 mm | In distribution |
| 1289651200 | Height 12 mm | In distribution |
| 1290752500 | Height 25 mm | In distribution |
| 1282751000 | Height 10 mm | In distribution |
| 1290852000 | Height 20 mm | In distribution |
| 1277006500 | Width 65 mm | In distribution |
| 1289801700 | Height 17 mm | In distribution |
| 1421751400 | Height 14 mm | In distribution |
| 1289751200 | Height 12 mm | In distribution |
| 1421602500 | Height 25 mm | In distribution |
| 1274007500 | Width 75 mm | In distribution |
| 1255801700 | Height 17 mm | In distribution |
| 1277007500 | Width 75 mm | In distribution |
| 1283751500 | Height 15 mm | In distribution |
| 1413801000 | Height 10 mm | In distribution |
| 1289751000 | Height 10 mm | In distribution |
| 1293410000 | Outer Diameter 41 mm | In distribution |
| 1279181800 | Length 180 mm | In distribution |
| 1421801200 | Height 12 mm | In distribution |
| 1283751000 | Height 10 mm | In distribution |
| 1421852000 | Height 20 mm | In distribution |
| 1279129000 | Length 90 mm | In distribution |
| 1289701400 | Height 14 mm | In distribution |
| 1576008500 | Width 85 mm | In distribution |
| 1290801400 | Height 14 mm | In distribution |
| 1290603000 | Height 30 mm | In distribution |
| 1310651200 | Height 12 mm | In distribution |
| 1421801000 | Height 10 mm | In distribution |
| 1281RT6000 | Width 60 mm | In distribution |
| 1255751000 | Height 10 mm | In distribution |
| 1283750500 | Height 5 mm | In distribution |
| 1310751000 | Height 10 mm | In distribution |
| 1413851000 | Height 10 mm | In distribution |
| 1283801500 | Height 15 mm | In distribution |
| 1290851000 | Height 10 mm | In distribution |
| 1255701200 | Height 12 mm | In distribution |
| 1421752000 | Height 20 mm | In distribution |
| 1290851700 | Height 17 mm | In distribution |
| 1281RT7000 | Width 70 mm | In distribution |
Showing 250 of 275 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243574 | 2025-02-18 |
| K231947 | 2023-10-31 |
| K182125 | 2018-12-06 |
| K171389 | 2017-08-08 |
| K162026 | 2017-03-01 |
| K142550 | 2014-11-07 |
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 |
|---|---|---|---|---|---|
| 2015-02-02 | Class II | Device Design | Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product. | 17 units | 2015-03-19 |
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.