Maxim Accel Knee System
11 catalogue numbers from RD255008, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Biomet Orthopedics, 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 |
| 510(k) | K023546 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
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 |
| Sizes | Height 11 to 13 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RD255008 | 67.5 MM | In distribution |
| SSI003709 | Tibia: 71/75 | In distribution |
| SSI003708 | Height 13 mm | In distribution |
| SSI003711 | Tibia: 79/83 | In distribution |
| SSI003712 | Height 13 mm | In distribution |
| RD255004 | 75 MM | In distribution |
| RD255013 | 70 MM | In distribution |
| SSI003707 | Tibia: 63/67 | In distribution |
| RD255011 | 60 MM | In distribution |
| RD255012 | 65 MM | In distribution |
| SSI003710 | Height 13 mm | In distribution |
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 |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
Recalls Naming This Product
13 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 | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 46 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 93 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2018-10-22 | Class II | Labeling mix-ups | Label on the outer carton or the patient labels does not match label on the inner sterile packaging | 8 units | 2019-12-11 |
| Biomet, Inc. | 510(k) number | 2017-09-29 | Class II | Labeling mix-ups | Knee implant components (tibial bearings) are labeled with the incorrect size. | 24 | 2019-04-17 |
| Biomet, Inc. | 510(k) number | 2017-09-29 | Class II | Labeling mix-ups | Knee implant components (tibial bearings) are labeled with the incorrect size. | 24 | 2019-04-17 |
| Biomet, Inc. | 510(k) number | 2017-01-04 | Class II | Process change control | packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery. | 15,000 | 2018-06-11 |
| Biomet, Inc. | 510(k) number | 2016-08-09 | Class II | Labeling mix-ups | Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a r | 5 | 2017-05-17 |
| Biomet, Inc. | 510(k) number | 2011-07-06 | Not classified | Employee error | The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless. | 8 | 2012-09-26 |
| Biomet, Inc. | 510(k) number | 2010-04-20 | Not classified | Process control | A knee implant labeled as left was opened and the package actually contained a right knee implant. | 5 | 2011-01-19 |
| Biomet, Inc. | 510(k) number | 2008-02-12 | Not classified | Packaging process control | Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i | 4 | 2009-12-22 |
| Biomet, Inc. | 510(k) number | 2008-02-12 | Not classified | Packaging process control | Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result i | 8 | 2009-12-22 |
| Biomet, Inc. | 510(k) number | 2007-08-31 | Not classified | Packaging process control | Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component. | 16 | 2008-06-04 |
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.