Balanced Knee System Revision
Tibial Augment 10mm Block Lt. Lat/Rt Med Sz 5
21manufacturers in China registered for this device type
83catalogue numbers in this listing
15510(k) clearances naming this product code
14recalls on this 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 | Ortho Development Corp., 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060569 |
| Record published | 2021-01-25 |
| Record revised | 2023-02-03 (version 2) |
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 |
| Sizes | Height 2 to 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 568-2504A | Height 4 mm | In distribution |
| 567-6205A | Height 10 mm | In distribution |
| 567-7203A | Height 15 mm | In distribution |
| 568-2104A | Height 4 mm | In distribution |
| 568-1204A | Height 4 mm | In distribution |
| 567-7201A | Height 15 mm | In distribution |
| 568-1504A | Height 4 mm | In distribution |
| 567-6101A | Height 10 mm | In distribution |
| 568-1208A | Height 8 mm | In distribution |
| 567-6106A | Height 10 mm | In distribution |
| 567-5205A | Height 5 mm | In distribution |
| 568-1412A | Height 12 mm | In distribution |
| 568-2208A | Height 8 mm | In distribution |
| 568-1604A | Height 4 mm | In distribution |
| 567-5103A | Height 5 mm | In distribution |
| 567-7202A | Height 15 mm | In distribution |
| 568-2102A | Height 2 mm | In distribution |
| 567-5104A | Height 5 mm | In distribution |
| 567-5207A | Height 5 mm | In distribution |
| 567-5203A | Height 5 mm | In distribution |
| 568-1308A | Height 8 mm | In distribution |
| 567-7106A | Height 15 mm | In distribution |
| 568-1212A | Height 12 mm | In distribution |
| 567-7207A | Height 15 mm | In distribution |
| 567-5201A | Height 5 mm | In distribution |
| 568-1612A | Height 12 mm | In distribution |
| 568-1108A | Height 8 mm | In distribution |
| 568-2404A | Height 4 mm | In distribution |
| 568-2308A | Height 8 mm | In distribution |
| 567-5106A | Height 5 mm | In distribution |
| 567-6202A | Height 10 mm | In distribution |
| 568-2604A | Height 4 mm | In distribution |
| 568-1704A | Height 4 mm | In distribution |
| 567-5105A | Height 5 mm | In distribution |
| 568-2708A | Height 8 mm | In distribution |
| 567-5107A | Height 5 mm | In distribution |
| 567-6104A | Height 10 mm | In distribution |
| 568-2702A | Height 2 mm | In distribution |
| 567-7105A | Height 15 mm | In distribution |
| 568-2204A | Height 4 mm | In distribution |
| 568-2408A | Height 8 mm | In distribution |
| 568-1404A | Height 4 mm | In distribution |
| 567-6107A | Height 10 mm | In distribution |
| 568-1512A | Height 12 mm | In distribution |
| 567-5206A | Height 5 mm | In distribution |
| 568-2602A | Height 2 mm | In distribution |
| 568-1712A | Height 12 mm | In distribution |
| 567-7204A | Height 15 mm | In distribution |
| 568-1408A | Height 8 mm | In distribution |
| 568-1312A | Height 12 mm | In distribution |
| 567-6201A | Height 10 mm | In distribution |
| 567-6206A | Height 10 mm | In distribution |
| 567-7205A | Height 15 mm | In distribution |
| 567-6207A | Height 10 mm | In distribution |
| 567-7101A | Height 15 mm | In distribution |
| 567-6102A | Height 10 mm | In distribution |
| 568-2502A | Height 2 mm | In distribution |
| 567-7107A | Height 15 mm | In distribution |
| 567-5102A | Height 5 mm | In distribution |
| 567-7206A | Height 15 mm | In distribution |
| 567-5204A | Height 5 mm | In distribution |
| 568-2608A | Height 8 mm | In distribution |
| 568-2108A | Height 8 mm | In distribution |
| 568-1708A | Height 8 mm | In distribution |
| 568-1608A | Height 8 mm | In distribution |
| 567-7104A | Height 15 mm | In distribution |
| 568-1508A | Height 8 mm | In distribution |
| 568-2304A | Height 4 mm | In distribution |
| 567-5202A | Height 5 mm | In distribution |
| 568-2402A | Height 2 mm | In distribution |
| 567-6105A | Height 10 mm | In distribution |
| 568-1104A | Height 4 mm | In distribution |
| 567-6103A | Height 10 mm | In distribution |
| 568-2508A | Height 8 mm | In distribution |
| 568-2302A | Height 2 mm | In distribution |
| 567-6204A | Height 10 mm | In distribution |
| 568-2704A | Height 4 mm | In distribution |
| 568-2202A | Height 2 mm | In distribution |
| 567-7103A | Height 15 mm | In distribution |
| 568-1304A | Height 4 mm | In distribution |
| 567-7102A | Height 15 mm | In distribution |
| 567-6203A | Height 10 mm | In distribution |
| 567-5101A | Height 5 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 |
|---|---|
| K242984 | 2024-10-25 |
| K233093 | 2023-10-25 |
| K182085 | 2018-10-31 |
| K181569 | 2018-10-12 |
| K180743 | 2018-06-20 |
| K152169 | 2015-10-27 |
| K133449 | 2014-02-18 |
| K131337 | 2013-10-11 |
| K123457 | 2013-03-22 |
| K103837 | 2011-03-24 |
| K090705 | 2009-10-09 |
| K060569 | 2006-07-06 |
| K031201 | 2003-07-15 |
| K020383 | 2002-05-06 |
| K994370 | 2000-03-24 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Ortho Development Corp. | 510(k) number | 2014-07-11 | Class II | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increase | 1 | 2014-10-06 |
| Ortho Development Corp. | 510(k) number | 2011-01-07 | Not classified | Error in labeling | Components of a replacement knee system could be mislabeled. | 25 units | 2011-12-27 |
| Ortho Development Corp. | 510(k) number | 2011-01-07 | Not classified | Error in labeling | Components of a replacement knee system could be mislabeled. | 14 units (US), 2 (Intnl) | 2011-12-27 |
| Ortho Development Corp. | 510(k) number | 2011-01-07 | Not classified | Error in labeling | Components of a replacement knee system could be mislabeled. | 33 units (US) | 2011-12-27 |
| Ortho Development Corp. | 510(k) number | 2009-03-19 | Not classified | Device Design | A component of knee prosthesis was assembled incorrectly. | 422 units | 2010-06-30 |
| Ortho Development Corp. | 510(k) number | 2009-03-19 | Not classified | Device Design | A component of knee prosthesis was assembled incorrectly. | 368 units | 2010-06-30 |
Recalls
6 of these are 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 |
|---|---|---|---|---|---|
| 2019-05-30 | Class II | Nonconforming Material/Component | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the “T” and “Y” junctions, which may cause resistance when the Tibial Insert was being assembled. | 29 | |
| 2019-05-30 | Class II | Nonconforming Material/Component | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the “T” and “Y” junctions, which may cause resistance when the Tibial Insert was being assembled. | 27 | |
| 2014-07-11 | Class II | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increase | 13 | 2014-10-06 |
| 2014-07-11 | Class II | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increase | 14 | 2014-10-06 |
| 2014-07-11 | Class II | Packaging process control | Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increase | 11 | 2014-10-06 |
| 2014-04-01 | Class II | Process control | A femoral component containing pegs was found in a box for the pegless version. | 5 | 2014-07-14 |
| 2009-05-29 | Not classified | Mixed-up of materials/components | Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). | 13 units | 2010-05-11 |
| 2003-09-15 | Not classified | Other | The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out. | 27 | 2003-12-11 |
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.