Truliant®
Truliant is a total knee replacement system comprising femoral, tibial and patellar implants. The K240393 filing covers additional porous tibial tray variants intended for use with this…
Truliant is a total knee replacement system comprising femoral, tibial and patellar implants. The K240393 filing covers additional porous tibial tray variants intended for use with this system.
The filing indicates primary total knee replacement in skeletally mature individuals with osteoarthritis, osteonecrosis, rheumatoid arthritis or post-traumatic degenerative problems. It also covers revision of failed prior reconstructions when sufficient bone stock and soft tissue integrity are present.
Listed Item
Special Low Profile Truliant Tibial Resection Block, 3 Degree Posterior Slope, Right
Tibial Tray Variants
The subject variants are porous tibial trays made from titanium alloy by direct metal laser sintering. The filing specifies cemented or cementless use for porous tibial trays; its cemented femoral components, tibial inserts and tibial trays are indicated for cemented use only.
12manufacturers in China registered for this device type
142catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K240393 |
| Record published | 2024-11-08 |
| Record revised | 2023-10-04 (version 3) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-022-56-4545 | Size 4.5F/4.5T | In distribution |
| 02-022-55-2525 | 2.5F/2.5T | In distribution |
| 02-022-55-2010 | 2F/1T | In distribution |
| 02-022-56-1010 | Size 1F/1T | In distribution |
| 02-029-29-2100 | In distribution | |
| 02-020-12-0220 | Left | In distribution |
| 02-029-15-2000 | SIZE 0 | In distribution |
| 02-029-13-8030 | SIZE 3 | In distribution |
| 02-029-15-3040 | SIZE 4 | In distribution |
| 02-022-56-4535 | Size 4.5F/3.5T | In distribution |
| 02-022-56-3020 | Size 3F/2T | In distribution |
| 02-029-22-1320 | MEDIUM | In distribution |
| 02-029-15-3050 | SIZE 5 | In distribution |
| 02-020-14-0220 | Left | In distribution |
| 02-020-14-0315 | Right | In distribution |
| SPI-040344 | In distribution | |
| 02-022-56-4555 | Size 4.5F/5.5T | In distribution |
| 02-020-14-0230 | Left | In distribution |
| 02-022-57-4040 | Size 4F/4T | In distribution |
| 02-029-15-3030 | SIZE 3 | In distribution |
| 02-022-57-3025 | Size 3F/2.5T | In distribution |
| 02-022-57-4035 | Size 4F/3.5T | In distribution |
| 02-022-56-1005 | Size 1F/0.5T | In distribution |
| 02-022-56-2010 | Size 2F/1T | In distribution |
| 02-022-56-3545 | Size 3.5F/4.5T | In distribution |
| 02-022-56-2520 | Size 2.5F/2T | In distribution |
| 02-029-45-0000 | In distribution | |
| 02-022-57-4550 | Size 4.5F/5T | In distribution |
| 02-022-56-5040 | Size 5F/4T | In distribution |
| 02-022-55-1000 | 1F/0T | In distribution |
| 02-022-55-4050 | 4F/5T | In distribution |
| 02-020-12-0210 | Left | In distribution |
| 02-022-57-4050 | Size 4F/5T | In distribution |
| 02-022-56-2525 | Size 2.5F/2.5T | In distribution |
| 02-029-19-1000 | In distribution | |
| SPI-039616 | In distribution | |
| 02-022-56-2020 | Size 2F/2T | In distribution |
| 02-022-55-1020 | 1F/2T | In distribution |
| 02-022-57-2525 | Size 2.5F/2.5T | In distribution |
| 02-022-56-1000 | Size 1F/0T | In distribution |
| 02-020-14-0335 | Right | In distribution |
| 02-020-14-0250 | Left | In distribution |
| 02-022-55-2030 | 2F/3T | In distribution |
| 02-022-55-4030 | 4F/3T | In distribution |
| 02-022-56-1525 | Size 1.5F/2.5T | In distribution |
| 02-022-57-0010 | Size 0F/1T | In distribution |
| 02-029-90-1000 | In distribution | |
| 02-020-14-0300 | Right | In distribution |
| 02-022-57-5040 | Size 5F/4T | In distribution |
| 02-022-57-3540 | Size 3.5F/4T | In distribution |
| 02-029-15-2025 | SIZE 2.5 | In distribution |
| SPI-040343 | In distribution | |
| 02-029-29-2000 | In distribution | |
| 02-022-56-3040 | Size 3F/4T | In distribution |
| 02-022-57-4045 | Size 4F/4.5T | In distribution |
| 02-020-12-0230 | Left | In distribution |
| 02-020-12-0250 | Left | In distribution |
| 02-020-14-0360 | Right | In distribution |
| 02-022-56-3540 | Size 3.5F/4T | In distribution |
| 02-020-14-0345 | Right | In distribution |
| 02-022-57-2025 | Size 2F/2.5T | In distribution |
| 02-022-56-1515 | Size 1.5F/1.5T | In distribution |
| 02-020-12-0240 | Left | In distribution |
| 02-022-56-2535 | Size 2.5F/3.5T | In distribution |
| SPI-008225 | In distribution | |
| SPI-046442 | In distribution | |
| 02-022-57-1525 | Size 1.5F/2.5T | In distribution |
| 02-020-12-0315 | Right | In distribution |
| 02-029-15-3035 | SIZE 3.5 | In distribution |
| SPI-009429 | In distribution | |
| 02-022-57-3535 | Size 3.5F/3.5T | In distribution |
| 02-022-55-1515 | 1.5F/1.5T | In distribution |
| 02-022-56-3025 | Size 3F/2.5T | In distribution |
| 02-022-56-0000 | Size 0F/0T | In distribution |
| 02-022-56-1020 | Size 1F/2T | In distribution |
| 02-022-57-3525 | Size 3.5F/2.5T | In distribution |
| 02-022-57-3545 | Size 3.5F/4.5T | In distribution |
| 02-022-57-4535 | Size 4.5F/3.5T | In distribution |
| 02-022-56-5045 | Size 5F/4.5T | In distribution |
| 02-029-90-6000 | In distribution | |
| 02-022-55-3040 | 3F/4T | In distribution |
| 02-029-15-2050 | SIZE 5 | In distribution |
| 02-022-55-3020 | 3F/2T | In distribution |
| 02-022-55-0000 | 0F/0T | In distribution |
| 02-020-12-0335 | Right | In distribution |
| SPI-055810 | In distribution | |
| 02-022-56-4045 | Size 4F/4.5T | In distribution |
| 02-022-57-4555 | Size 4.5F/5.5T | In distribution |
| 02-022-57-1505 | Size 1.5F/0.5T | In distribution |
| 02-020-14-0240 | Left | In distribution |
| SPI-009146 | In distribution | |
| 02-020-12-0345 | Right | In distribution |
| 02-022-56-4035 | Size 4F/3.5T | In distribution |
| 02-022-56-0005 | Size 0F/0.5T | In distribution |
| 02-022-57-4545 | Size 4.5F/4.5T | In distribution |
| 02-022-57-4030 | Size 4F/3T | In distribution |
| 02-022-57-1000 | Size 1F/0T | In distribution |
| 02-029-13-8040 | SIZE 4 | In distribution |
| 02-029-22-1330 | LARGE | In distribution |
| 02-029-13-8050 | SIZE 5 | In distribution |
| 02-029-15-3020 | SIZE 2 | In distribution |
| 02-022-57-2015 | Size 2F/1.5T | In distribution |
| SPI-008285 | In distribution | |
| 02-029-21-4000 | In distribution | |
| 02-020-12-0300 | Right | In distribution |
| 02-022-57-0005 | Size 0F/0.5T | In distribution |
| SPI-040152 | In distribution | |
| 02-022-55-5040 | 5F/4T | In distribution |
| 02-029-15-2010 | SIZE 1 | In distribution |
| 02-029-29-4000 | In distribution | |
| 02-022-55-3535 | 3.5F/3.5T | In distribution |
| 02-029-29-3100 | LARGE | In distribution |
| 02-020-12-0360 | Right | In distribution |
| 02-022-57-1510 | Size 1.5F/1T | In distribution |
| 02-022-55-4545 | 4.5F/4.5T | In distribution |
| 02-022-57-3040 | Size 3F/4T | In distribution |
| 02-022-57-1515 | Size 1.5F/1.5T | In distribution |
| 02-022-56-4050 | Size 4F/5T | In distribution |
| 02-022-57-3020 | Size 3F/2T | In distribution |
| 02-022-57-1020 | Size 1F/2T | In distribution |
| 02-029-22-1310 | SMALL | In distribution |
| 02-020-12-0325 | Right | In distribution |
| 02-029-15-3025 | SIZE 2.5 | In distribution |
| 02-029-21-8020 | In distribution | |
| 02-022-57-1015 | Size 1F/1.5T | In distribution |
| 02-022-55-5060 | 5F/6T | In distribution |
| 02-029-13-8010 | SIZE 1 | In distribution |
| 02-022-56-4040 | Size 4F/4T | In distribution |
| 02-022-56-4540 | Size 4.5F/4T | In distribution |
| 02-022-56-4030 | Size 4F/3T | In distribution |
| 02-029-15-2020 | SIZE 2 | In distribution |
| 02-022-55-6060 | 6F/6T | In distribution |
| 02-022-57-3030 | Size 3F/3T | In distribution |
| 02-029-13-8015 | SIZE 1.5 | In distribution |
| 02-022-56-4550 | Size 4.5F/5T | In distribution |
| 02-022-56-3030 | Size 3F/3T | In distribution |
| 02-022-57-3035 | Size 3F/3.5T | In distribution |
| 02-020-14-0210 | Left | In distribution |
| 02-029-29-3200 | In distribution | |
| 02-022-57-1520 | Size 1.5F/2T | In distribution |
| 02-020-14-0325 | Right | In distribution |
| 02-022-56-3530 | Size 3.5F/3T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Vanguard Knee System | Biomet Orthopedics | 125 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240393 | 2024-10-03 |
| K182346 | 2018-11-26 |
| K181794 | 2018-09-28 |
| K153776 | 2016-03-10 |
| K140302 | 2014-07-30 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | |
| Exactech, Inc. | 510(k) number | 2021-08-30 | Class II | Process control | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | 31,201 devices |
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.