Arthrex®
iBal UKA Tib Cemented Tray, Size 2 LM/RL
6manufacturers in China registered for this device type
199catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2017-02-15 |
| Record revised | 2026-07-08 (version 9) |
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, serial number |
| Distribution end date | 2021-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-501-TBF2 | In distribution | |
| AR-511-T2L | In distribution | |
| AR-513-RC09 | In distribution | |
| AR-503-A709 | In distribution | |
| AR-503-A612 | In distribution | |
| AR-521-TBB0 | In distribution | |
| AR-501-TTRA | In distribution | |
| AR-521-TBC8 | In distribution | |
| AR-501-TBB0 | In distribution | |
| AR-513-RB13 | In distribution | |
| AR-511-T3R | In distribution | |
| AR-501-TTLA | In distribution | |
| AR-517-5R | In distribution | |
| AR-503-TTTJ | In distribution | |
| AR-513-RC14 | In distribution | |
| AR-501-UFRA | In distribution | |
| AR-513-RF09 | In distribution | |
| AR-501-TBC0 | In distribution | |
| AR-521-TBD9 | In distribution | |
| AR-513-BG18 | In distribution | |
| AR-501-TBD2 | In distribution | |
| AR-511-T6R | In distribution | |
| AR-503-A618 | In distribution | |
| AR-503-A616 | In distribution | |
| AR-513-RE10 | In distribution | |
| AR-501-TBC9 | In distribution | |
| AR-501-TBE2 | In distribution | |
| AR-513-BE11 | In distribution | |
| AR-521-TBB4 | In distribution | |
| AR-503-A718 | In distribution | |
| AR-521-TBA1 | In distribution | |
| AR-503-A711 | In distribution | |
| AR-503-A518 | In distribution | |
| AR-501-TBE0 | In distribution | |
| AR-503-A209 | In distribution | |
| AR-501-TBF0 | In distribution | |
| AR-511-T6L | In distribution | |
| AR-513-BF09 | In distribution | |
| AR-511-T5L | In distribution | |
| AR-503-A416 | In distribution | |
| AR-501-TBD1 | In distribution | |
| AR-513-BD12 | In distribution | |
| AR-513-RD13 | In distribution | |
| AR-501-UFLD | In distribution | |
| AR-511-T3L | In distribution | |
| AR-513-BF13 | In distribution | |
| AR-513-RF12 | In distribution | |
| AR-521-TBA4 | In distribution | |
| AR-501-TBF4 | In distribution | |
| AR-513-BE18 | In distribution | |
| AR-501-TBD4 | In distribution | |
| AR-503-A210 | In distribution | |
| AR-521-TBE9 | In distribution | |
| AR-517-8L | In distribution | |
| AR-501-UFRE | In distribution | |
| AR-503-A213 | In distribution | |
| AR-521-TBC2 | In distribution | |
| AR-511-T4L | In distribution | |
| AR-513-BE14 | In distribution | |
| AR-521-TBA0 | In distribution | |
| AR-521-TBB2 | In distribution | |
| AR-513-RE12 | In distribution | |
| AR-501-UFLE | In distribution | |
| AR-501-TTRE | In distribution | |
| AR-501-TBA8 | In distribution | |
| AR-513-RE09 | In distribution | |
| AR-521-TBC0 | In distribution | |
| AR-513-BC10 | In distribution | |
| AR-503-TTTG | In distribution | |
| AR-503-A409 | In distribution | |
| AR-501-TBB2 | In distribution | |
| AR-503-A608 | In distribution | |
| AR-501-TBA2 | In distribution | |
| AR-521-TBC4 | In distribution | |
| AR-501-TTRC | In distribution | |
| AR-503-A811 | In distribution | |
| AR-513-BH12 | In distribution | |
| AR-511-T2R | In distribution | |
| AR-513-BC13 | In distribution | |
| AR-501-TBD8 | In distribution | |
| AR-521-TBE1 | In distribution | |
| AR-501-UFRD | In distribution | |
| AR-521-TBD4 | In distribution | |
| AR-521-TBD0 | In distribution | |
| AR-521-TBB9 | In distribution | |
| AR-513-RB14 | In distribution | |
| AR-521-TBB8 | In distribution | |
| AR-501-TBE4 | In distribution | |
| AR-501-UFLB | In distribution | |
| AR-521-TBC1 | In distribution | |
| AR-521-TBF8 | In distribution | |
| AR-501-TBF9 | In distribution | |
| AR-513-BF10 | In distribution | |
| AR-513-RE08 | In distribution | |
| AR-513-BB14 | In distribution | |
| AR-501-TBA0 | In distribution | |
| AR-521-TBF1 | In distribution | |
| AR-503-A410 | In distribution | |
| AR-513-BB11 | In distribution | |
| AR-513-RB16 | In distribution | |
| AR-513-BH18 | In distribution | |
| AR-501-TBD0 | In distribution | |
| AR-513-RG13 | In distribution | |
| AR-501-TBC2 | In distribution | |
| AR-501-TTRD | In distribution | |
| AR-513-BG16 | In distribution | |
| AR-513-RJ18 | In distribution | |
| AR-501-TBF1 | In distribution | |
| AR-521-TBE4 | In distribution | |
| AR-513-BF12 | In distribution | |
| AR-521-TBD1 | In distribution | |
| AR-513-BB20 | In distribution | |
| AR-501-UFLF | In distribution | |
| AR-501-TBE9 | In distribution | |
| AR-516-3L | In distribution | |
| AR-511-T5R | In distribution | |
| AR-513-BC14 | In distribution | |
| AR-503-A314 | In distribution | |
| AR-521-TBF0 | In distribution | |
| AR-513-BG13 | In distribution | |
| AR-501-UFRB | In distribution | |
| AR-501-UFLA | In distribution | |
| AR-521-TBE8 | In distribution | |
| AR-517-3L | In distribution | |
| AR-501-UFLC | In distribution | |
| AR-501-TBC1 | In distribution | |
| AR-501-TBF8 | In distribution | |
| AR-501-TTRF | In distribution | |
| AR-521-TBD8 | In distribution | |
| AR-521-TBE0 | In distribution | |
| AR-503-A308 | In distribution | |
| AR-503-A318 | In distribution | |
| AR-513-BJ16 | In distribution | |
| AR-503-TTTE | In distribution | |
| AR-513-BG08 | In distribution | |
| AR-513-BJ09 | In distribution | |
| AR-501-TBE8 | In distribution | |
| AR-521-TBA9 | In distribution | |
| AR-513-BJ11 | In distribution | |
| AR-521-TBA8 | In distribution | |
| AR-503-A214 | In distribution | |
| AR-521-TBF9 | In distribution | |
| AR-513-RC10 | In distribution | |
| AR-501-UFRC | In distribution | |
| AR-513-BB18 | In distribution | |
| AR-501-TBD9 | In distribution | |
| AR-521-TBD2 | In distribution | |
| AR-503-A310 | In distribution | |
| AR-521-TBC9 | In distribution | |
| AR-501-TTLE | In distribution | |
| AR-521-TBF4 | In distribution | |
| AR-501-TBA1 | In distribution | |
| AR-501-TBB9 | In distribution | |
| AR-501-TTLC | In distribution | |
| AR-501-TTLB | In distribution | |
| AR-513-BJ10 | In distribution | |
| AR-503-A610 | In distribution | |
| AR-503-A512 | In distribution | |
| AR-511-T1L | In distribution | |
| AR-513-BE20 | In distribution | |
| AR-501-TBA4 | In distribution | |
| AR-503-A816 | In distribution | |
| AR-517-3R | In distribution | |
| AR-513-BE12 | In distribution | |
| AR-511-T4R | In distribution | |
| AR-503-A809 | In distribution | |
| AR-513-BH16 | In distribution | |
| AR-503-A511 | In distribution | |
| AR-501-TTLF | In distribution | |
| AR-501-TBB8 | In distribution | |
| AR-501-TBB1 | In distribution | |
| AR-513-RG14 | In distribution | |
| AR-513-BH08 | In distribution | |
| AR-516-3R | In distribution | |
| AR-503-A712 | In distribution | |
| AR-521-TBB1 | In distribution | |
| AR-503-A313 | In distribution | |
| AR-501-UFRF | In distribution | |
| AR-521-TBE2 | In distribution | |
| AR-501-TTRB | In distribution | |
| AR-502-4L | In distribution | |
| AR-521-TBF2 | In distribution | |
| AR-501-TBC8 | In distribution | |
| AR-513-RG11 | In distribution | |
| AR-501-TBA9 | In distribution | |
| AR-513-RD09 | In distribution | |
| AR-511-T1R | In distribution | |
| AR-501-TBE1 | In distribution | |
| AR-501-TTLD | In distribution | |
| AR-501-TBC4 | In distribution | |
| AR-503-A810 | In distribution | |
| AR-501-TBB4 | In distribution | |
| AR-521-TBA2 | In distribution | |
| AR-517-2R | In distribution | |
| AR-517-1L | In distribution | |
| AR-513-BJ14 | In distribution | |
| AR-503-A609 | In distribution | |
| RAR-501-S | Withdrawn | |
| AR-501-S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
| Genesis | Smith & Nephew, Inc. | 118 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251453 | 2025-07-01 |
| K200433 | 2020-03-17 |
| K161060 | 2016-12-15 |
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 |
|---|---|---|---|---|---|
| 2017-10-03 | Class II | Process control | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box. | 20 units | 2018-12-04 |
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.