UniCAP®
Articular Implant, 3.0 x 1.0mm, Uni, Small
6manufacturers in China registered for this device type
56catalogue numbers in this listing
1510(k) clearance
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 | Arthrosurface, 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 | Specification developer, Manufacturer, Exporter |
| 510(k) | K050373 |
| Record published | 2015-09-15 |
| Record revised | 2018-07-06 (version 3) |
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 | Outer diameter 7.5 to 20 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U202-0631-W | In distribution | |
| U110-0218-W | Outer Diameter 12 mm | In distribution |
| US02-3010-A | In distribution | |
| US02-3510-W | In distribution | |
| U202-0831-W | In distribution | |
| U202-0935-A | In distribution | |
| U202-0631-A | In distribution | |
| U205-0510-W | Outer Diameter 20 mm | In distribution |
| U202-0925-A | In distribution | |
| U205-0515-A | Outer Diameter 20 mm | In distribution |
| U205-0505-A | Outer Diameter 20 mm | In distribution |
| US02-3510-A | In distribution | |
| US02-3520-A | In distribution | |
| U202-0721-W | In distribution | |
| U202-1035-W | In distribution | |
| U205-0505-W | Outer Diameter 20 mm | In distribution |
| U000-0510 | In distribution | |
| U202-1025-W | In distribution | |
| US02-4020-W | In distribution | |
| U205-1015-W | Outer Diameter 20 mm | In distribution |
| U202-0925-W | In distribution | |
| US02-2520-W | In distribution | |
| U205-0010-A | Outer Diameter 20 mm | In distribution |
| U202-0721-A | In distribution | |
| US11-0205-W | In distribution | |
| U202-0731-A | In distribution | |
| U202-0621-W | In distribution | |
| U075-0173-W | Outer Diameter 7.5 mm | In distribution |
| U202-1035-A | In distribution | |
| U202-1025-A | In distribution | |
| US02-3020-A | In distribution | |
| U202-0821-A | In distribution | |
| US02-4010-W | In distribution | |
| US02-3020-W | In distribution | |
| US02-4020-A | In distribution | |
| U205-0510-A | Outer Diameter 20 mm | In distribution |
| U205-1015-A | Outer Diameter 20 mm | In distribution |
| U000-0200 | In distribution | |
| U202-0731-W | In distribution | |
| US11-0205-A | In distribution | |
| U202-0821-W | In distribution | |
| U205-0010-W | Outer Diameter 20 mm | In distribution |
| U202-0935-W | In distribution | |
| U205-1010-A | Outer Diameter 20 mm | In distribution |
| U205-1010-W | Outer Diameter 20 mm | In distribution |
| US02-2510-W | In distribution | |
| U000-0100 | In distribution | |
| U110-0218-A | Outer Diameter 12 mm | In distribution |
| US02-2520-A | In distribution | |
| U205-0515-W | Outer Diameter 20 mm | In distribution |
| US02-3010-W | In distribution | |
| U202-0831-A | In distribution | |
| US02-4010-A | In distribution | |
| US02-2510-A | In distribution | |
| US02-3520-W | In distribution | |
| U202-0621-A | In distribution |
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 |
| Arthrex® | Arthrex, Inc. | 199 |
| 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 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K050373 | 2005-10-11 |
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.