Revision Knee System
RKS, Distal Fem Cut Guide, 0-5mm Femoral/0-10mm Tibial
21manufacturers in China registered for this device type
102catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou | Guangdong | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Showing 12 of 21. All 21 manufacturers in China registered for Template
Record
| Listed by | Shalby Advanced Technologies, Inc., United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-05-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2979-0-2001 | Trial, Peg, Augment, S | In distribution |
| 2978-1-0003 | Sizer, Tibial Baseplate, Right, Size 3 | In distribution |
| 2973-0-0004 | Trial, Tibial Baseplate, Left, Size 4 | In distribution |
| 2971-0-0810 | Trial, Stem, Straight, 10mm x 80mm | In distribution |
| 2971-0-0816 | Trial, Stem, Straight, 16mm x 80mm | In distribution |
| 2974-0-0001 | Trial, Tibial Basplate, Right, Size 1 | In distribution |
| 2974-0-0003 | Trial, Tibial Basplate, Right, Size 3 | In distribution |
| 2979-0-1001 | Trial, Augment, Posterior Femoral, Size 1 | In distribution |
| 2983-0-0512 | Trial, Augment, Tibial, Size 1 Med/2 Lat, 5mm | In distribution |
| 2982-0-0004 | Femoral AP Cutting Block, Right, Size 4 | In distribution |
| 2982-0-0003 | Femoral AP Cutting Block, Right, Size 3 | In distribution |
| 2979-0-1003 | Trial, Augment, Posterior Femoral, Size 3 | In distribution |
| 2983-0-0556 | Trial, Augment, Tibial, Size 5 Med/6 Lat, 5mm | In distribution |
| 2981-0-0003 | Femoral AP Cutting Block, Left, Size 3 | In distribution |
| 2975-0-0002 | Trial, Femoral Component, Left, Size 2 | In distribution |
| 2982-0-0005 | Femoral AP Cutting Block, Right, Size 5 | In distribution |
| 2977-1-0004 | Sizer, Tibial Baseplate, Left, Size 4 | In distribution |
| 2975-0-0003 | Trial, Femoral Component, Left, Size 3 | In distribution |
| 2970-0-0007 | Distal Fem Cut Guide, 0-5mm Femoral/0-10mm Tibial | In distribution |
| 2978-1-0004 | Sizer, Tibial Baseplate, Right, Size 4 | In distribution |
| 2971-0-0814 | Trial, Stem, Straight, 14mm x 80mm | In distribution |
| 2979-0-0034 | Trial, Augment, Distal Femoral, Size 3/4 | In distribution |
| 2976-0-0001 | Trial, Femoral Component, Right, Size 1 | In distribution |
| 2971-0-1512 | Trial, Stem, Straight, 12mm x 150mm | In distribution |
| 2973-0-0001 | Trial, Tibial Baseplate, Left, Size 1 | In distribution |
| 2971-0-1118 | Trial, Stem, Straight, 18mm x 110mm | In distribution |
| 2979-0-2003 | Trial, Peg, Augment, L | In distribution |
| 2979-0-1004 | Trial, Augment, Posterior Femoral, Size 4 | In distribution |
| 2978-1-0005 | Sizer, Tibial Baseplate, Right, Size 5 | In distribution |
| 2973-0-0005 | Trial, Tibial Baseplate, Left, Size 5 | In distribution |
| 2971-0-1122 | Trial, Stem, Straight, 22mm x 110mm | In distribution |
| 2975-0-0001 | Trial, Femoral Component, Left, Size 1 | In distribution |
| 2975-0-0004 | Trial, Femoral Component, Left, Size 4 | In distribution |
| 2971-0-1116 | Trial, Stem, Straight, 16mm x 110mm | In distribution |
| 2970-0-0011 | Trial, Screw, Flat Head, S | In distribution |
| 2976-0-0005 | Trial, Femoral Component, Right, Size 5 | In distribution |
| 2971-0-1510 | Trial, Stem, Straight, 10mm x 150mm | In distribution |
| 2979-0-2002 | Trial, Peg, Augment, M | In distribution |
| 2976-0-0004 | Trial, Femoral Component, Right, Size 4 | In distribution |
| 2974-0-0002 | Trial, Tibial Basplate, Right, Size 2 | In distribution |
| 2978-1-0001 | Sizer, Tibial Baseplate, Right, Size 1 | In distribution |
| 2971-0-1514 | Trial, Stem, Straight, 14mm x 150mm | In distribution |
| 2976-0-0002 | Trial, Femoral Component, Right, Size 2 | In distribution |
| 2979-0-1002 | Trial, Augment, Posterior Femoral, Size 2 | In distribution |
| 2977-1-0001 | Sizer, Tibial Baseplate, Left, Size 1 | In distribution |
| 2971-0-0812 | Trial, Stem, Straight, 12mm x 80mm | In distribution |
| 2981-0-0002 | Femoral AP Cutting Block, Left, Size 2 | In distribution |
| 2976-0-0003 | Trial, Femoral Component, Right, Size 3 | In distribution |
| 2983-0-1001 | Trial, Augment, Tibial, Size 0 Med/1 Lat, 10mm | In distribution |
| 2983-0-1034 | Trial, Augment, Tibial, Size 3 Med/4 Lat, 10mm | In distribution |
| 2974-0-0004 | Trial, Tibial Basplate, Right, Size 4 | In distribution |
| 2979-0-1006 | Trial, Augment, Posterior Femoral, Size 6 | In distribution |
| 2983-0-0534 | Trial, Augment, Tibial, Size 3 Med/4 Lat, 5mm | In distribution |
| 2973-0-0003 | Trial, Tibial Baseplate, Left, Size 3 | In distribution |
| 2982-0-0002 | Femoral AP Cutting Block, Right, Size 2 | In distribution |
| 2981-0-0001 | Femoral AP Cutting Block, Left, Size 1 | In distribution |
| 2979-0-1005 | Trial, Augment, Posterior Femoral, Size 5 | In distribution |
| 2975-0-0006 | Trial, Femoral Component, Left, Size 6 | In distribution |
| 2979-0-0002 | Trial, Augment, Distal Femoral, Size 2 | In distribution |
| 2977-1-0002 | Sizer, Tibial Baseplate, Left, Size 2 | In distribution |
| 2982-0-0006 | Femoral AP Cutting Block, Right, Size 6 | In distribution |
| 2983-0-1012 | Trial, Augment, Tibial, Size 1 Med/2 Lat, 10mm | In distribution |
| 2971-0-1522 | Trial, Stem, Straight, 22mm x 150mm | In distribution |
| 2981-0-0005 | Femoral AP Cutting Block, Left, Size 5 | In distribution |
| 2974-0-0005 | Trial, Tibial Basplate, Right, Size 5 | In distribution |
| 2976-0-0006 | Trial, Femoral Component, Right, Size 6 | In distribution |
| 2981-0-0004 | Femoral AP Cutting Block, Left, Size 4 | In distribution |
| 2983-0-1056 | Trial, Augment, Tibial, Size 5 Med/6 Lat, 10mm | In distribution |
| 2983-0-1060 | Trial, Augment, Tibial, Size 6 Med, 10mm | In distribution |
| 2983-0-1023 | Trial, Augment, Tibial, Size 2 Med/3 Lat, 10mm | In distribution |
| 2971-0-1112 | Trial, Stem, Straight, 12mm x 110mm | In distribution |
| 2971-0-1114 | Trial, Stem, Straight, 14mm x 110mm | In distribution |
| 2975-0-0005 | Trial, Femoral Component, Left, Size 5 | In distribution |
| 2983-0-0560 | Trial, Augment, Tibial, Size 6 Med, 5mm | In distribution |
| 2978-1-0006 | Sizer, Tibial Baseplate, Right, Size 6 | In distribution |
| 2973-0-0006 | Trial, Tibial Baseplate, Left, Size 6 | In distribution |
| 2970-0-0012 | Trial, Screw, Flat Head, L | In distribution |
| 2982-0-0001 | Femoral AP Cutting Block, Right, Size 1 | In distribution |
| 2974-0-0006 | Trial, Tibial Basplate, Right, Size 6 | In distribution |
| 2981-0-0006 | Femoral AP Cutting Block, Left, Size 6 | In distribution |
| 2983-0-0545 | Trial, Augment, Tibial, Size 4 Med/5 Lat, 5mm | In distribution |
| 2971-0-1120 | Trial, Stem, Straight, 20mm x 110mm | In distribution |
| 2971-0-1110 | Trial, Stem, Straight, 10mm x 110mm | In distribution |
| 2978-1-0002 | Sizer, Tibial Baseplate, Right, Size 2 | In distribution |
| 2971-0-1518 | Trial, Stem, Straight, 18mm x 150mm | In distribution |
| 2983-0-1045 | Trial, Augment, Tibial, Size 4 Med/5 Lat, 10mm | In distribution |
| 2971-0-0818 | Trial, Stem, Straight, 18mm x 80mm | In distribution |
| 2973-0-0002 | Trial, Tibial Baseplate, Left, Size 2 | In distribution |
| 2971-0-0820 | Trial, Stem, Straight, 20mm x 80mm | In distribution |
| 2971-0-0822 | Trial, Stem, Straight, 22mm x 80mm | In distribution |
| 2979-0-0056 | Trial, Augment, Distal Femoral, Size 5/6 | In distribution |
| 2970-0-0003 | Trial, Plug, Taper | In distribution |
| 2983-0-0501 | Trial, Augment, Tibial, Size 0 Med/1 Lat, 5mm | In distribution |
| 2971-0-1520 | Trial, Stem, Straight, 20mm x 150mm | In distribution |
| 2977-1-0005 | Sizer, Tibial Baseplate, Left, Size 5 | In distribution |
| 2983-0-0523 | Trial, Augment, Tibial, Size 2 Med/3 Lat, 5mm | In distribution |
| 2983-0-0500 | Trial, Augment, Tibial, Size 0 Lat, 5mm | In distribution |
| 2979-0-0001 | Trial, Augment, Distal Femoral, Size 1 | In distribution |
| 2971-0-1516 | Trial, Stem, Straight, 16mm x 150mm | In distribution |
| 2977-1-0003 | Sizer, Tibial Baseplate, Left, Size 3 | In distribution |
| 2983-0-1000 | Trial, Augment, Tibial, Size 0 Lat, 10mm | In distribution |
| 2977-1-0006 | Sizer, Tibial Baseplate, Left, Size 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Attune | Depuy (Ireland) | 1,385 |
| Template | Exactech, Inc. | 1,277 |
| 4WEB Medical | 4WEB Inc. | 991 |
| Evolution® | Microport Orthopedics Inc. | 966 |
| Template | Zimmer, Inc. | 792 |
| Advance® | Microport Orthopedics Inc. | 644 |
| Apex Knee System | Omni Life Science, Inc. | 635 |
| Profemur® | Microport Orthopedics Inc. | 591 |
| Link Instruments – Trial implants and size gauges | Waldemar Link GmbH & Co. KG | 549 |
| Template | Synthes Gmbh | 516 |
| Optetrak Logic | Exactech, Inc. | 512 |
| Template | Depuy Spine, Inc. | 451 |
Showing 12 of 2,940. All products under Template
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.