Pangea
Partial Articular Proximal Tibia Plate R
31manufacturers in China registered for this device type
669catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K231257 |
| Record published | 2024-03-01 |
| Record revised | 2025-11-24 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 6 to 456 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 541104 | Number of Screw Holes: 4.0 Holes | In distribution |
| 541143S | Number of Screw Holes: 13.0 Holes | In distribution |
| 540160S | Number of Screw Holes: 20.0 Holes | In distribution |
| 541532 | Length 32.0 mm | In distribution |
| 541238 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540434 | Length 72.0 mm | In distribution |
| 627814 | Length 371.0 mm | In distribution |
| 541516 | Length 16.0 mm | In distribution |
| 540306S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541069 | Number of Screw Holes: 9.0 Holes | In distribution |
| 541530S | Diameter: 3.5 Millimeter | In distribution |
| 540526 | Length 133.0 mm | In distribution |
| 541730 | Diameter: 2.7 Millimeter | In distribution |
| 541760 | Length 60.0 mm | In distribution |
| 540378S | Number of Screw Holes: 8.0 Holes | In distribution |
| 541765S | Diameter: 2.7 Millimeter | In distribution |
| 541074 | Number of Screw Holes: 14.0 Holes | In distribution |
| 540671S | Number of Screw Holes: 11.0 Holes | In distribution |
| 540312 | Number of Screw Holes: 12.0 Holes | In distribution |
| 540526S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541038 | Number of Screw Holes: 8.0 Holes | In distribution |
| 541244 | Number of Screw Holes: 14.0 Holes | In distribution |
| 541722 | Diameter: 2.7 Millimeter | In distribution |
| 540806 | Length 133.0 mm | In distribution |
| 541470 | Screw Head: 8.0 Torx | In distribution |
| 540224 | Length 124.0 mm | In distribution |
| 540510S | Length 189.0 mm | In distribution |
| 541066 | Length 116.0 mm | In distribution |
| 662385S | Length 85.0 mm | In distribution |
| 541070S | Number of Screw Holes: 10.0 Holes | In distribution |
| 541510 | Length 10.0 mm | In distribution |
| 540326S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541524S | Length 24.0 mm | In distribution |
| 541166S | Length 116.0 mm | In distribution |
| 541343S | Number of Screw Holes: 3.0 Holes | In distribution |
| 540834 | Number of Screw Holes: 4.0 Holes | In distribution |
| 541711 | Screw Head: 8.0 Torx | In distribution |
| 541560 | Length 60.0 mm | In distribution |
| 540322 | Length 95.0 mm | In distribution |
| 541709 | Diameter: 2.7 Millimeter | In distribution |
| 540308S | Number of Screw Holes: 8.0 Holes | In distribution |
| 541409S | Length 9.0 mm | In distribution |
| 540246S | Diameter: 5.0 Millimeter | In distribution |
| 541516S | Length 16.0 mm | In distribution |
| 540352 | Number of Screw Holes: 12.0 Holes | In distribution |
| 541736 | Length 36.0 mm | In distribution |
| 540106S | Number of Screw Holes: 6.0 Holes | In distribution |
| 540464S | Number of Screw Holes: 4.0 Holes | In distribution |
| 541321S | Number of Screw Holes: 5.0 Holes | In distribution |
| 540066S | Length 133.0 mm | In distribution |
| 541728S | Screw Head: 8.0 Torx | In distribution |
| 627856S | Length 396.0 mm | In distribution |
| 540810S | Number of Screw Holes: 10.0 Holes | In distribution |
| 540436S | Length 100.0 mm | In distribution |
| 541420 | Diameter: 2.7 Millimeter | In distribution |
| 541450 | Length 50.0 mm | In distribution |
| 541720 | Length 20.0 mm | In distribution |
| 541711S | Diameter: 2.7 Millimeter | In distribution |
| 541717 | Screw Head: 8.0 Torx | In distribution |
| 541035S | Diameter: 3.5 Millimeter | In distribution |
| 541444S | Length 44.0 mm | In distribution |
| 540508S | Length 161.0 mm | In distribution |
| 541514 | Screw Head: 15.0 Torx | In distribution |
| 627861 | Side: RIGHT | In distribution |
| 540146 | Number of Screw Holes: 6.0 Holes | In distribution |
| 540174S | Number of Screw Holes: 4.0 Holes | In distribution |
| 540523S | Number of Screw Holes: 3.0 Holes | In distribution |
| 541426 | Diameter: 2.7 Millimeter | In distribution |
| 541534 | Diameter: 3.5 Millimeter | In distribution |
| 540574 | Length 111.0 mm | In distribution |
| 662324S | Screw Head: 20.0 Torx | In distribution |
| 540574S | Length 111.0 mm | In distribution |
| 541345 | Length 62.0 mm | In distribution |
| 540626S | Diameter: 3.5 Millimeter | In distribution |
| 541344S | Length 50.0 mm | In distribution |
| 541536S | Length 36.0 mm | In distribution |
| 541755S | Diameter: 2.7 Millimeter | In distribution |
| 540110 | Side: LEFT | In distribution |
| 540146S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541742S | Diameter: 2.7 Millimeter | In distribution |
| 627813S | Length 320.0 mm | In distribution |
| 540266S | Diameter: 5.0 Millimeter | In distribution |
| 540466S | Number of Screw Holes: 6.0 Holes | In distribution |
| 540328S | Number of Screw Holes: 8.0 Holes | In distribution |
| 540005 | Length 119.0 mm | In distribution |
| 540012S | Number of Screw Holes: 12.0 Holes | In distribution |
| 541135 | Number of Screw Holes: 5.0 Holes | In distribution |
| 541446S | Length 46.0 mm | In distribution |
| 540254S | Diameter: 5.0 Millimeter | In distribution |
| 540418S | Number of Screw Holes: 18.0 Holes | In distribution |
| 540724 | Number of Screw Holes: 4.0 Holes | In distribution |
| 627842S | Side: LEFT | In distribution |
| 541038S | Number of Screw Holes: 8.0 Holes | In distribution |
| 627821 | Length 257.0 mm | In distribution |
| 541348S | Length 98.0 mm | In distribution |
| 541460S | Length 60.0 mm | In distribution |
| 541540 | Diameter: 3.5 Millimeter | In distribution |
| 662214S | Screw Head: 20.0 Torx | In distribution |
| 540704S | Length 81.0 mm | In distribution |
| 540334S | Number of Screw Holes: 14.0 Holes | In distribution |
| 541712S | Diameter: 2.7 Millimeter | In distribution |
| 627848 | Side: RIGHT | In distribution |
| 541712 | Diameter: 2.7 Millimeter | In distribution |
| 706433 | In distribution | |
| 627853S | Side: LEFT | In distribution |
| 541570 | Length 70.0 mm | In distribution |
| 540746 | Length 79.0 mm | In distribution |
| 662415S | Screw Head: 20.0 Torx | In distribution |
| 540464 | Length 68.0 mm | In distribution |
| 627816S | Side: LEFT | In distribution |
| 541410S | Diameter: 2.7 Millimeter | In distribution |
| 540668 | Length 137.0 mm | In distribution |
| 540514S | Length 245.0 mm | In distribution |
| 627846S | Side: RIGHT | In distribution |
| 540548S | Length 167.0 mm | In distribution |
| 541765 | Diameter: 2.7 Millimeter | In distribution |
| 541448S | Length 48.0 mm | In distribution |
| 541418S | Length 18.0 mm | In distribution |
| 540630S | Diameter: 2.7 Millimeter | In distribution |
| 540485S | Diameter: 3.5 Millimeter | In distribution |
| 540154 | Length 337.0 mm | In distribution |
| 662370 | Length 70.0 mm | In distribution |
| 541008 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540836S | Diameter: 3.5 Millimeter | In distribution |
| 540182 | Length 302.0 mm | In distribution |
| 541615S | Diameter: 3.5 Millimeter | In distribution |
| 541044 | Number of Screw Holes: 14.0 Holes | In distribution |
| 541706S | Screw Head: 8.0 Torx | In distribution |
| 541600S | Diameter: 3.5 Millimeter | In distribution |
| 541550 | Diameter: 3.5 Millimeter | In distribution |
| 541321 | Screw Head: 3.0 Torx | In distribution |
| 627849 | Side: RIGHT | In distribution |
| 541548S | Diameter: 3.5 Millimeter | In distribution |
| 541118S | Number of Screw Holes: 18.0 Holes | In distribution |
| 540647 | Length 123.0 mm | In distribution |
| 541524 | Screw Head: 15.0 Torx | In distribution |
| 541428 | Screw Head: 8.0 Torx | In distribution |
| 541750S | Length 50.0 mm | In distribution |
| 540808 | Number of Screw Holes: 8.0 Holes | In distribution |
| 541411 | Length 11.0 mm | In distribution |
| 540274S | Number of Screw Holes: 14.0 Holes | In distribution |
| 541432 | Length 32.0 mm | In distribution |
| 662232 | Diameter: 4.0 Millimeter | In distribution |
| 541446 | Length 46.0 mm | In distribution |
| 541738 | Diameter: 2.7 Millimeter | In distribution |
| 540649 | Length 151.0 mm | In distribution |
| 541720S | Diameter: 2.7 Millimeter | In distribution |
| 540648S | Length 137.0 mm | In distribution |
| 541432S | Screw Head: 8.0 Torx | In distribution |
| 540624S | Length 103.0 mm | In distribution |
| 627854 | Length 318.0 mm | In distribution |
| 541728 | Screw Head: 8.0 Torx | In distribution |
| 541734S | Length 34.0 mm | In distribution |
| 662295S | Length 95.0 mm | In distribution |
| 540308 | Number of Screw Holes: 8.0 Holes | In distribution |
| 627826S | Length 320.0 mm | In distribution |
| 540670S | Number of Screw Holes: 10.0 Holes | In distribution |
| 627823 | Side: RIGHT | In distribution |
| 541555 | Screw Head: 15.0 Torx | In distribution |
| 662265S | Screw Head: 20.0 Torx | In distribution |
| 541400 | Screw Head: 15.0 Torx | In distribution |
| 540645S | Number of Screw Holes: 5.0 Holes | In distribution |
| 541141 | Diameter: 3.5 Millimeter | In distribution |
| 662375 | Screw Head: 20.0 Torx | In distribution |
| 541112S | Length 134.0 mm | In distribution |
| 540302S | Length 95.0 mm | In distribution |
| 540602S | Length 75.0 mm | In distribution |
| 627865S | Length 355.0 mm | In distribution |
| 661214 | Screw Head: 20.0 Torx | In distribution |
| 541071 | Number of Screw Holes: 11.0 Holes | In distribution |
| 541436S | Length 36.0 mm | In distribution |
| 540622 | Diameter: 2.7 Millimeter | In distribution |
| 541073 | Number of Screw Holes: 13.0 Holes | In distribution |
| 541710S | Diameter: 2.7 Millimeter | In distribution |
| 540516S | Length 273.0 mm | In distribution |
| 541070 | Number of Screw Holes: 10.0 Holes | In distribution |
| 541522S | Length 22.0 mm | In distribution |
| 540554S | Number of Screw Holes: 14.0 Holes | In distribution |
| 706451 | Length 345.0 mm | In distribution |
| 541713S | Screw Head: 8.0 Torx | In distribution |
| 541043S | Number of Screw Holes: 13.0 Holes | In distribution |
| 662218S | Length 18.0 mm | In distribution |
| 541305S | Number of Screw Holes: 5.0 Holes | In distribution |
| 662314 | Length 14.0 mm | In distribution |
| 541078S | Length 354.0 mm | In distribution |
| 541512 | Screw Head: 15.0 Torx | In distribution |
| 541455 | Length 55.0 mm | In distribution |
| 541520S | Screw Head: 15.0 Torx | In distribution |
| 541718 | Diameter: 2.7 Millimeter | In distribution |
| 540244 | Diameter: 5.0 Millimeter | In distribution |
| 541034 | Number of Screw Holes: 4.0 Holes | In distribution |
| 540506S | Number of Screw Holes: 6.0 Holes | In distribution |
| 540295 | Number of Screw Holes: 5.0 Holes | In distribution |
| 541465 | Length 65.0 mm | In distribution |
| 541243S | Number of Screw Holes: 13.0 Holes | In distribution |
| 541722S | Length 22.0 mm | In distribution |
| 541143 | Number of Screw Holes: 13.0 Holes | In distribution |
| 540063 | Length 86.0 mm | In distribution |
| 541580 | Length 80.0 mm | In distribution |
| 540314S | Number of Screw Holes: 14.0 Holes | In distribution |
| 541526 | Screw Head: 15.0 Torx | In distribution |
| 541444 | Screw Head: 8.0 Torx | In distribution |
| 541724 | Diameter: 2.7 Millimeter | In distribution |
| 541707 | Length 7.0 mm | In distribution |
| 541114 | Number of Screw Holes: 14.0 Holes | In distribution |
| 541480S | Diameter: 2.7 Millimeter | In distribution |
| 541713 | Screw Head: 8.0 Torx | In distribution |
| 662332 | Length 32.0 mm | In distribution |
| 540576 | Length 139.0 mm | In distribution |
| 541548 | Length 48.0 mm | In distribution |
| 662336 | Screw Head: 20.0 Torx | In distribution |
| 541750 | Screw Head: 8.0 Torx | In distribution |
| 540268S | Number of Screw Holes: 8.0 Holes | In distribution |
| 541416 | Length 16.0 mm | In distribution |
| 541717S | Diameter: 2.7 Millimeter | In distribution |
| 541455S | Diameter: 2.7 Millimeter | In distribution |
| 627844S | Side: LEFT | In distribution |
| 541724S | Screw Head: 8.0 Torx | In distribution |
| 540204 | Length 124.0 mm | In distribution |
| 706436 | In distribution | |
| 541268 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540178S | Number of Screw Holes: 8.0 Holes | In distribution |
| 541550S | Screw Head: 15.0 Torx | In distribution |
| 541434S | Diameter: 2.7 Millimeter | In distribution |
| 540408 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540733S | Length 207.0 mm | In distribution |
| 541273S | Number of Screw Holes: 13.0 Holes | In distribution |
| 662322S | Length 22.0 mm | In distribution |
| 541708S | Diameter: 2.7 Millimeter | In distribution |
| 540725 | Length 95.0 mm | In distribution |
| 662316 | Screw Head: 20.0 Torx | In distribution |
| 541746 | Length 46.0 mm | In distribution |
| 540336S | Number of Screw Holes: 16.0 Holes | In distribution |
| 541138S | Length 126.0 mm | In distribution |
| 662348S | Length 48.0 mm | In distribution |
| 662338 | Length 38.0 mm | In distribution |
| 541718S | Diameter: 2.7 Millimeter | In distribution |
| 540748S | Length 94.0 mm | In distribution |
| 540108 | Side: LEFT | In distribution |
| 540512 | Length 217.0 mm | In distribution |
| 662350S | Length 50.0 mm | In distribution |
| 541534S | Diameter: 3.5 Millimeter | In distribution |
| 540506 | Length 133.0 mm | In distribution |
| 541775S | Diameter: 2.7 Millimeter | In distribution |
| 541442 | Diameter: 2.7 Millimeter | In distribution |
| 541542S | Length 42.0 mm | In distribution |
| 540226S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541071S | Length 232.0 mm | In distribution |
| 540065S | Length 119.0 mm | In distribution |
| 540326 | Number of Screw Holes: 6.0 Holes | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220319 | 2022-06-10 |
| K213199 | 2022-01-11 |
| K193366 | 2020-03-20 |
| K183104 | 2019-06-10 |
| K180500 | 2018-06-04 |
| K173135 | 2017-11-27 |
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.