Pangea
Partial Articular Proximal Tibia Plate L
22manufacturers in China registered for this device type
421catalogue numbers in this listing
25510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K231257 |
| Record published | 2023-06-13 |
| 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 10 to 486 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 627864S | Side: RIGHT | In distribution |
| 540176 | Number of Screw Holes: 6.0 Holes | In distribution |
| 627866S | Side: RIGHT | In distribution |
| 540223S | Number of Screw Holes: 3.0 Holes | In distribution |
| 541041 | Number of Screw Holes: 11.0 Holes | In distribution |
| 540184S | Number of Screw Holes: 14.0 Holes | In distribution |
| 540264S | Number of Screw Holes: 4.0 Holes | In distribution |
| 540440 | Number of Screw Holes: 10.0 Holes | In distribution |
| 540544 | Length 111.0 mm | In distribution |
| 540152 | Number of Screw Holes: 12.0 Holes | In distribution |
| 540606S | Number of Screw Holes: 6.0 Holes | In distribution |
| 540108S | Number of Screw Holes: 8.0 Holes | In distribution |
| 541039 | Number of Screw Holes: 9.0 Holes | In distribution |
| 627856 | Side: LEFT | In distribution |
| 540350S | Number of Screw Holes: 10.0 Holes | In distribution |
| 662324 | Length 24.0 mm | In distribution |
| 540543S | Length 97.0 mm | In distribution |
| 661216 | Length 16.0 mm | In distribution |
| 540669 | Length 151.0 mm | In distribution |
| 540465S | Length 82.0 mm | In distribution |
| 662330S | Length 30.0 mm | In distribution |
| 540380S | Number of Screw Holes: 10.0 Holes | In distribution |
| 662340 | Screw Head: 20.0 Torx | In distribution |
| 540844S | Number of Screw Holes: 14.0 Holes | In distribution |
| 540248S | Diameter: 5.0 Millimeter | In distribution |
| 627844 | Length 402.0 mm | In distribution |
| 540750 | Length 109.0 mm | In distribution |
| 540644 | Length 81.0 mm | In distribution |
| 541178S | Number of Screw Holes: 18.0 Holes | In distribution |
| 661210 | Diameter: 5.0 Millimeter | In distribution |
| 541072 | Number of Screw Holes: 12.0 Holes | In distribution |
| 540178 | Number of Screw Holes: 8.0 Holes | In distribution |
| 627826 | Side: RIGHT | In distribution |
| 541349 | Length 110.0 mm | In distribution |
| 540414 | Diameter: 3.5 Millimeter | In distribution |
| 541303 | Length 37.0 mm | In distribution |
| 540806S | Number of Screw Holes: 6.0 Holes | In distribution |
| 542175 | Length 356.0 mm | In distribution |
| 540384S | Number of Screw Holes: 14.0 Holes | In distribution |
| 627812S | Side: LEFT | In distribution |
| 662380S | Screw Head: 20.0 Torx | In distribution |
| 662248 | Screw Head: 20.0 Torx | In distribution |
| 540003S | Number of Screw Holes: 3.0 Holes | In distribution |
| 540582 | Number of Screw Holes: 12.0 Holes | In distribution |
| 540005S | Number of Screw Holes: 5.0 Holes | In distribution |
| 540538S | Number of Screw Holes: 18.0 Holes | In distribution |
| 662290S | Screw Head: 20.0 Torx | In distribution |
| 541114S | Diameter: 2.7 Millimeter | In distribution |
| 540006 | Number of Screw Holes: 6.0 Holes | In distribution |
| 540573S | Side: RIGHT | In distribution |
| 540283S | Number of Screw Holes: 3.0 Holes | In distribution |
| 662242 | Screw Head: 20.0 Torx | In distribution |
| 540727 | Diameter: 2.7 Millimeter | In distribution |
| 541244S | Number of Screw Holes: 14.0 Holes | In distribution |
| 540174 | Length 160.0 mm | In distribution |
| 541322S | Diameter: 2.7 Millimeter | In distribution |
| 540556S | Number of Screw Holes: 16.0 Holes | In distribution |
| 542134 | Length 331.0 mm | In distribution |
| 540444S | Length 212.0 mm | In distribution |
| 662275 | Length 75.0 mm | In distribution |
| 662230S | Length 30.0 mm | In distribution |
| 540576S | Length 139.0 mm | In distribution |
| 540330 | Number of Screw Holes: 10.0 Holes | In distribution |
| 540293 | Number of Screw Holes: 3.0 Holes | In distribution |
| 540803S | Number of Screw Holes: 3.0 Holes | In distribution |
| 540180S | Number of Screw Holes: 10.0 Holes | In distribution |
| 662326S | Diameter: 5.0 Millimeter | In distribution |
| 540792S | Number of Screw Holes: 22.0 Holes | In distribution |
| 662255 | Screw Head: 20.0 Torx | In distribution |
| 540406S | Diameter: 3.5 Millimeter | In distribution |
| 706430 | In distribution | |
| 542120 | Length 152.0 mm | In distribution |
| 662334 | Diameter: 5.0 Millimeter | In distribution |
| 540295S | Number of Screw Holes: 5.0 Holes | In distribution |
| 541072S | Length 249.0 mm | In distribution |
| 541148S | Number of Screw Holes: 18.0 Holes | In distribution |
| 542171 | Length 138.0 mm | In distribution |
| 540528 | Number of Screw Holes: 8.0 Holes | In distribution |
| 662280S | Screw Head: 20.0 Torx | In distribution |
| 540202 | Length 96.0 mm | In distribution |
| 540785 | Length 147.0 mm | In distribution |
| 540782S | Length 125.0 mm | In distribution |
| 540330S | Number of Screw Holes: 10.0 Holes | In distribution |
| 540468S | Length 124.0 mm | In distribution |
| 541106 | Number of Screw Holes: 6.0 Holes | In distribution |
| 6497-5-010 | Side: LEFT | In distribution |
| 540650S | Length 165.0 mm | In distribution |
| 540450S | Number of Screw Holes: 20.0 Holes | In distribution |
| 540012 | Number of Screw Holes: 12.0 Holes | In distribution |
| 542153 | Length 204.0 mm | In distribution |
| 6497-2-050S | Length 240.0 mm | In distribution |
| 662410S | Length 110.0 mm | In distribution |
| 540264 | Length 151.0 mm | In distribution |
| 662370S | Screw Head: 20.0 Torx | In distribution |
| 540422S | Diameter: 3.5 Millimeter | In distribution |
| 540348 | Number of Screw Holes: 8.0 Holes | In distribution |
| 662360S | Diameter: 5.0 Millimeter | In distribution |
| 540646S | Length 109.0 mm | In distribution |
| 541250S | Length 270.0 mm | In distribution |
| 541273 | Number of Screw Holes: 13.0 Holes | In distribution |
| 541006 | Diameter: 2.7 Millimeter | In distribution |
| 540782 | Diameter: 2.7 Millimeter | In distribution |
| 541174 | Length 294.0 mm | In distribution |
| 662295 | Diameter: 4.0 Millimeter | In distribution |
| 540324 | Number of Screw Holes: 4.0 Holes | In distribution |
| 627854S | Side: LEFT | In distribution |
| 627846 | Length 334.0 mm | In distribution |
| 540552 | Number of Screw Holes: 12.0 Holes | In distribution |
| 541144S | Length 228.0 mm | In distribution |
| 662240S | Screw Head: 20.0 Torx | In distribution |
| 540114 | Number of Screw Holes: 14.0 Holes | In distribution |
| 541110 | Number of Screw Holes: 10.0 Holes | In distribution |
| 662285S | Diameter: 4.0 Millimeter | In distribution |
| 540602 | Length 75.0 mm | In distribution |
| 540304 | Number of Screw Holes: 4.0 Holes | In distribution |
| 541067S | Number of Screw Holes: 7.0 Holes | In distribution |
| 541343 | Length 38.0 mm | In distribution |
| 540648 | Length 137.0 mm | In distribution |
| 627824S | Side: RIGHT | In distribution |
| 540472S | Number of Screw Holes: 12.0 Holes | In distribution |
| 541271S | Length 232.0 mm | In distribution |
| 662322 | Screw Head: 20.0 Torx | In distribution |
| 541167S | Diameter: 5.0 Millimeter | In distribution |
| 540322S | Number of Screw Holes: 2.0 Holes | In distribution |
| 540152S | Number of Screw Holes: 12.0 Holes | In distribution |
| 540378 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540665 | Length 95.0 mm | In distribution |
| 540285 | Length 113.0 mm | In distribution |
| 541139S | Length 147.0 mm | In distribution |
| 541303S | Length 37.0 mm | In distribution |
| 6497-6-010S | Side: RIGHT | In distribution |
| 541238S | Length 115.0 mm | In distribution |
| 6497-1-040 | Side: LEFT | In distribution |
| 541347 | Number of Screw Holes: 7.0 Holes | In distribution |
| 541043 | Number of Screw Holes: 13.0 Holes | In distribution |
| 540503 | Length 91.0 mm | In distribution |
| 540182S | Number of Screw Holes: 12.0 Holes | In distribution |
| 540810 | Diameter: 3.5 Millimeter | In distribution |
| 541082S | Length 414.0 mm | In distribution |
| 540812 | Length 217.0 mm | In distribution |
| 662228 | Length 28.0 mm | In distribution |
| 541239S | Number of Screw Holes: 9.0 Holes | In distribution |
| 541004 | Number of Screw Holes: 4.0 Holes | In distribution |
| 627861S | Length 173.0 mm | In distribution |
| 662226S | Length 26.0 mm | In distribution |
| 706437 | In distribution | |
| 540650 | Length 165.0 mm | In distribution |
| 542185 | Length 95.0 mm | In distribution |
| 540286 | Number of Screw Holes: 6.0 Holes | In distribution |
| 540546S | Length 139.0 mm | In distribution |
| 541168 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540705S | Side: LEFT | In distribution |
| 540438 | Diameter: 3.5 Millimeter | In distribution |
| 541348 | Length 98.0 mm | In distribution |
| 627847 | Length 358.0 mm | In distribution |
| 541037S | Number of Screw Holes: 7.0 Holes | In distribution |
| 6497-2-030S | Thickness: 5.0 Millimeter | In distribution |
| 627853 | Length 280.0 mm | In distribution |
| 542115 | Length 60.0 mm | In distribution |
| 540006S | Length 133.0 mm | In distribution |
| 541006S | Diameter: 2.7 Millimeter | In distribution |
| 662348 | Diameter: 5.0 Millimeter | In distribution |
| 6497-1-050 | Side: LEFT | In distribution |
| 661212S | Length 12.0 mm | In distribution |
| 540675S | Length 235.0 mm | In distribution |
| 540104 | Number of Screw Holes: 4.0 Holes | In distribution |
| 541065S | Number of Screw Holes: 5.0 Holes | In distribution |
| 540296 | Length 127.0 mm | In distribution |
| 540328 | Number of Screw Holes: 8.0 Holes | In distribution |
| 541132S | Diameter: 3.5 Millimeter | In distribution |
| 540184 | Length 337.0 mm | In distribution |
| 541241S | Length 172.0 mm | In distribution |
| 540410 | Number of Screw Holes: 10.0 Holes | In distribution |
| 540442 | Number of Screw Holes: 12.0 Holes | In distribution |
| 540188S | Number of Screw Holes: 18.0 Holes | In distribution |
| 627851 | Side: LEFT | In distribution |
| 541069S | Diameter: 5.0 Millimeter | In distribution |
| 541144 | Number of Screw Holes: 14.0 Holes | In distribution |
| 540536S | Length 273.0 mm | In distribution |
| 541345S | Diameter: 3.5 Millimeter | In distribution |
| 540573 | Length 97.0 mm | In distribution |
| 627841 | Side: LEFT | In distribution |
| 540114S | Number of Screw Holes: 14.0 Holes | In distribution |
| 541274 | Number of Screw Holes: 14.0 Holes | In distribution |
| 540649S | Length 151.0 mm | In distribution |
| 541020 | Length 152.0 mm | In distribution |
| 540112 | Side: LEFT | In distribution |
| 541152S | Number of Screw Holes: 22.0 Holes | In distribution |
| 540780 | Length 109.0 mm | In distribution |
| 540580 | Number of Screw Holes: 10.0 Holes | In distribution |
| 662340S | Diameter: 5.0 Millimeter | In distribution |
| 540442S | Number of Screw Holes: 12.0 Holes | In distribution |
| 540068 | Length 161.0 mm | In distribution |
| 6497-1-050S | Thickness: 5.0 Millimeter | In distribution |
| 540435 | Length 86.0 mm | In distribution |
| 542172 | Length 138.0 mm | In distribution |
| 662222S | Length 22.0 mm | In distribution |
| 541315 | Length 79.0 mm | In distribution |
| 540412S | Number of Screw Holes: 12.0 Holes | In distribution |
| 627811S | Side: LEFT | In distribution |
| 540752S | Number of Screw Holes: 12.0 Holes | In distribution |
| 627811 | Side: LEFT | In distribution |
| 540532 | Number of Screw Holes: 12.0 Holes | In distribution |
| 662380 | Diameter: 5.0 Millimeter | In distribution |
| 540504 | Number of Screw Holes: 4.0 Holes | In distribution |
| 540484S | Number of Screw Holes: 4.0 Holes | In distribution |
| 541342S | Number of Screw Holes: 2.0 Holes | In distribution |
| 662248S | Screw Head: 20.0 Torx | In distribution |
| 540708S | Length 137.0 mm | In distribution |
| 540324S | Length 123.0 mm | In distribution |
| 662246 | Screw Head: 20.0 Torx | In distribution |
| 662328S | Diameter: 5.0 Millimeter | In distribution |
| 540546 | Length 139.0 mm | In distribution |
| 540144S | Number of Screw Holes: 4.0 Holes | In distribution |
| 662350 | Diameter: 5.0 Millimeter | In distribution |
| 540812S | Diameter: 3.5 Millimeter | In distribution |
| 540314 | Number of Screw Holes: 14.0 Holes | In distribution |
| 540523 | Number of Screw Holes: 3.0 Holes | In distribution |
| 540803 | Length 86.0 mm | In distribution |
| 541110S | Number of Screw Holes: 10.0 Holes | In distribution |
| 540704 | Diameter: 2.7 Millimeter | In distribution |
| 540711S | Side: LEFT | In distribution |
| 627866 | Length 396.0 mm | In distribution |
| 540466 | Number of Screw Holes: 6.0 Holes | In distribution |
| 6497-5-010S | Side: RIGHT | In distribution |
| 662226 | Length 26.0 mm | In distribution |
| 627843 | Length 379.0 mm | In distribution |
| 627855S | Side: LEFT | In distribution |
| 540796S | Number of Screw Holes: 26.0 Holes | In distribution |
| 662420S | Diameter: 5.0 Millimeter | In distribution |
| 662270S | Screw Head: 20.0 Torx | In distribution |
| 540180 | Number of Screw Holes: 10.0 Holes | In distribution |
| 662236 | Diameter: 4.0 Millimeter | In distribution |
| 662355 | Diameter: 5.0 Millimeter | In distribution |
| 627849S | Length 402.0 mm | In distribution |
| 540356S | Number of Screw Holes: 16.0 Holes | In distribution |
| 540728S | Length 137.0 mm | In distribution |
| 540376S | Number of Screw Holes: 6.0 Holes | In distribution |
| 541064 | Number of Screw Holes: 4.0 Holes | In distribution |
| 662270 | Diameter: 4.0 Millimeter | In distribution |
| 540285S | Number of Screw Holes: 4.0 Holes | In distribution |
| 540664S | Length 81.0 mm | In distribution |
| 662375S | Length 75.0 mm | In distribution |
| 540838 | Number of Screw Holes: 8.0 Holes | In distribution |
| 540008S | Length 161.0 mm | In distribution |
| 540018S | Length 301.0 mm | In distribution |
| 662330 | Screw Head: 20.0 Torx | In distribution |
| 541248S | Length 252.0 mm | In distribution |
| 540755S | Length 147.0 mm | In distribution |
| 540448S | Number of Screw Holes: 18.0 Holes | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242445 | 2024-10-06 |
| K233919 | 2024-03-25 |
| K231257 | 2023-08-18 |
| K231262 | 2023-08-18 |
| K222381 | 2023-04-27 |
| K223772 | 2023-04-07 |
| K221346 | 2022-07-08 |
| K212581 | 2022-01-19 |
| K200398 | 2020-06-05 |
| K192675 | 2019-11-22 |
| K191412 | 2019-08-23 |
| K183172 | 2019-03-05 |
| K181091 | 2018-10-11 |
| K172148 | 2018-03-19 |
| K172350 | 2017-12-15 |
| K170727 | 2017-06-22 |
| K170771 | 2017-05-08 |
| K162841 | 2017-02-21 |
| K162439 | 2017-02-03 |
| K153379 | 2016-05-26 |
| K151769 | 2015-10-27 |
| K151879 | 2015-08-06 |
| K113109 | 2011-12-23 |
| K112926 | 2011-12-19 |
| K110476 | 2011-03-18 |
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 |
|---|---|---|---|---|---|
| 2019-12-05 | Class II | Under Investigation by firm | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | 433 (289 units U.S. / 144 units OUS) | 2020-10-09 |
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.