A.l.p.s.® Proximal Humerus Plating System
67 catalogue numbers from 110025444, listed by Biomet Orthopedics, United States, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
67catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K143697 |
| Record published | 2021-08-06 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110025444 | 44 mm | In distribution |
| 110025430 | 30 mm | In distribution |
| 110030408 | 11 Hole 197 mm | In distribution |
| 110030307 | 7 Hole 140 mm | In distribution |
| 110030308 | 11 Hole 197 mm | In distribution |
| 110025354 | 54 MM | In distribution |
| 110030406 | 4 Hole 90 mm | In distribution |
| 110030306 | 4 Hole 90 mm | In distribution |
| 110025336 | 36 MM | In distribution |
| 110025330 | 30 MM | In distribution |
| 110025332 | 32 MM | In distribution |
| 110025346 | 46 MM | In distribution |
| 110025352 | 52 MM | In distribution |
| 110025342 | 42 MM | In distribution |
| 110025360 | 60 MM | In distribution |
| 110025334 | 34 MM | In distribution |
| 110025370 | 70 MM | In distribution |
| 110025358 | 58 MM | In distribution |
| 110025420 | 20 mm | In distribution |
| 110025448 | 48 mm | In distribution |
| 110025438 | 38 mm | In distribution |
| 110025426 | 26 mm | In distribution |
| 110025322 | 22 MM | In distribution |
| 110030407 | 7 Hole 140 mm | In distribution |
| 110025465 | 65 mm | In distribution |
| 110030409 | 14 Hole 234 mm | In distribution |
| 110025470 | 70 mm | In distribution |
| 110025365 | 65 MM | In distribution |
| 110025324 | 24 MM | In distribution |
| 110030109 | 14 Hole 227 mm | In distribution |
| 110030305 | 3 Hole 80 mm | In distribution |
| 110025320 | 20 MM | In distribution |
| 110025432 | 32 mm | In distribution |
| 110030108 | 11 Hole 190 mm | In distribution |
| 110025348 | 48 MM | In distribution |
| 110030107 | 7 Hole 133 mm | In distribution |
| 110025440 | 40 mm | In distribution |
| 110025340 | 40 MM | In distribution |
| 110025424 | 24 mm | In distribution |
| 110030205 | 3 Hole 73 mm | In distribution |
| 110025422 | 22 mm | In distribution |
| 110025350 | 50 MM | In distribution |
| 110030209 | 14 Hole 227 mm | In distribution |
| 110025458 | 58 mm | In distribution |
| 110025452 | 52 mm | In distribution |
| 110025428 | 28 mm | In distribution |
| 110030208 | 11 Hole 190 mm | In distribution |
| 110030405 | 3 Hole 80 mm | In distribution |
| 110025328 | 28 MM | In distribution |
| 110025344 | 44 MM | In distribution |
| 110025454 | 54 mm | In distribution |
| 110025326 | 26 MM | In distribution |
| 110025356 | 56 MM | In distribution |
| 110030105 | 3 Hole 73 mm | In distribution |
| 110030206 | 4 Hole 83 mm | In distribution |
| 110025456 | 56 mm | In distribution |
| 110025442 | 42 mm | In distribution |
| 110025436 | 36 mm | In distribution |
| 110025450 | 50 mm | In distribution |
| 110030106 | 4 Hole 83 mm | In distribution |
| 110025472 | 140 mm | In distribution |
| 110025338 | 38 MM | In distribution |
| 110025446 | 46 mm | In distribution |
| 110025434 | 34 mm | In distribution |
| 110030207 | 7 Hole 133 mm | In distribution |
| 110025460 | 60 mm | In distribution |
| 110030309 | 14 Hole 234 mm | In distribution |
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 |
|---|---|
| K243761 | 2025-02-19 |
| K022515 | 2002-09-17 |
| K020221 | 2002-04-02 |
| K013657 | 2001-12-03 |
Recalls Naming This Product
18 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 5 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 3 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 3 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 15 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 15 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 78 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 78 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 48 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 US and 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 16 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 US and 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 US | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 1 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 2 OUS | 2021-04-08 |
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.