Integra® Proximal Humeral Fracture Plate System
Integra Proximal Humeral Fracture Plate System provides left- and right-sided plates for reconstruction of the upper humerus. GT plates cover the greater tuberosity, while LP plates sit…
Integra Proximal Humeral Fracture Plate System provides left- and right-sided plates for reconstruction of the upper humerus. GT plates cover the greater tuberosity, while LP plates sit lower on that region.
GT plates have four-, seven- or ten-hole configurations; LP plates have three, six or nine holes. The plate and screw components use 316L stainless steel.
Listed Item
The Integra Proximal Humeral Fracture Plate System will be composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The plates and screws are made of 316L Stainless Steel. The GT plate is designed to cover the greater tuberosity and is available in four-hole, seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system will also feature 3.5mm locking screws, non-locking compression screws and non-locking partial thread screws. In addition 2.7mm locking screws are also available. The system is indicated for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Instruments are provided to assist with the implants.
Screws and Fixation
The system includes 3.5 mm locking, nonlocking and lag screws, plus 2.7 mm locking screws. It is intended for proximal-humeral fractures and fracture-dislocations, osteotomies and nonunions, with plate selection matched to the reconstruction.
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 | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K121826 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS3532CS | 1.380 in L x.138 in dia | In distribution |
| PSS3550PS | 2.069 in L x.138 in dia;.709 in thread | In distribution |
| HFP0930307LS | 4.512 mm L | In distribution |
| PSS3570PS | 2.856 in L x.138 in dia;.985 in thread | In distribution |
| PSS3522LS | .994 in L x.138 in dia | In distribution |
| PSS3530LS | 1.289 in L x.138 in dia | In distribution |
| HFP0930304RS | 3.574 mm L | In distribution |
| PSS3517LS | .797 in L x.138 in dia | In distribution |
| HFP0930109LS | 5.342 mm L | In distribution |
| PSS3555PS | 2.265 in L x.138 in dia;.780 in thread | In distribution |
| PSS3565LS | 2.667 in L x.138 in dia | In distribution |
| PSS3550LS | 2.077 in L x.138 in dia | In distribution |
| PSS3522CS | .986 in L x.138 in dia | In distribution |
| PSS3540LS | 1.683 in L x.138 in dia | In distribution |
| PSS3530CS | 1.281 in L x.138 in dia | In distribution |
| PSS2720LS | .929 in L x.106 in dia | In distribution |
| HFP0930310RS | 5.450 mm L | In distribution |
| PSS3532LS | 1.388 in L x.138 in dia | In distribution |
| PSS2722LS | 1.028 in L x.106 in dia | In distribution |
| PSS3515CS | .691 in L x.138 in dia | In distribution |
| PSS3520LS | .895 in L x.138 in dia | In distribution |
| PSS2725LS | 1.126 in L x.106 in dia | In distribution |
| PSS3527CS | 1.183 in L x.138 in dia | In distribution |
| PSS3545PS | 1.872 in L x.138 in dia;.640 in thread | In distribution |
| HFP0930106RS | 4.405 mm L | In distribution |
| PSS3575LS | 3.061 in L x.138 in dia | In distribution |
| HFP0930310LS | 5.450 mm L | In distribution |
| PSS3575PS | 3.053 in L x.138 in dia; 1.057 in thread | In distribution |
| PSS3540PS | 1.675 in L x.138 in dia;.571 in thread | In distribution |
| PSS3560PS | 2.462 in L x.138 in dia;.847 in thread | In distribution |
| PSS2717LS | .800 in L x.106 in dia | In distribution |
| PSS2712LS | .634 in L x.106 in dia | In distribution |
| PSS3525CS | 1.084 in L x.138 in dia | In distribution |
| PSS3517CS | .789 in L x.138 in dia | In distribution |
| PSS3515LS | .699 in L x.138 in dia | In distribution |
| HFP0930106LS | 4.405 mm L | In distribution |
| HFP0930103RS | 3.467 mm L | In distribution |
| PSS2715LS | .733 in L x.106 in dia | In distribution |
| HFP0930304LS | 3.574 mm L | In distribution |
| PSS3540CS | 1.675 in L x.138 in dia | In distribution |
| HFP0930109RS | 5.342 mm L | In distribution |
| HFP0930307RS | 4.512 mm L | In distribution |
| PSS3535LS | 1.486 in L x.138 in dia | In distribution |
| HFP0930103LS | 3.467 mm L | In distribution |
| PSS3535CS | 1.478 in L x.138 in dia | In distribution |
| PSS3520CS | .887 in L x.138 in dia | In distribution |
| PSS3560LS | 2.470 in L x.138 in dia | In distribution |
| PSS2710LS | .536 in L x.106 in dia | In distribution |
| PSS3537LS | 1.584 in L x.138 in dia | In distribution |
| PSS3570LS | 2.864 in L x.138 in dia | In distribution |
| PSS3525LS | 1.092 in L x.138 in dia | In distribution |
| PSS3527LS | 1.191 in L x.138 in dia | In distribution |
| PSS3545LS | 1.880 in L x.138 in dia | In distribution |
| PSS3565PS | 2.659 in L x.138 in dia;.916 in thread | In distribution |
| PSS3555LS | 2.273 in L x.138 in dia | In distribution |
| PSS3537CS | 1.576 in L x.138 in dia | In distribution |
| HFPLATEIMP | Withdrawn |
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 |
|---|---|
| K121826 | 2013-02-13 |
| K110700 | 2011-12-06 |
| K100502 | 2010-08-02 |
| K100176 | 2010-06-16 |
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.