(128 days)
No
The document describes a mechanical bone plate and screw fixation system and its intended uses. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests for mechanical properties.
Yes
The device is described as an "Internal Locking Plate and Screw Fixation System" intended for temporary fixation, correction of bones, and treatment of fractures, malunions, and osteotomies. These functions directly address health conditions and alter the structure or function of the body, classifying it as a therapeutic device.
No
This device is described as an "Internal Locking Plate and Screw Fixation System" intended for "temporary fixation, correction or bones in various anatomical regions." It is a surgical implant used to stabilize fractures and treat bone deformities, not to diagnose medical conditions.
No
The device description clearly outlines physical components (plates and screws) made of materials intended for surgical implantation. It describes their design, size, and function in bone fixation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary fixation, correction or bones in various anatomical regions." This describes a surgical implant used to stabilize bone fractures and deformities.
- Device Description: The device description details bone plates and screws, which are physical implants used in orthopedic surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical implant.
- Performance Studies: The performance studies listed are related to the mechanical properties and sterilization of the bone plates and screws, not diagnostic performance metrics like sensitivity or specificity.
- Predicate Devices: The predicate devices listed are also bone fixation systems, not IVDs.
Therefore, the Internal Locking Plate and Screw Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or bones in various anatomical regions.
3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, and osteotomies of the clavice. LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. 3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. 2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. 5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including; supracondylar, intra-articular and extra-aticular condylar, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur. 3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonumions and malunions of the medial proximal tibia and tibia shaft. 3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone. 2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. 2.0mm LCP condylar Plate is indicated for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.
The subject device has the identical intended use as the predicate device with only minor differences for the 3.5mm Round Hole Reconstruction Locking Plate indication, which is included in the predicate device's indication scope.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Internal Locking Plate and Screw Fixation System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The Internal Locking Bone Plate and Screw Fixation System is divided into four types: large, small, mini, and reconstruction. The length of the plate varies from 45 to 316mm, and hole number from 3 to 22 holes.
Geasure Internal Locking Bone Screw System is used either to fasten plates or similar devices onto bones or to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. There are two styles: locking screw, cortex or cancellous screw. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 2.0 to 6.5mm, total length from 6 to 120mm.
Internal Locking Plate and Screw Fixation System is a construct in which the screws are locked in the plate. The heads of the locking screws contain male threads while the holes in the plates contain female thread, this allows the screw head to be threaded into the plate. Various plate designs are available depending on specific anatomic locations, these may be larger or smaller, thicker or thinner as appropriate to various anatomic sites and the loads to which they will be subjected. The holes in the plate are designed for locking screws, or locking and non-locking screws combination to facilitate dynamic compression. By combining locking screw holes with compression screw slots in the shaft, the plate can be used as both a locking device and a fracture compression device. Internal Locking plate and screw Fixation systems do not disrupt the underlying cortical bone perfusion as much as conventional plates, which compress the plate to the cortical bone.
Materials: Titanium alloy (Ti-6Al-4V) ELI
Patient Contact: Bone and surrounding tissue
Contact Duration: Permanent (>30 days)
Sterilization Method: The devices are provided non-sterile; validated manual cleaning and steam sterilization instructions are provided for the end user before implantation.
Environment of Use: Healthcare facility/Hospital
Single Use: Yes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, Proximal humerus, Distal humerus, Distal radius, Small bones (hand, wrist, foot, ankle), Distal femur, Medial proximal tibia, Tibia shaft, Distal tibia, Distal fibula, Pelvis.
Indicated Patient Age Range
Adult patients (for 3.5mm Round Hole Reconstruction Locking Plate). Patient age range for other devices not specified.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance-bench test including:
Single Cycle Bend Testing for bone plate per ASTM F382-17
Fatigue Property Testing for bone plate per ASTM F382-17
Torsional Properties Test for the screws per ASTM F543-17
Driving Torque Test for the screws per ASTM F543-17
Axial Pullout Strength Test for the screws per ASTM F543-17
Self-Tapping Performance Test for the screws per ASTM F543-17
Reprocessing and sterilization validation testing per FDA guidance document, AAMI TIR12: 2010, AAMI TIR30: 2011/(R)2016, ISO 17665-1:2006, ISO 17665-2:2009, ISO 19227:2018.
No animal study data is submitted in this 510(k).
No clinical study data is submitted in this 510(k).
The non-clinical data demonstrates the Internal Locking Plate and Screw Fixation System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K063049, K073186, K011815, K033995, K083694, K062564, K032269, K092812, K083213, K082807
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
December 15, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd % Xiaoqing Xue Registration Engineer Sinow Medical AS Høyteknologisenteret, Thormøhlens Gate 55 Bergen, 5008 Norway
Re: K232394
Trade/Device Name: Internal Locking Plate and Screw Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 13, 2023 Received: November 13, 2023
Dear Xiaoqing Xue:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
K232394 - Xiaoqing Xue
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232394
Device Name
Internal Locking Plate and Screw Fixation System
Indications for Use (Describe)
Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or bones in various anatomical regions.
3.5mm LCP Clavicle Plate
3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, and osteotomies of the clavice.
3.5mm LCP Proximal Humeral Plate
LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
3.5mm LCP Distal Humerus plate
3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
2.4mm LCP Volar Distal Radius Plate
2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
5.0mm LCP Distal Femur Plate
5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including; supracondylar, intra-articular and extra-aticular condylar, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
3.5mm LCP Medial Proximal Tibial Plate
3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, splittype fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonumions and malunions of the medial proximal tibia and tibia shaft.
3.5mm LCP Anterolateral Distal Tibia Plate
3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.
2.7mm/3.5mm LCP Distal Fibula Plate
2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
2.0mm LCP Condylar Plate
2.0mm LCP condylar Plate is indicated for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
3
3.5mm Round Hole Reconstruction Locking Plate
The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
K232394
| Preparation Date: | Dec. 09, 2023 | |
|---|---|---|
| Submitter | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | |
| No. 12, Jinfeng Road, West Taihu Science and Technology Industrial | ||
| Park, Changzhou, Jiangsu, P.R. China | ||
| Contact | Jing Huang, Management Representative | |
| Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | ||
| No. 12, Jinfeng Road, West Taihu Science and Technology Industrial | ||
| Park, Changzhou, Jiangsu, P.R. China | ||
| Postcode: 213149 | ||
| Email: huangjing@geasure.com | ||
| Phone:+86 13656146897 | ||
| Designated | ||
| Submission | ||
| Correspondent | Company: Sinow Medical AS | |
| Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway | ||
| Contact Person: Xiaoqing Xue | ||
| Telephone: +86 15161196032 | ||
| Email: xue@bergemed.com | ||
| Subject Device | Trade name | Internal Locking Plate and Screw Fixation System |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3030, 21 CFR 888.3040 | |
| Classification Panel | Orthopedic | |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories; | |
| Smooth or threaded metallic bone fixation fastener; | ||
| Product Codes | HRS, HWC | |
| Common name for | ||
| product codes | HRS:Plate Fixation, Bone | |
| HWC: Screw, Fixation, Bone | ||
| Manufacturer | DePuy Synthes | |
| Primary Predicate | ||
| Device | Trade name | Synthes (USA) Modular Mini Fragment LCP System; |
| 510(K) number | K063049 | |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3030, 21 CFR 888.3040 | |
| Classification Panel | Orthopedic | |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories; | |
| Smooth or threaded metallic bone fixation fastener; | ||
| Product Codes | HRS, HWC | |
| Common name for | HRS:Plate Fixation, Bone | |
| Additional Predicate | ||
| Devices | product codes | HWC: Screw, Fixation, Bone |
| Manufacturer | DePuy Synthes | |
| K073186, Synthes 3.5mm LCP Clavicle Plate | ||
| System; | ||
| K011815, Synthes LCP Proximal Humerus Plate; | ||
| K033995, 3.5mm LCP Distal Humerus System; | ||
| K083694, Synthes 2.4mm VA-LCP | ||
| Two-Column Volar Distal Radius Plate; | ||
| Trade name /510(K) | ||
| number | K062564, Synthes LCP Distal Femur Plate; | |
| K032269, Synthes (USA) 3.5/4.5mm LCP | ||
| Medial Proximal Tibia Plates; | ||
| K092812, Synthes (USA) 2.7mm /3.5mm LCP | ||
| Anterolateral Distal Tibia Plates; | ||
| K083213, Synthes 2.7mm/3.5mm LCP Distal | ||
| Fibula Plates-Modification; | ||
| K082807, Synthes (USA) 3.5 mm and 4.5 mm | ||
| Locking Compression Plate (LCP) System with | ||
| Expanded Indications | ||
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3030, 21 CFR 888.3040 | |
| Product Codes | HRS, HWC | |
| Classification Panel | Orthopedic | |
| Classification Name | Single/multiple component metallic bone fixation | |
| appliances and accessories; | ||
| Smooth or threaded metallic bone fixation | ||
| fastener; | ||
| Reference device | Manufacturer | Changzhou Geasure Medical Apparatus and |
| Instruments Co., Ltd | ||
| Trade name | Spinal Inner Fixation System | |
| 510(K) number | K222031 | |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3070 | |
| Product Codes | NKB | |
| Classification Panel | Orthopedic | |
| Classification Name | Thoracolumbosacral Pedicle Screw system | |
| Intended | ||
| use/indications for | ||
| use | Internal Locking Plate and Screw Fixation System is intended for | |
| temporary fixation, correction or stabilization of bones in various | ||
| anatomical regions. | ||
| 3.5mm LCP Clavicle Plate | ||
| 3.5mm LCP Clavicle Plate is indicated for fixation of fractures, | ||
| malunions, non-unions, and osteotomies of the clavicle. | ||
| 3.5mm LCP Proximal Humeral Plate | ||
| LCP Proximal Humerus Plate is indicated for fractures and fracture | ||
| 3.5mm LCP Distal Humerus plate | ||
| 3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures | ||
| of the distal humerus, comminuted supracondylar fractures, | ||
| osteotomies, and non-unions of the distal humerus. | ||
| 2.4mm LCP Volar Distal Radius Plate | ||
| 2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of | ||
| complex intra- and extra-articular fractures and osteotomies of the distal | ||
| radius and other small bones. | ||
| 5.0mm LCP Distal Femur Plate | ||
| 5.0 LCP Distal Femur Plate is indicated for buttressing | ||
| multifragmentary distal femur fractures including: supracondylar, | ||
| intra-articular and extra-articular condylar, periprosthetic fractures and | ||
| fractures in normal or osteopenic bone, nonunions and malunions, and | ||
| osteotomies of the femur. | ||
| 3.5mm LCP Medial Proximal Tibial Plate | ||
| 3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress | ||
| metaphyseal fractures of the medial tibia plateau, split-type fractures of | ||
| the medial tibia plateau, medial split fractures with associated | ||
| depressions and split or depression fractures of the medial tibia plateau. | ||
| Also, for use in the fixation of osteopenic bone and fixation of | ||
| nonunions and malunions of the medial proximal tibia and tibia shaft. | ||
| 3.5mm LCP Anterolateral Distal Tibia Plate | ||
| 3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, | ||
| osteotomies, and non-unions of the distal tibia, especially in osteopenic | ||
| bone. | ||
| 2.7mm/3.5mm LCP Distal Fibula Plate | ||
| 2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, | ||
| osteotomies, and non-unions of the metaphyseal and diaphyseal region | ||
| of the distal fibula, especially in osteopenic bone. | ||
| 2.0mm LCP Condylar Plate | ||
| 2.0mm LCP condylar Plate is indicated for fixation of fractures, | ||
| osteotomies, nonunions, replantations, and fusions of small bones and | ||
| small bone fragments, particularly in osteopenic bone. Examples | ||
| include, but are not limited to, the hand, wrist, foot, and ankle. | ||
| 3.5mm Round Hole Reconstruction Locking Plate | ||
| The 3.5mm Round Hole Reconstruction Locking Plate is indicated for | ||
| fixation of fractures, osteotomies and non-unions of the pelvis, | ||
| particularly in osteopenic bone for adult patients. | ||
| Device Description | Internal Locking Plate and Screw Fixation System consists of plates in | |
| various designs and size. Plates are provided in straight designs and | ||
| Mechanism of | ||
| Action | various geometric configurations that are commonly used in traumatic | |
| and reconstructive surgery. Plates are provided with screw holes to | ||
| accommodate non-locking and locking screws. They are named | ||
| according to both anatomical positions and biomechanical functions of | ||
| the plates. The Internal Locking Bone Plate and Screw Fixation System | ||
| is divided into four types: large, small, mini, and reconstruction. The | ||
| length of the plate varies from 45 to 316mm, and hole number from 3 to | ||
| 22 holes. | ||
| Geasure Internal Locking Bone Screw System is used either to fasten | ||
| plates or similar devices onto bones or to hold bone fragments together. | ||
| The screws are differentiated by the manner in which they are inserted | ||
| into bone, their function, their size, and the type of bone they are | ||
| intended for. There are two styles: locking screw, cortex or cancellous | ||
| screw. The screw recess is hexagon or star shaped to allow screw | ||
| removal and insertion. The thread diameter of screw varies from 2.0 to | ||
| 6.5mm, total length from 6 to 120mm. | ||
| Internal Locking Plate and Screw Fixation System is a construct in | ||
| which the screws are locked in the plate. The heads of the locking | ||
| screws contain male threads while the holes in the plates contain female | ||
| thread, this allows the screw head to be threaded into the plate. Various | ||
| plate designs are available depending on specific anatomic locations, | ||
| these may be larger or smaller, thicker or thinner as appropriate to | ||
| various anatomic sites and the loads to which they will be subjected. | ||
| The holes in the plate are designed for locking screws, or locking and | ||
| non-locking screws combination to facilitate dynamic compression. By | ||
| combining locking screw holes with compression screw slots in the | ||
| shaft, the plate can be used as both a locking device and a fracture | ||
| compression device. Internal Locking plate and screw Fixation systems | ||
| do not disrupt the underlying cortical bone perfusion as much as | ||
| conventional plates, which compress the plate to the cortical bone. | ||
| Materials | Titanium alloy (Ti-6Al-4V) ELI | |
| Patient Contact | Bone and surrounding tissue | |
| Contact Duration | Permanent (>30 days) | |
| Sterilization Method | The devices are provided non-sterile; validated manual cleaning and | |
| steam sterilization instructions are provided for the end user before | ||
| implantation. | ||
| Environment of Use | Healthcare facility/Hospital | |
| Single Use | Yes | |
| Summary of | ||
| intended use and | ||
| technological | ||
| characteristics | The Internal Locking plate and Screw Fixation System is substantially | |
| equivalent to the predicate device when evaluating intended use and | ||
| technological characteristics. | ||
| The subject device has the identical intended use as the predicate device | ||
| with only minor differences for the 3.5mm Round Hole Reconstruction | ||
| Locking Plate indication, which is included in the predicate device's | ||
| indication scope. | ||
| The subject device and predicate devices are substantially equivalent | ||
| with only minor differences in technological characteristics regarding: | ||
| • Sterilization method | ||
| • device material | ||
| • Screw size | ||
| These differences do not raise new questions of safety and effectiveness. | ||
| • Performance-bench test including: | ||
| Single Cycle Bend Testing for bone plate per ASTM F382-17 | ||
| Fatigue Property Testing for bone plate per ASTM F382-17 |
Torsional Properties Test for the screws per ASTM F543-17
Driving Torque Test for the screws per ASTM F543-17
Axial Pullout Strength Test for the screws per ASTM F543-17
Self-Tapping Performance Test for the screws per ASTM F543-17 | |
| | •Reprocessing and sterilization
Gensure completed manual cleaning and steam sterilization validation
testing per the following guidance and standard document:
FDA guidance document, Reprocessing Medical Devices in Health
Care Settings: Validation Methods and Labeling, issued March 17,
2015.
AAMI TIR12: 2010 Designing, testing, and labeling reusable medical
devices for reprocessing in health care facilities: A guide for medical
device manufacturers.
AAMI TIR30: 2011/(R)2016 A compendium of processes, materials,
test methods, and acceptance criteria for cleaning reusable medical
devices.
ISO 17665- 1:2006 Sterilization of health care products - Moist heat -
Requirements for the development, validation, and routine control of
sterilization process for medical devices.
ISO 17665-2:2009 Sterilization of health care products - Moist heat -
Part 2: Guidance of the application of ISO 17665-1.
ISO 19227:2018 Implants for surgery - Cleanliness of orthopedic
implants - General requirements. | |
| Non-clinical test | | |
| Performance -
Animal | No animal study data is submitted in this 510(k). | |
| Performance -
Clinical | No clinical study data is submitted in this 510(k). | |
| Substantial
Equivalence | The Internal Locking Plate and Screw Fixation System is substantially
equivalent to the predicate device when evaluating intended use and
technological characteristics.
The subject device has the identical intended use as the predicate
device. The subject device and predicate devices are substantially | |
| | equivalent with only minor differences. These differences do not raise
new questions of safety and effectiveness. | |
| | The non-clinical data demonstrates the Internal Locking Plate and | |
| Conclusion | Screw Fixation System is substantially equivalent to the predicate | |
| | device. | |
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dislocations, osteotomies, and non-unions of the proximal humerus,
particularly in osteopenic bone.
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