Internal Locking Plate and Screw Fixation System

K232394 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · HRS · Dec 15, 2023 · Orthopedic

Device Facts

• Record ID: K232394
• Device Name: Internal Locking Plate and Screw Fixation System
• Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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. 3.5mm 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.

Device Story

Internal Locking Plate and Screw Fixation System; metallic bone fixation plates and screws for traumatic and reconstructive surgery. Plates feature locking and non-locking screw holes to facilitate dynamic compression; screws lock into plates via threaded heads. Used in hospital settings by surgeons for temporary bone stabilization. System preserves cortical bone perfusion compared to conventional compression plates. Device provides mechanical support to bone fragments during healing; benefits include stable fixation in various anatomical sites, including osteopenic bone.

Clinical Evidence

No clinical data submitted. Bench testing only: Single Cycle Bend and Fatigue Property testing (ASTM F382-17); Torsional, Driving Torque, Axial Pullout, and Self-Tapping performance testing (ASTM F543-17).

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) ELI. Construct: Locking plate and screw system. Plate lengths 45-316mm; 3-22 holes. Screw diameters 2.0-6.5mm. Sterilization: Non-sterile, validated for manual cleaning and steam sterilization. Standards: ASTM F382-17 (plates), ASTM F543-17 (screws).

Indications for Use

Indicated for temporary fixation, correction, or stabilization of fractures, malunions, non-unions, osteotomies, and fracture dislocations in various anatomical regions (clavicle, humerus, radius, femur, tibia, fibula, pelvis, and small bones of hand/wrist/foot/ankle). Suitable for use in normal or osteopenic bone.

Regulatory Classification

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.

Predicate Devices

• Synthes (USA) Modular Mini Fragment LCP System (K063049)
• Synthes 3.5mm LCP Clavicle Plate System (K073186)
• Synthes LCP Proximal Humerus Plate (K011815)
• 3.5mm LCP Distal Humerus System (K033995)
• Synthes 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K083694)
• Synthes LCP Distal Femur Plate (K062564)
• Synthes (USA) 3.5/4.5mm LCP Medial Proximal Tibia Plates (K032269)
• Synthes (USA) 2.7mm /3.5mm LCP Anterolateral Distal Tibia Plates (K092812)
• Synthes 2.7mm/3.5mm LCP Distal Fibula Plates-Modification (K083213)
• Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807)

Reference Devices

• Spinal Inner Fixation System (K222031)

Submission Summary (Full Text)

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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"

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### 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 ([e-mail]) or phone [phone] 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

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## 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.

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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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# 510(K) Summary

## K232394

| Preparation Date: | Dec. 09, 2023 | |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd<br>No. 12, Jinfeng Road, West Taihu Science and Technology Industrial<br>Park, Changzhou, Jiangsu, P.R. China | |
| Contact | Jing Huang, Management Representative<br>Changzhou Geasure Medical Apparatus and Instruments Co., Ltd<br>No. 12, Jinfeng Road, West Taihu Science and Technology Industrial<br>Park, Changzhou, Jiangsu, P.R. China<br>Postcode: 213149<br>Email: [e-mail]<br>Phone:[phone] | |
| Designated<br>Submission<br>Correspondent | Company: Sinow Medical AS<br>Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway<br>Contact Person: Xiaoqing Xue<br>Telephone: [phone]<br>Email: [e-mail] | |
| 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;<br>Smooth or threaded metallic bone fixation fastener; |
| | Product Codes | HRS, HWC |
| | Common name for<br>product codes | HRS:Plate Fixation, Bone<br>HWC: Screw, Fixation, Bone |
| | Manufacturer | DePuy Synthes |
| | | |
| Primary Predicate<br>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;<br>Smooth or threaded metallic bone fixation fastener; |
| | Product Codes | HRS, HWC |
| | Common name for | HRS:Plate Fixation, Bone |
| Additional Predicate<br>Devices | product codes | HWC: Screw, Fixation, Bone |
| | Manufacturer | DePuy Synthes |
| | | K073186, Synthes 3.5mm LCP Clavicle Plate<br>System; |
| | | K011815, Synthes LCP Proximal Humerus Plate; |
| | | K033995, 3.5mm LCP Distal Humerus System; |
| | | K083694, Synthes 2.4mm VA-LCP<br>Two-Column Volar Distal Radius Plate; |
| | Trade name /510(K)<br>number | K062564, Synthes LCP Distal Femur Plate; |
| | | K032269, Synthes (USA) 3.5/4.5mm LCP<br>Medial Proximal Tibia Plates; |
| |…