Park's Pectus System

K191057 · Tdm Co., Ltd. · HRS · Mar 19, 2020 · Orthopedic

Device Facts

• Record ID: K191057
• Device Name: Park's Pectus System
• Applicant: Tdm Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities

Device Story

Park's Pectus System is a surgical implant system used in the Minimally Invasive Repair of Pectus Excavatum (MIRPE). The system consists of metallic pectus bars and stabilizers designed to lift the sternum and correct concave chest wall deformities. The device is used by professional orthopedists in a surgical setting. The surgeon inserts the fixation bar into the thoracic cavity and secures it to the costal ribs. The bars are available in various lengths (6 to 17 inches) and can be pre-bent based on patient CT scans to match individual anatomy. The rounded, blunt edges of the bars are designed to minimize tissue destruction during insertion. By mechanically supporting the sternum in an elevated position, the device facilitates the remodeling of the chest wall, potentially improving respiratory and cardiac function in patients with severe deformities.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical bench testing, including 4-point bending tests, 4-point bending fatigue tests, and vertical tensile tests comparing the subject device to the predicate.

Technological Characteristics

Materials: Titanium Alloy (ASTM F136), Stainless Steel (ASTM F138, ASTM F139). Components: Pectus bars (6-17 inches), stabilizers, and surgical instruments. Design features: Rounded/blunt edges, pre-bent options based on CT scans. Biocompatibility: Compliant with ISO 10993. Sterilization: Not specified (non-sterile packaging).

Indications for Use

Indicated for patients with congenital deformity of the sternum and anterior chest wall. Contraindicated in patients with mental/neurological conditions unwilling or incapable of following instructions, patients with metal sensitivity, patients with insufficient bone/fibrous tissue quality or quantity, and patients with infection.

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

• Lorenz Pectus Support Bar System (K061384)

Reference Devices

• TDM Plate and Screw System (K171808)
• TDM Plate and Screw System (K190391)

Submission Summary (Full Text)

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March 19, 2020

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 and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

TDM Co. Ltd. % Dave Kim Medical Device Regulatory Affairs Dave Kim 1830 Buffalo Speedway Houston, Texas 77025

Re: K191057

Trade/Device Name: Park's Pectus 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 Dated: April 10, 2019 Received: April 22, 2019

Dear Dave Kim:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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, MPH 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

Enclosure

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# Indications for Use

510(k) Number (if known) K191057

Device Name Park's Pectus System

#### Indications for Use (Describe)

Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary K191057

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92

Date: 2/17/2020

## 1. 510K Applicant / Submitter:

TDM CO., LTD. 69, Cheomdan venture so-ro 37beon-gil, Buk-gu, Gwangju, 61003, REPUBLIC OF KOREA Tel: [phone] Fax: [phone] Establishment registration number: 3014257776

## 2. Submission Contact Person

Dave Kim, MBA Mtech Group 7707 Fannin St. Ste 200. V111 Houston, TX 77054 Phone: [phone] Email: [e-mail]

## 3. Device

| - Trade / Device Name : | Park's Pectus System |
|-------------------------|----------------------|
|-------------------------|----------------------|

- -. Common Name : Pectus Excavatum System
- -. Classification Name : Plate, Fixation, Bone
- -. Regulation Number : 21 CFR 888.3030
- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class : II
- -. Product Code : HRS

## 4. Primary predicate Device

- -. Trade / Device Name : Lorenz Pectus Support Bar System
II

- -. 510(k) Number : K061384
- -. Regulation Number : 21 CFR 888.3030
- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class :
- -. Product Code : HRS

## 5. Reference Device

#### 5.1 Reference Device #01

| -. Trade / Device Name : | TDM Plate and Screw System |
|--------------------------|----------------------------|
| -. 510(k) Number : | K171808 |
| -. Regulation Number : | 21 CFR 888.3030 |

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- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class :
- -. Product Code : HRS. HWC

## 5.2 Reference Device #02

- -. Trade / Device Name : TDM Plate and Screw System
II

- -. 510(k) Number : K190391
- -. Regulation Number : 21 CFR 888.3030
- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class : II
- -. Product Code : HRS. HWC

## 6. Description:

Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

## 7. Indications for Use

Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.

## 8. Substantial Equivalence Discussion:

The Park's Pectus System is substantially equivalent to Lorenz Pectus Support Bar System (K061384). The following comparison table is presented to demonstrate substantial equivalence.

| | Candidate Device | Primary predicate | Substantial<br>Equivalence<br>Analysis |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | K191057 | K061384 | - |
| Device Name | Park's Pectus System | Lorenz Pectus Support Bar System | - |
| Common Name | Single/multiple component<br>metallic bone fixation appliances<br>and accessories | Single/multiple component<br>metallic bone fixation appliances<br>and accessories | - |
| Manufacturer | TDM CO., LTD. (Korea) | Biomet Microfixation Inc. (USA) | - |
| Indication for<br>Use | Park's Pectus System is intended<br>for use in surgical procedures to<br>repair Pectus Excavatum and other<br>anterior chest wall deformities. | This device is intended for use in<br>surgical procedures to repair<br>Pectus Excavatum and other chest<br>wall deformities. | Substantial<br>Equivalence |
| Indication | Congenital deformity of the<br>sternum and anterior chest wall | Congenital deformity of the<br>sternum and anterior chest wall | Substantial<br>Equivalence |
| Contraindicatio<br>n | - Patients with mental or<br>neurological conditions who are<br>unwilling or incapable of following<br>instructions.<br>- Patients presenting metal<br>sensitivity reactions. | - Patients with mental or<br>neurological conditions who are<br>unwilling or incapable of following<br>instructions.<br>- Patients presenting metal<br>sensitivity reactions. | Substantial<br>Equivalence |
| | | | |
| | - Patients with insufficient quantity<br>or quality of bone or fibrous tissue<br>to allow remodeling.<br>- Infection | - Patients with insufficient quantity<br>or quality of bone or fibrous tissue<br>to allow remodeling.<br>- Infection | |
| Raw Material | Titanium Alloy (ASTM F136)<br>Stainless Steel (ASTM F138 &<br>ASTM F139) | Titanium Alloy (ASTM F136)<br>Stainless Steel (ASTM F138) | Substantial<br>Equivalence |
| Feature | - The Pectus Bar's rounded ends<br>and blunt edges help minimize<br>tissue destruction during implant<br>insertion.<br>- The Pectus Bar comes in a variety<br>of lengths ranging from 6 inches to<br>17 inches to accommodate most<br>Pectus Excavatum correction<br>procedures<br>- All instruments in the Pectus<br>System are designed to increase<br>simplicity during the Nuss<br>Procedure.<br>- The Pectus System Container<br>comes in two sizes and<br>conveniently houses the entire<br>range of Pectus implants and<br>instruments<br>- Specialized titanium bars and<br>stabilizers available for patients<br>with nickel allergies<br>- Pectus-size bars available for the<br>following:<br>① Special sized bars<br>② Pre-bent bars developed in<br>accordance with patients' CT scans | - The Pectus Bar's rounded ends<br>and blunt edges help minimize<br>tissue destruction during implant<br>insertion.<br>- The Pectus Bar comes in a variety<br>of lengths ranging from 7 inches to<br>17 inches to accommodate most<br>Pectus Excavatum correction<br>procedures.<br>- All instruments in the Pectus<br>System are designed to increase<br>simplicity during the Nuss<br>Procedure.<br>- The Pectus System Container<br>comes in two sizes and<br>conveniently houses the entire<br>range of Pectus implants and<br>instruments<br>- Specialized titanium bars and<br>stabilizers available for patients<br>with nickel allergies<br>- Pectus-size bars available for the<br>following:<br>① Special sized bars<br>② Pre-bent bars developed in<br>accordance with patients' CT scans | Substantial<br>Equivalence |
| Surgical<br>Procedure | MIRPE<br>(Minimally Invasive Repair of<br>Pectus Excavatum) | MIRPE<br>(Minimally Invasive Repair of<br>Pectus Excavatum) | Substantial<br>Equivalence |
| Pectus Bar<br>Length | 6 inch ~ 17 inch | 7 inch ~ 17 inch | Substantial<br>Equivalence |
| Single use | Yes | Yes | Substantial<br>Equivalence |
| Non-Sterile<br>Packaging | Yes | Yes | Substantial<br>Equivalence |
| Target<br>Population | Patients with congenital deformity<br>of the sternum and anterior chest<br>wall | Patients with congenital deformity<br>of the sternum and anterior chest<br>wall | Substantial<br>Equivalence |
| Anatomical Site | Sternum and anterior chest wall | Sternum and anterior chest wall | Substantial<br>Equivalence |
| Location of Use | Use only by professional<br>orthopedists | Use only by professional<br>orthopedists | Substantial<br>Equivalence |
| Bio-<br>compatibility | All user directly contacting<br>materials are compliance with<br>ISO10993 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993 requirements. | Substantial<br>Equivalence |

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Park's Pectus System and the primary predicate device[Lorenz Pectus Support Bar System (K061384)] have identical indication for use statements and the same intended use.

The device specifications and materials are equal to the primary predicate device/Lorenz Pectus Support Bar System (K061384)] in all parameters.

The materials and sterilization method for Parks Pectus System including class I and class II accessories are identical to TDM plate and screw systems cleared by FDA (K190391)

Therefore, the Park's Pectus System is substantially equivalent to the primary predicate device[Lorenz Pectus Support Bar System (K061384)].

## 9. Performance Tests (Non-clinical)

Non-clinical performance tests, including 4-point bending test, 4-point bending fatigue test, vertical tensile test, were performed by comparing Park's pectus system with Lorenz pectus support bar system (K061384). The selection rationale of the test sample was based on the worst case scenario, a pectus bar with the longest and thinnest in size. All Park's pectus bar has the same width. The size of Park's pectus bars tested are 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. For material, both stainless and titanium pectus bars were tested. Pectus bars with both rounded end and serrated end were also tested. Other accessories (fixator driver, applier, bar removal bender, clamp, flipper, table top bender, easy crane system, flare compressor, and fixator container) were not considered in this test since there have been well established safety and effectiveness history for class I stainless and titanium surgical instruments.

-. ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates

## 10. Biocompatibility Tests

The materials for Parks Pectus System including class I accessories are identical to TDM plate and screw systems (K171808/K190391) cleared by FDA.

ASTM F138 & ASTM F139 stainless steel, the same materials used for Park's Pectus Bar System. have been raised in literature; no studies have conclusive evidence that metal wear debris or metal ions are carcinogenic.

"The [Titanium Alloy(ASTM F136)] of Park's Pectus Bar in its final finished form is identical to the [Titanium Alloy(ASTM F136)] of the [TDM Plate And Screw System (K171808/ K190391) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."

" Park's Pectus Bar in its final finished form is identical to [TDM Plate And Screw System (K171808/K190391) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents)."

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# 11. Summary of Clinical Tests

Clinical testing was not required to demonstrate the substantial equivalence of the Park's Pectus System to its primary predicate device.

## 12. Conclusions:

Based on the information provided in this premarket notification, TDM CO., LTD. concludes that the Park's Pectus System is substantially equivalent to the primary predicate as described herein.