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스카이브, 한국인 맞춤 'PNK 인공관절' 개발

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작성일 23-08-30 13:32 조회 502

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식약처 허가 획득···1월부터 임상 활용

한국인 1만 2305명의 데이터를 기반으로 개발된 PNK 인공관절 (사진=연세사랑병원)
한국인 1만 2305명의 데이터를 기반으로 개발된 PNK 인공관절 
 

[증권경제신문=주길태 기자] 연세사랑병원이 한국인의 데이터를 기반으로 인공관절을 개발해 주목받고 있다.

3일 연세사랑병원 의료진과 정형외과 의료기기 회사 스카이브는 7년 간의 공동연구 끝에 개발한 ‘PNK 인공관절’은 지난해 봄 식약처 허가를 받은 데 이어 가을에 건강보험심사평가원에서 보험 수가를 적용 받았다. 올해 1월부터 임상에서 활용하고 있다.

PNK는 ‘Preservation of Normal knee Kinematics’의 약자로 ‘정상 무릎 운동학의 유지’라는 철학을 담고 있다. 즉, 인공관절 수술 후 무릎의 운동학을 정상 무릎에 가깝게 복원하겠다는 의지다. 눈 여겨 볼만한 특징은 인공관절이 150도 고굴곡이 가능하다는 점이다. 

실제로 PNK는 국내 환자의 데이터를 기반으로 개발됐다. PNK는 연세사랑병원에서 치료받은 환자 1만 2305명의 데이터를 기반으로 연구됐다.

연세사랑병원은 지난 7년간 대퇴골 관상면 곡률, 대퇴골 회전축, 경골의 사상면 곡률 등 다양한 연구를 진행해왔으며 이를 통해 측정한 해부학적 데이터는 PNK 인공관절 설계에 고스란히 반영됐다.

PNK의 특징 중 하나는 인공관절의 긴 수명을 위해 마모율에도 집중했다. 성능시험 결과에 따르면 PNK 인공관절의 마모율은 1, 2세대 인공관절 대비 낮은 결과를 보였고 3세대 인공관절인 어튠과 동등한 수준을 나타냈다. 또 전방 캠구조, 깊은 트로클리어 그루브, 후크 월 체결부 등 기술을 포함하고 있다.

연세사랑병원 의료진은 “한국인의 데이터를 기반으로 만들어진 새로운 인공관절을 병원에서 자체 개발한 맞춤형 수술도구와 함께 이용하면 수술 시간 단축 및 회복 기간 단축 등 수술 후 만족도에 좋은 영향을 줄 것”이라고 전했다.

스카이브 관계자는 “해외 제품 점유율이 높은 국내 무릎 임플란트 시장에서 경쟁력 있는 국내 제품이 출시된 것이다. 현재 한국뿐만 아니라 미국 식품의약국(FDA) 인증을 준비 중에 있다”고 말했다.

출처 : 증권경제신문

첨부파일

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Privacy Policy

In accordance with the Personal Information Protection Act, “SKYVE CO.,LTD.” Corporation (hereinafter “Company”) has the following processing policies to protect users' personal information and rights and interests, and to smoothly handle user complaints related to personal information. The customer's information is both an individual's valuable asset and an important data for company operation. Therefore, the company promises to do its best to protect your personal information in all operational processes. The company will notify you through the website when revising the privacy policy.

Chapter 1. Personal Information Collection Consent Procedure The

Company has prepared a procedure for you to click the (I agree) button or the (I do not agree) button for the contents of the personal information protection policy or terms of use of the website and press the (Agree) button. By clicking, you agree to the collection of personal information.

Chapter 2. Purpose of collection and use of personal information The company uses personal information for the following purposes.

The processed personal information will not be used for purposes other than the following purposes, and prior consent will be sought when the purpose of use is changed.

A. Name, ID, and password: Confirmation of the member's subscription, prevention of use of the service, frequency of access, identity identification procedures according to the use of membership services the correct delivery address for the delivery of prizes and goods

B. E-mail address, phone number (receipt or not): To secure a smooth communication path such as delivering notices, confirming personal intentions, handling complaints, etc., providing event and advertising information and providing opportunities to participate, identifying access frequency or using members About statistics

C. Address and phone number: Securing the correct delivery address for the delivery of prizes and goods

Chapter 3. Transmission of advertising information

A. The company does not send commercial information for commercial purposes against your explicit intention to opt out.

B. The Company will notify you of changes to the terms and conditions, changes to the use of other services, information on new services/new products or events, and other product information by e-mail, mobile phone text transmission, and other omniscient transmission media. In this case, we comply with the provisions and methods specified in relevant laws.

C. When the Company sends advertising information by e-mail, etc. for online marketing, such as product information guidance Make it easy for you to find out in the subject and body areas of your email.

Chapter 4. Scope of collection of personal information The

company can freely access most of the contents without a separate membership registration process. If you want to use the membership service, you must enter the following information.

A. Items of personal information collection: name, email, date of birth, ID, password, gender, address, mobile phone number (telephone), e-mail reception Sms reception, service use record, access message, incoming customer information (name, phone number, address, e-mail)

B. Personal information collection method: Membership registration and bulletin board on the website

Chapter 5. Retention and use period

of personal information After the purpose of collecting and using personal information is achieved, the company destroys the information without delay.
However, the following information is retained for the specified period for the following reasons.

  • Retention items: name, login ID, password, e-mail, date of birth
  • Basis for retention: Prevention of recurrence of illegal use by bad members
  • Retention period: 1 month

And, if it is necessary to preserve it in accordance with the provisions of the relevant laws and regulations, the company keeps the member information for a certain period specified in the relevant laws and regulations as follows. Records on consumer complaints or dispute handling: 3 years (Act on Consumer Protection in Electronic Commerce, etc.)

Chapter 6. Destruction procedure and method

of personal information In principle, the company destroys the personal information without delay when the purpose of processing personal information is achieved. The procedure, deadline, and method of destruction are as follows.

  • Destruction Procedure

    The information entered by the member for membership registration, etc., is transferred to a separate DB (separate filing cabinet in the case of paper) after the purpose is achieved and according to the reasons for information protection according to internal policies and other relevant laws (refer to retention and use period) It is destroyed after being stored for a certain period. Personal information transferred to a separate DB is not used for purposes other than retention unless required by law.

  • Abandonment period

    If the personal information of the user who has been destroyed has elapsed, within 5 days from the end of the retention period, the personal information has become unnecessary, such as achieving the purpose of processing personal information, abolishing the service, and ending the business. When it is deemed unnecessary to process personal information, the personal information will be destroyed within 5 days.

  • Destruction method

    Information in the form of electronic files uses a technical method that cannot reproduce the record

Chapter 7. Measures to ensure the safety

of personal information The company takes necessary measures to ensure safety as follows in accordance with Article 29 of the Personal Information Protection Act. of Employees Handling Personal Information We are implementing measures to manage personal information by designating and minimizing employees who handle personal information.

A. Minimization and training of personnel handling personal information We are implementing measures
to manage personal information by designating and minimizing personal information handling staff .

B. Encrypt personal information
The user's personal information is to encrypt, save and manage the password, only I can know, the important data is to encrypt files and transfer data, or use the file locking function and other security functions.

Chapter 8. Create a privacy officer

The Company is committed to making your information safe. The person responsible for handling your personal information is as follows and responds promptly and faithfully to any questions related to personal informatio

▶ Personal Information Protection Personnel

Name : 박누리

Affiliation/Title : 과장

e-mail : master@skyve.co.kr

TEL : 02-6952-8942

information subject handles all personal information protection related inquiries and complaints while using the company service , You can contact the person in charge of personal information protection and the person in charge for matters related to damage relief, etc.

Chapter 9. Collecting Opinions and Handling Complaints The

company values ​​your opinions, and you have the right to always receive sincere answers from questions. The company operates a customer center for smooth communication with members.


Real-time consultation and telephone consultation are available only during business hours. We will sincerely respond to consultations by email or mail within 24 hours after receipt. However, after working hours or on weekends and holidays, it is in principle to process the next business day.
The company's actions on the stolen personal information are as follows.

1. When a user becomes aware that he or she has signed up for membership by stealing other people's personal information, we will take necessary measures, such as suspension of service use or withdrawal of membership, without delay.

2. If a user who is aware of the theft of his or her personal information requests the suspension of service use or withdrawal from the member, take immediate action. If you need to consult with other personal information, you can contact the Personal Information Infringement Report Center, Supreme Prosecutors' Office Internet Crime Investigation Center, and the National Police Agency Cyber ​​Terror Response Center.

Personal Information Infringement Center (http://www.118.or.kr)

Supreme Prosecutors' Office Internet Crime Investigation Center (http://icic.sppo.go.kr)

National Police Agency Cyber ​​Terror Response Center (http://www.police.go .kr/ctrc/ctrc_main.htm)

Chapter 10. Obligations

of notification This personal information processing policy is applied from the effective date, and if there are any additions, deletions or corrections of changes in accordance with laws and policies, we will notify you through the notice from 7 days before the enforcement of the changes.

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Refusing to collect email addresses unauthorizedly

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