(256 days)
No
The device description and performance studies focus on the mechanical and material properties of a surgical implant and its insertion tools, with no mention of AI or ML.
No.
The device is used for fixation of soft tissue to bone during orthopedic surgery; it is not described as directly administering therapy or having a therapeutic effect.
No
Explanation: The device, Fix2Lock, is an implantable surgical device used for fixation of soft tissue to bone during orthopedic surgery. Its intended use is therapeutic (fixation), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states the product is an implant made of PEEK with non-absorbable suture and includes a Driver Handle and Driver Shaft for anchor insertion, indicating it is a physical 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 is for "fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is an "implant part is made of PEEK... with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion." This is a physical implant and associated tools used during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The Fix2Lock device is a surgical implant and instrument used in vivo (within the living body) during orthopedic surgery, not for testing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulders and knees
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgery
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)
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
▪ Material
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications
- ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
▪ Mechanical performance - ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
= Sterilization, shelf-life and packaging for sterile product - ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2009, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014. Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
June 4, 2021
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Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, Seoul 08507 Korea, Republic Of
Re: K202763
Trade/Device Name: Fix2Lock (PEEK Self Punching) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 17, 2020 Received: September 21, 2020
Dear Sanglok Lee:
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 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
1
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 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,
for
Laura C. Rose, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K202763
Device Name Fix2Lock (PEEK Self Punching)
Indications for Use (Describe)
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees.
| 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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3
Image /page/3/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a blue, three-dimensional structure composed of interconnected lines, resembling a stylized cube or diamond. To the right of the shape, the word "OSTEONIC" is written in bold, dark blue letters. Below "OSTEONIC", there is a smaller line of text that reads "The Medical Explorer".
510(k) Summary
4
Image /page/4/Picture/1 description: The image shows the logo for Osteonic. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in bold, dark blue letters on the right. Below the word "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter font.
The assigned 510(k) Number: K202763
01. Date of Submission: 2020.09.17
02. Applicant
Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8456 FAX: +82-2-6902-8401 Email: dakham@osteonic.com
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Subject Device Identification
Trade Name: Fix2Lock (PEEK Self Punching) Common Name: fastener, fixation, non-biodegradable, soft tissue Classification Name: Smooth or threaded metallic bone fixation fastner Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastner Device Class: II
05. Indication for use
Fix2Lock is intended use for fixation of soft tissue to bone, in the following procedure;Orthopedic surgery for shoulders and knees.
06. Predicate devices
Predicate device 510(k) Number: K143745 Device Name: Arthrex Corkscrew and SwiveLock Suture Anchors Manufacturer: Arthrex, Incorporated
Reference device 510(k)Number: K202883 Device Name: Sterile bone screw (PEEK ACL screw) Manufacturer: OSTEONIC Co., Ltd.
07. Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.
5
Image /page/5/Picture/1 description: The image contains the logo for Osteonic. The logo features a blue geometric shape resembling a stylized diamond or cube, with a smaller shape inside. To the right of the geometric shape, the word "OSTEONIC" is written in bold, dark gray letters. Below "OSTEONIC", the phrase "The Medical Explorer" is written in a smaller, lighter font.
08. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
▪ Material
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications - ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
· Mechanical performance
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
- = Sterilization, shelf-life and packaging for sterile product
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2009, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014. Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
09. Substantially Equivalent Conclusion
Table 1: Substantial Equivalence Comparison
| Product
Name | SUBJECT Device | PREDICATE Device
Arthrex Corkscrew and SwiveLock Suture
Anchors (K143745) | Equivalence
Discussion |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product
code | MBI | MBI | Same |
| Regulatory
class | Class II | Class II | Same |
| Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| Intended use | Fix2Lock is intended use for fixation of soft
tissue to bone, using suture, in the
following procedure; Orthopedic surgery for
shoulders and knees. | The Arthrex Corkscrew and SwiveLock
Suture Anchors are intended to be used for
fixation of suture(soft tissue) to bone in the
shoulder, foot/ankle, hip, knee, hand/wrist,
and elbow in the orthopedic surgical
procedures. | Same |
| Operating
Principles | This product is used for orthopedic surgery,
which soft tissue fix such as ligaments,
tendons, and capsules to bone | Bone fixation anchor that ties soft tissues
such as ligament, tendon, and the articular
capsules to bone. | Same |
6
Image /page/6/Picture/1 description: The image contains the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or cube structure. To the right of the shape, the word "OSTEONIC" is written in bold, dark lettering. Below "OSTEONIC", the tagline "The Medical Explorer" is written in a smaller, lighter font.
| Material | PEEK anchor and non-absorbable sutures | PEEK anchor and non-absorbable sutures | Similar |
|---|---|---|---|
| Structure | This product consists of an implanted | ||
| anchor, non-absorbable suture, driver shaft | |||
| and handle | This product consists of an implanted | ||
| anchor, non-absorbable suture, driver shaft | |||
| and handle | Similar | ||
| Product | |||
| Size | 4.5mm type / 5.5mm type | 4.75mm type / 5.5mm type | Similar |
| Sterilization | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Same |
| Single Use/ | |||
| Reuse | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | Same |
| Shelf -life | 5Years | 5 Years | Same |
Based on above, the subject device, Fix2Lock (PEEK Self Punching), is determined to be Substantially Equivalent (SE) to the predicate devices, Arthrex Corkscrew and SwiveLock Sutures (K143745) in respect of safety and effectiveness.