(266 days)
Not Found
No
The summary describes a mechanical bone anchor and suture system with no mention of AI or ML capabilities.
Yes
The device is intended for fixation of soft tissue to bone in orthopedic surgery, which is a therapeutic purpose.
No
The device description clearly states it is for "fixation of soft tissue to bone, using suture, in orthopedic surgery." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is a physical product consisting of an anchor, sutures, and a driver shaft made of Nitinol, intended for surgical implantation. It is a sterile, single-use hardware device.
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 orthopedic surgery." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone anchor-all suture" used for "soft tissue fix such as ligaments, tendons, and capsules to bone." This describes a physical implant used during surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant used for mechanical fixation within the body, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
Product codes
MBI
Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft(Nitinol) for anchor insertion. This product is sterilized product and single use only.
Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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
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 F2848, ASTM F2063)
- Mechanical performance (ASTM F543, ASTM F1839)
- Sterilization, shelf-life and packaging for sterile product (ISO 11135, ISO 11138-1, ISO 11138-2, ISO 11140-1, ISO 11737-1, ISO 11737-2, ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM F88/F88M, ASTM F1929)
- Bacterial Endotoxin (USP , USP )
- Material mediated pyrogenicity (USP , ISO 10993-11)
- Insertion test (FDA guidance: Bone Anchors Premarket notification (510(K)) Submissions, ASTM F1839)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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June 7, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, Seoul 08507 Korea, Republic of
Re: K202663
Trade/Device Name: Suture Wing Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 4, 2021 Received: May 6, 2021
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 mav, 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
1
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 (OS) 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,
Pooja Panigrahi -S
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
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Indications for Use
510(k) Number (if known) K202663
Device Name Suture Wing
Indications for Use (Describe)
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 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, black letters on the right. Below the word "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter font.
The assigned 510(k) Number: K202663
01. Date of Submission: 2020.09.11
02. Applicant
Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho, 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: Suture Wing Common Name: Sterile bone anchor-all suture Classification Name: fastener, fixation, non-biodegradable, soft tissue Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Device Class: II
05. Indication for use
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
06. Predicate devices
Predicate device 510(k) Number: K133224 Device Name: Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures Manufacturer: ConMed Corporation
07. Device Description
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft(Nitinol) for anchor insertion. This product is sterilized product and single use only.
Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.
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:
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Image /page/4/Picture/1 description: The image contains a logo for Osteonic. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in bold, dark gray letters on the right. Below "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter gray font.
▪ Material
- ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns - ASTM F2063: 2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
▪ Mechanical performance
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
- ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polywethane foam for use as a standard material for testing orthopaedic devices and instruments
▪ 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
- Material mediated pyrogenicity
- USP Pyrogenicity Test
- ISO 10993-11: Tests for systemic toxicity
▪ Insertion test
- FDA guidance : Bone Anchors Premarket notification (510(K)) Submissions
- ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments
09. Substantially Equivalent Conclusion
Table 1: Substantial Equivalence Comparison
| Product
Name | SUBJECT Device | PREDICATE Device
Y-Knot RC All-suture anchor w/Two and
Three #2 Hi-Fi Sutures (K133224) | 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 |
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Image /page/5/Picture/1 description: The image contains a logo for a company called OSTEONIC. The logo consists of a blue geometric shape resembling a stylized diamond or cube, positioned to the left of the company name. Below the company name, there is a tagline that reads "The Medical Explorer" in a smaller font size.
| Intended use | Suture wing is intended for fixation of soft
tissue to bone, using suture, in orthopedic
surgery. | The non-absorbable suture anchors are
intended to reattach soft tissue to bone in
orthopedic surgical procedures. | Same |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------|
| Operating
Principles | Bone fixation anchor that ties soft tissues
such as ligament, tendon, and the articular
capsules to bone. | Bone fixation anchor that ties soft tissues
such as ligament, tendon, and the articular
capsules to bone. | Same |
| Material | Anchor and suture:
UHMWPE | Anchor and suture:
UHMWPE | Similar |
| Structure | This product consists of a non-absorbable all
suture and driver shaft and handle. | This product consists of a non-absorbable all
suture and driver shaft and handle. | Similar |
| Product
Size | 1.7mm/ 2.8mm | 1.8mm/ 2.8mm | 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 | 5 Years | 5 Years | Same |
Based on above, the subject device, Suture Wing, is Substantially Equivalent (SE) to the predicate devices, Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures (K133224) in respect of safety and effectiveness.