(25 days)
N/A
No
The device description and performance studies focus on the mechanical properties and biological compatibility of a bone anchor, with no mention of AI or ML.
Yes
The Fix2Lock is intended for fixation of soft tissue to bone using suture in various orthopedic procedures, which directly addresses a medical condition or aims to alter the structure or function of the body for therapeutic purposes.
No
Explanation: The Fix2Lock is described as an absorbable bone fixation screw used in orthopedic surgery to fix soft tissues to bone. Its intended use is for various repair and reconstruction procedures in the shoulder, foot/ankle, knee, hand/wrist, and elbow. This is a therapeutic/fixation device, not a diagnostic one.
No
The device description explicitly states it is a "Bioabsorbable bone anchor" and consists of physical components like a "bone fixation screw," "suture," "driver shaft," and "handle." This indicates it is a physical medical device, not software-only.
Based on the provided information, the Fix2Lock device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fixation of soft tissue to bone, using suture, in the following procedure: shoulder, foot/ankle, knee, hand/wrist and elbow." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery." This is a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are used to perform tests on samples taken from the human body to provide diagnostic information. The Fix2Lock is a surgical device used for mechanical fixation within the body during a procedure.
N/A
Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
Input Imaging Modality
Not Found
Mentions AI, DNN, or ML
Not Found
Mentions image processing
Not Found
Product codes
MAI, MBI
Intended Use / Indications for Use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist and elbow.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 surgications
- ASTM F2848: 2021 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
- ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
▪ Mechanical performance
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
- ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
▪ 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 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2017, 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 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
- ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2019 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:2021 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
- ISO 11737-3:2023, Sterilization of health care products Microbiological methods Part 3: Bacterial endotoxin testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
N/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
December 3, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
OSTEONIC Co., Ltd. % Lee Sanglok Manager WISE COMPANY Inc. #1107, #1108, 204 Gasandigital 1-ro, Geumcheon-gu Seoul. 08502 Korea, South
Re: K243467
Trade/Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 8, 2024 Received: November 8, 2024
Dear Lee Sanglok:
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.
1
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" (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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS 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
3
Indications for Use
Submission Number (if known)
Device Name
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Indications for Use (Describe)
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ne-Counter Use (21 CFR 801 Subpart C)
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4
Date of Submission: 2024.11.08
01. Applicant
OSTEONIC Co., Ltd.
405Ho, 505-2Ho, 505-3Ho, 508Ho, 603Ho, 902Ho, 1004Ho, 1005Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24 Digital-ro 27-gil, Guro-gu, Seoul, Korea, 1012Ho, 1013Ho, 272, Digital-Ro, Guro-gu, Seoul, Korea TEL: +82-2-6902-8400 FAX: +82-2-6902-8401 Email: dakham@osteonic.com
02. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. 1107Ho, 1108Ho, 204 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
03. Subject Device Identification
Trade Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Common Name: Bioabsorbable bone anchor Classification Name: fastener, fixation, biodegradable, soft tissue Classification Product Code: MAI Subsequent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II
04. Predicate device
510(k) Number: K202806, K231326 Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic Co., Ltd.
05. Reference device
N/A
06. Device Description
The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.
07. Indication for use
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
5
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral
ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
6
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 surgications - ASTM F2848: 2021 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
-
ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
▪ Mechanical performance
-
ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
-
ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
▪ 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 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2017, 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 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
- ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2019 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:2021 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
- ISO 11737-3:2023, Sterilization of health care products Microbiological methods Part 3: Bacterial endotoxin testing
09. Comparison of Technological Similarities and Differences
Table 1: Substantial Equivalence Comparison
| Product Name | SUBJECT Device | Predicate Device
Fix2Lock(Biocomposite medial, lateral,
Biocombi Self Punching)(K231326,
K202806) | Equivalence
Discussion |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product code | MAI | MAI | Same |
| Regulatory class | Class II | Class II | Same |
| Regulation Number | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended use | The Fix2Lock is intended use for fixation
of soft tissue to bone, using suture, in the
following procedure;
shoulder, foot/ankle, knee, hand/wrist and
elbow.
Shoulder: Rotator Cuff Repair, Bankart
Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation. | The Fix2Lock is intended use for fixation
of soft tissue to bone, using suture, in the
following procedure;
shoulder, foot/ankle, knee, hand/wrist and
elbow.
Shoulder: Rotator Cuff Repair, Bankart
Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation. | Same |
7
| | Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial
Stabilization, Achilles Tendon Repair,
Metatarsal Ligament Repair, Hallux
Valgus reconstruction, digital tendon
transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair, Patellar
Tendon Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament
Reconstruction, Carpal Ligament
Reconstruction, Repair/Reconstruction of
collateral
ligaments, Repair of Flexor and Extensor
Tendons at the PIP, DIP, and MCP joints
for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment,
Ulnar or Radial Collateral Ligament
Reconstruction | Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial
Stabilization, Achilles Tendon Repair,
Metatarsal Ligament Repair, Hallux
Valgus reconstruction, digital tendon
transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair, Patellar
Tendon Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament
Reconstruction, Carpal Ligament
Reconstruction, Repair/Reconstruction of
collateral
ligaments, Repair of Flexor and Extensor
Tendons at the PIP, DIP, and MCP joints
for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar
or Radial Collateral Ligament
Reconstruction | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Operating
Principles | Bone fixation screw that ties soft tissues
such as ligament, tendon, and the articular
capsules to bone. | Bone fixation screw that ties soft tissues
such as ligament, tendon, and the articular
capsules to bone. | Same |
| | | | |
| Material | Anchor:
-Biocomposite medial, lateral: PLGA+β-
TCP
-Biocombi self punching: PLGA+β-TCP,
PEEK
Suture: UHMWPE | Anchor:
-Biocomposite medial, lateral: PLGA+β-
TCP
-Biocombi self punching: PLGA+β-TCP,
PEEK
Suture: UHMWPE | Same |
| Structure | This product consists of an absorbable
and/or non-absorbable anchor, a non-absorbable suture, needle and driver shaft
and handle. | This product consists of an absorbable
and/or non-absorbable anchor, a non-absorbable suture and driver shaft and
handle. | Same |
| Product
Size | Anchor diameter: Ø 3.75 to 6.5 mm
Anchor length: 12.0 to 14.0mm | Anchor diameter: Ø 2.6 to 6.5 mm
Anchor length: 10.0 to 20.8mm | 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 | 3Years | 3Years | Same |
The Product Size of subject device is similar with the predicate device. It is not exactly same but the is within the range of unmodified device and the safety was evaluated as the performance bench test.
10. Substantially Equivalent Conclusion
Based on above, the subject device, Fix2Lock (Biocomposite medial, lateral, Biocombi Self punching), is determined to be Substantially Equivalent (SE) to the predicate device(Unmodified device), Fix2Lock(Biocomposite medial, lateral, Biocombi Sef pundhing), (K202806, K231326) in respect of safety and effectiveness.