(23 days)
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, 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
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 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
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.
The provided text describes a 510(k) premarket notification for a medical device called Fix2Lock. It details the device's indications for use, comparison to predicate devices, and non-clinical test conclusions. However, it does not contain information about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types used in a study to prove acceptance criteria for a software device.
This document is for a physical medical device (bioabsorbable bone anchor) and the "studies" mentioned are bench tests verifying compliance with material, mechanical performance, sterilization, shelf-life, packaging, and bacterial endotoxin standards. These are typical engineering and safety tests for a physical implant, not studies involving AI or software performance against clinical ground truth.
Therefore, I cannot fulfill your request for information related to AI/software acceptance criteria and studies, as the provided document does not contain this type of information.
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May 31, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasandigital 2-ro, Geumcheon-gu Seoul. 08507 Korea, South
Re: K231326
Trade/Device Name: Fix2Lock(Biocomposite medial, 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: April 1, 2023 Received: May 8, 2023
Dear Mr. 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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sara S. Thompson -S
For
Yu-Chieh Chiu, Ph.D. Acting 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) K231326
Device Name
Fix2Lock (Biocomposite medial, 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, 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
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 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) |
|---|
| ------------------------------------------------- |
X 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/1 description: The image shows the logo for Osteonic, a medical company. The logo features a geometric design of nested squares in blue, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, sans-serif font, with the tagline "The Medical Explorer" appearing in a smaller font size beneath it.
The assigned 510(k) Number: K231326
Date of Submission: 2023.04.01
01. Applicant
OSTEONIC Co., Ltd. 405Ho, 505-2Ho, 505-3Ho, 508Ho, 902Ho, 1004Ho, 1005Ho, 1201Ho, 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
02. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. 08503, #507, #508, 166 Gasan digital 2-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, non-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 Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic Co., Ltd.
05. Reference device
510(k) Number: K192032 Device Name: Fixone Biocomposite Small Anchor Manufacturer: AJU Pharm Co., Ltd..
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.
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Image /page/4/Picture/1 description: The image shows the logo for Osteonic. The logo consists of a blue square with a white outline and a white line running through the middle. To the right of the square is the word "OSTEONIC" in bold, dark gray letters. Below the word "OSTEONIC" is the phrase "The Medical Explorer" in a smaller, lighter gray font.
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, SLAP Lesion 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
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
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Image /page/5/Picture/1 description: The image shows the logo for Osteonic. The logo consists of a blue square with a smaller square inside, and the word "OSTEONIC" in bold, black letters. Below the word "OSTEONIC" is the phrase "The Medical Explorer" 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 with the following standards:
▪ Material
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgications - 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 <85> Bacterial Endotoxin Test
- USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
09. Comparison of Technological Similarities and Differences
| ProductName | SUBJECT Device | Predicate Device | REFERENCE Device | EquivalenceDiscussion |
|---|---|---|---|---|
| Product code | MAI | MAI, | MAI | Same |
| Regulatoryclass | Class II | Class II | Class II | Same |
| RegulationNumber | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended use | The Fix2Lock is intended use forfixation of soft tissue to bone,using suture, in the followingprocedure;shoulder, foot/ankle, knee,hand/wrist and elbow.Shoulder: Rotator Cuff Repair, | Fix2Lock(Biocomposite medial,lateral, Biocombi SelfPunching)(K202806) | Fixone Biocomposite SmallAnchor (K192032) | Same |
| Bankart Repair, SLAP LesionRepair, Biceps Tenodesis,Acromio-Clavicular SeparationRepair, Deltoid Repair, CapsularShift or CapsulolabralReconstructionFoot/Ankle: Lateral Stabilization,Medial Stabilization, AchillesTendon Repair, MetatarsalLigament Repair, HalluxValgus reconstruction, digitaltendon transfers, Mid-footreconstructionKnee: Medial Collateral LigamentRepair, Lateral CollateralLigament Repair, Patellar TendonRepair, Posterior ObliqueLigament Repair, Iliotibial BandTenodesisHand/Wrist: ScapholunateLigament Reconstruction, CarpalLigament Reconstruction,Repair/Reconstruction ofcollateralligaments, Repair of Flexor andExtensor Tendons at the PIP, DIP,and MCP joints for all digits,digital tendon transfersElbow: Biceps TendonReattachment, Ulnar or RadialCollateral LigamentReconstruction | Shoulder: Rotator Cuff Repair,Bankart Repair, SLAP LesionRepair, Biceps Tenodesis,Acromio-Clavicular SeparationRepair, Deltoid Repair,Capsular Shift or CapsulolabralReconstructionFoot/Ankle: LateralStabilization, MedialStabilization, Achilles TendonRepair, Metatarsal LigamentRepair, HalluxValgus reconstruction, digitaltendon transfers, Mid-footreconstructionKnee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Patellar Tendon Repair,Posterior ObliqueLigament Repair, IliotibialBand TenodesisHand/Wrist: ScapholunateLigament Reconstruction,Carpal LigamentReconstruction,Repair/Reconstruction ofcollateralligaments, Repair of Flexor andExtensor Tendons at the PIP,DIP, and MCP joints for alldigits, digital tendon transfersElbow: Biceps TendonReattachment, Ulnar or RadialCollateral LigamentReconstruction | Shoulder: Rotator Cuff Repair,Bankart Repair, SLAP LesionRepair, Biceps Tenodesis,Acromio-Clabicular SeparationRepair, Deltoid Repair, CapsularShift or CapsulolabralReconstructionFoot/Ankle: LateralStabilization, MedialStabilization, Achilles TendonRepair, Metatarsal LigamentRepair, HalluxValgus reconstruction, digitaltendon transfers, Mid-footreconstructionKnee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Patellar Tendon Repair,PosteriorOblique Ligament Repair,Iliotibial Band TenodesisK192032006_510(k) SummaryPage 2 / 4Hand/Wrist: ScapholunateLigament Reconstruction,Carpal LigamentReconstruction,Repair/Reconstruction ofcollateral ligaments, Repair ofFlexor and Extensor Tendons atthe PIP, DIP, and MCP joints forall digits, digitaltendon transfersElbow: Biceps TendonReattachment, Ulnar or RadialCollateral LigamentReconstructionHip: Capsular repair, AcetabularLabral repair | ||
| Bone fixation screw that ties soft | Bone fixation screw that ties soft | The Fixone Biocomposite SmallAnchor is intended for reattachingsoft tissue to bone with sutures. | ||
| OperatingPrinciples | tissues such as ligament, tendon,and the articular capsules to bone. | tissues such as ligament, tendon,and the articular capsules tobone. | Same | |
| Material | Anchor:-Biocomposite medial, lateral:PLGA+ $\beta$ -TCP-Biocombi self punching:PLGA+ $\beta$ -TCP, PEEKSuture: UHMWPE | Anchor:-Biocomposite medial, lateral:PLGA+ $\beta$ -TCP-Biocombi self punching:PLGA+ $\beta$ -TCP, PEEKSuture: UHMWPE | PLGA+ $\beta$ -TCP | Same |
| Structure | This product consists of anabsorbable and/or non-absorbableanchor, a non-absorbable suture,needle and driver shaft and handle. | This product consists of anabsorbable and/or non-absorbable anchor, a non- | Driver, Anchor, Suture and needle | Same |
| absorbable suture and driver | ||||
| shaft and handle. | ||||
| Product Size | Anchor diameter: Ø 2.6 to 4.8 mmAnchor length: 10.0 to 16.0mm | Anchor diameter: Ø 2.6 to 6.5 mmAnchor length: 10.0 to 20.8mm | Anchor diameter : Ø 3.0mmLength : 11.9mm | Similar |
| Sterilization | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Same |
| Single Use/Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | - | Same |
| Shelf -life | 3Years | 5Years | - | Same |
Table 1: Substantial Equivalence Comparison
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Image /page/6/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 gray letters on the right. Below "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter gray font.
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Image /page/7/Picture/1 description: The image shows the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or square with internal lines, positioned to the left of the company name. The text "OSTEONIC" is written in bold, dark lettering, and below it, in smaller font, is the tagline "The Medical Explorer."
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 Self pundhing), (K202806) in respect of safety and effectiveness.
§ 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.