(25 days)
No
The summary describes a mechanical orthopedic fixation device and its materials and performance testing, with no mention of AI or ML.
Yes
The device is intended for the "fixation of soft tissue to bone, using suture, in orthopedic surgery," which directly addresses a medical condition or injury to restore function.
No
The device description clearly states its purpose is for "fixation of soft tissue to bone, using suture" in orthopedic surgery, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is an "implant part is made of PEEK" and includes a "Driver Handle and Driver Shaft for anchor insertion," indicating it is a physical medical device with hardware components, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Fix2Lock is for "fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery". This is a surgical procedure performed directly on a patient's body.
- Device Description: The device description details an implant made of PEEK with suture, a driver handle and shaft for insertion. This is a physical device 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.
This device is a surgical implant and associated tools, not a device used for testing biological samples outside of the 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, knees, foot/ankle, hand/wrist and elbow.
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 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, knees, foot/ankle, hand/wrist and elbow.
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:
- ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications
- ASTM F2848: 2021 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
- ASTM F543: 2017 Standard specification and test methods for metallic medical bone screws
- 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 Third edition 2017-03, 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 Third edition 2019-12, 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 Second edition 2019-02, Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2 Second edition 2019-02, 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-21 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
- 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
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
December 3, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Osteonic Co., Ltd. % Lee Sanglok Manager Wise Company Inc. #1107, #1108, 204 Gasandigital 1-ro, Geumcheon-gu Seoul. 08502 Korea, South
Re: K243470
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: 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 (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, knees, foot/ankle, hand/wrist and elbow.
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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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: +82-2-6902-8442 FAX: +82-2-6902-8401 Email: dhkim@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 (PEEK Self Punching) Common Name: fastener, fixation, non-biodegradable, soft tissue Classification Name: Smooth or threaded metallic bone fixation fastener Classification Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Device Class: II
04. Predicate Device
510(k) Number: K231322 Device Name: Fix2Lock (PEEK Self Punching) Manufacturer: Osteonic Co., Ltd.
05. Reference Device
510(k) Number: K233893 Device Name: AlphaVent Knotless SP PEEK Anchor Manufacturer: Stryker Endoscopy
06. 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.
07. Indication for use
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.
5
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: 2021 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
· Mechanical performance
- ASTM F543: 2017 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 Third edition 2017-03, 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 Third edition 2019-12, 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 Second edition 2019-02, Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2 Second edition 2019-02, 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-21 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
6
09. Comparison of Technological Similarities and Differences
Table 1: Substantial Equivalence Comparison
| Modified(Subject) Device | Unmodified(Predicate) Device | REFERENCE Device | ||
|---|---|---|---|---|
| Product | ||||
| Name | Fix2Lock (PEEK Self Punching), | Fix2Lock (PEEK Self Punching), | ||
| K231322 | AlphaVent Knotless SP PEEK | |||
| Anchor, K233893 | Equivalence | |||
| Discussion | ||||
| Product code | MBI | MBI | MBI | Same |
| Regulatory | ||||
| class | Class II | Class II | Class II | Same |
| Regulation | ||||
| Number | 21 CFR 888.3040 | 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, | ||||
| knees, foot/ankle, hand/wrist and | ||||
| elbow. | Fix2Lock is intended use for | |||
| fixation of soft tissue to bone, using | ||||
| suture, in the following procedure; | ||||
| Orthopedic surgery for shoulders, | ||||
| knees, foot/ankle, hand/wrist and | ||||
| elbow. | The AlphaVent Knotless SP PEEK | |||
| Anchor is intended to be used for | ||||
| soft-tissue to bone fixation in the | ||||
| shoulder, foot and ankle, knee, hand | ||||
| and wrist, elbow, and hip in | ||||
| skeletally mature pediatric and adult | ||||
| patients. It is indicated for use in the | ||||
| following procedures: 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, Hallux | ||||
| Valgus Reconstruction, Mid-foot | ||||
| Reconstruction, | ||||
| Metatarsal | ||||
| Ligament Repair/Tendon Repair |
Knee: Anterior Cruciate Ligament
Repair, Medial Collateral Ligament
Repair, Lateral Collateral Ligament
Repair, Patellar Tendon Repair,
Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis,
Quadriceps Tendon Repair,
Secondary or Adjunct Fixation for
ACL/PCL Reconstruction or Repair,
Meniscal Root Repair, MPFL
Repair/Reconstruction Hand/Wrist:
Scapholunate Ligament
Reconstruction, Ulnar or Radial
Collateral Ligament Reconstruction
Elbow: Biceps Tendon
Reattachment, Ulnar or Radial
Collateral Reconstruction, Lateral
Epicondylitis Repair Hip: Capsular
Repair, Acetabular Labral Repair,
Gluteus Medius Repair, Proximal
Hamstring Repair | Same |
| Operating
Principles | This product is used for orthopedic
surgery, which soft tissue fix such
as ligaments, tendons, and capsules
to bone. | This product is used for orthopedic
surgery, which soft tissue fix such
as ligaments, tendons, and capsules
to bone. | This product is used for orthopedic
surgery, which soft tissue fix such as
ligaments, tendons, and capsules to
bone. | Same |
| Material | PEEK anchor and non-absorbable
sutures | PEEK anchor and non-absorbable
sutures, needle | 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 | This product consists of an
implanted anchor, non-absorbable
suture, driver shaft and handle | Same |
| Product
Size | 3.75mm ~ 6.5mm | 2.3mm ~ 5.5mm | 4.75mm, 5.5mm, 6.5mm | 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 | 3Years | - | Same |
7
The Product Size of subject device is similar with the predicate device and the safety was evaluated as the performance bench test.
Reference device had been added to demonstrate the equivalency with the marketed device. This is to resolve that the product size (6.5mm) is larger than the product size range of unmodified device.
10. Substantially Equivalent Conclusion
Based on above, the subject device, Fix2Lock (PEEK Self Punching), is determined to be Substantially Equivalent (SE) to the Unmodified(Predicate) device, Fix2Lock (PEEK Self Punching) (K231322) ,in respect of safety and effectiveness.