(30 days)
No
The device description and performance studies focus on the mechanical properties and materials of a suture anchor for orthopedic surgery, with no mention of AI or ML.
Yes
The device is described as an implant used in orthopedic surgery for fixation of soft tissue to bone, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an implant used for fixation of soft tissue to bone during orthopedic surgery, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the product is an "implant part is made of PEEK" and "consists of 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 clearly states "fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery". This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an implant made of PEEK with suture, used for fixing soft tissue to bone during surgery. This is a surgical device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (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 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 population 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)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
June 7, 2023
Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasandigital 2-ro, Geumcheon-gu Seoul, 08507 Korea, South
Re: K231322
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: May 8, 2023 Received: May 8, 2023
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
1
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 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
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231322
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Date of Submission: 2023.06.07
01. Applicant
OSTEONIC Co., Ltd.
405Ho, 505-2Ho, 505-3Ho, 508Ho, 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 TEL: +82-2-6902-8456 FAX: +82-2-6902-8401 Email: dakham@osteonic.com
02. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #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 (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: K202763 Device Name: Fix2Lock (PEEK Self Punching) Manufacturer: Osteonic Co., Ltd.
05. Reference Device
510(k) Number: K081511 Device Name: 2.0 PK Suture anchor T and 2.0 PK Suture anchor S Manufacturer: Smith &Nephew, Inc.
510(k) Number: K202806
Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic Co., Ltd.
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.
4
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 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 population 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
5
09. Comparison of Technological Similarities and Differences Table 1: Substantial Equivalence Comparison
| Product
Name | Modified(Subject) Device
Fix2Lock (PEEK Self
Punching), K231322 | Unmodified(Predicate)
Device
Fix2Lock (PEEK Self
Punching), K202763 | REFERENCE Device
2.0 PK Suture anchor T and
2.0 PK Suture anchor S,
K081511 | 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 and knees. | The 2.0 PK Suture Anchor T
and 2.0 PK Suture Anchor S
is intended for use for
reattachment of soft tissue
to bone for the following
indication:
Shoulder: Capsular
stabilization - Bankart
repair, Anterior shoulder
instability, Slap lesion repair,
Capsular shift or
capsulolabral
reconstruction,
Acromilavicular separation
repairs, Deltoid repairs,
Rotator cuff repairs and
Biceps tenodesis
Foot/ankle: Hallux valgus
repairs, Medial or lateral
instability
repairs/reconstruction,
Achilles tendon
repairs/reconstruction, Mid-
foot reconstruction,
Metatarsal ligament/tendon
repairs/reconstruction and
Bunionectomy.
Elbow, Wrist, and Hand:
Biceps tendon
reattachment, Ulnar or radial
collateral ligament
reconstruction, Lateral
epicondylitis repair, and
Scapholunate ligament
reconstruction.
Knee: Extra-capsular
repairs - Medial collateral
ligament, Lateral collateral
ligament, Posterior oblique
ligament, Patellar
realignment and tendon
repairs - Vastus medialis
obliquus advancement and
Iliotibial band tenodesis. | 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. | Same | |
| Material | PEEK anchor and non-
absorbable sutures,
needle | PEEK anchor and non-
absorbable sutures. | PEEK. Non-absorbable
suture, Stainless steel
needle. | 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 | The 2.0 PK Suture Anchor T
and the 2.0 PK Suture
Anchor S consist of a non-
absorbable suture anchor
with attached non-
absorbable suture(s)
preassembles to a stainless
steel insertion device, and is
provided sterile, for single
use only. Both anchor
models achieve fixation via
ribbed/threaded design
characteristics that are
consistent with the repair of
soft tissue to bone. | Same |
| Product
Size | 2.3mm, 4.5mm, 4.8mm,
5.5mm type | 4.5mm, 5.5mm type | 2.03mm | Similar |
| Sterilization | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Sterile | Same |
| Single Use/
Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | 1 EA / BOX | Same |
| Shelf life | 3Years | 5Years | | Similar |
6
K231322
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 needles are not applied for 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) (K202763) ,in respect of safety and effectiveness.