(224 days)
No
The description focuses on the mechanical properties and materials of a suture anchor, with no mention of AI or ML.
No
While the device assists in reattaching soft tissue to bone, its primary function is mechanical stabilization and fixation, rather than direct treatment or rehabilitation of a disease or medical condition. It facilitates the body's natural healing process rather than acting as a therapeutic agent itself.
No
Explanation: The device is a suture anchor system used to reattach soft tissue to bone in orthopedic surgical procedures. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is a "handled insertion device" and includes physical components like sutures and a handle, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reattach soft tissue to bone in orthopedic surgical procedures." This is a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implant (suture anchor) made of UHMWPE and sutures, pre-loaded on an insertion device. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to diagnose, monitor, or screen for diseases or conditions by examining samples.
Therefore, this device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
Product codes
MBI
Device Description
Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.
The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue (ligaments, tendons, joint capsules)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures
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 test were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Anchor Testing:
- Insertion Strength: Insert each anchor with 5mm/min rate into 10pcf/40pcf combined urethane block. (Results: Pass)
- Pull-out: Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined urethane block. (Results: Pass)
- Fatigue test: Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 cycles from 10pcf/40pcf combined urethane block. (Results: Pass)
Suture (USP 0, UHMWPE) Testing:
- Appearance: The test article shall be no damage to the appearance in visual inspection. (Results: Pass)
- Length: The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm. (Results: Pass)
- Tensile Strength: For USP 0 size suture, tensile strength must be larger than 2.16 kgf. (Results: Pass)
- Needle Attachment: For USP 0 size suture, needle attachment must be larger than 1.50 kgf. (Results: Pass)
Suture (USP 2, UHMWPE) Testing:
- Length: The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm. (Results: Pass)
- Tensile Strength: For USP 2 size suture, tensile strength must be larger than 3.52 kgf. (Results: Pass)
Suture (USP 0, USP 2, UHMWPE) Testing:
- Appearance: The test article shall be no damage to the appearance in visual inspection. (Results: Pass)
- Diameter: For USP 0 size suture, diameter must be within 0.35
0.399mm. For USP 2 size suture, diameter must be within 0.500.599mm. (Results: Pass) - Tensile strength: With 25~35cm/min, record the load-displacement curves and maximum load. (N) (Results: Pass)
Biocompatibility (UHMWPE + PET and Only UHMWPE):
- Cytotoxicity (ISO 10993-5) (Results: Pass)
- Systemic toxicity test (ISO 10993-11) (Results: Pass)
- Pyrogen Test (ISO 10993-11) (Results: Pass)
- Intracutaneous reactivity test (ISO 10993-10) (Results: Pass)
- Maximization sensitization (ISO 10993-10) (Results: Pass)
- Genotoxicity test (ISO 10993-3) (Results: Pass)
- Implantation test (ISO 10993-6) (Results: Pass)
- Hemolysis test (ISO 10993-4) (Results: Pass)
- Subchronic toxicity (ISO 10993-11) (Results: Pass)
Endotoxin test (USP 43 , Bacterial endotoxin test (LAL)) (Results: Pass).
The performance tests demonstrated that Fixone All Suture Anchor performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
March 23, 2023
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: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The seal is a stylized representation of a human figure, and the text is in a bold, sans-serif font. The logo is used to identify the FDA, a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
AJU Pharm Co., Ltd. % Peter Chung 300, Atwood Street Pittsburgh, Pennsylvania 15213
Re: K222423
Trade/Device Name: Fixone All Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 21, 2023 Received: February 21, 2023
Dear Peter Chung:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sara S. Thompson -S
For
Laurence D. Coyne. Ph.D. 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
2
Indications for Use
510(k) Number (if known) K222423
Device Name Fixone All Suture Anchor
Indications for Use (Describe)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.
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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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510(k) Summary
[as required by 807.92(c)]
1. Applicant
- Company : AJU Pharm Co.,Ltd. 1)
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
- Tel : 82-31-765-4420 3)
- Fax : 82-31-602-7818 4)
- Prepared date : March 22, 2023 5)
-
- Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : August 08, 2022
2. Device Information
- Trade name : Fixone All Suture Anchor 1)
-
- Common name : Non-absorbable Suture Anchor
- Regulation name : Fastener, Fixation, Nondegradable, Soft tissue 3)
-
- Product code : MBI
-
- Regulation number : 888.3040
- Class of device : Class II 6)
-
- Panel : Orthopedic
3. The legally marketed device to which we are claiming equivalence
K192709 AJU Pharm Co., Ltd. / Fixone All Suture Anchor
Reference Devices
K192032 AJU Pharm Co., Ltd. / Fixone Biocomposite Small Anchor K133224 CONMED Co. / Y-Knot RC All-Suture Anchor K110145 Biomet, Inc. / Biomet Sports Medicine Juggerknot Soft Anchor
4. Device description
Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.
The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively."
5. Indications for Use :
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
6. Performance data:
- Bench test were performed. Bench testing included biocompatibility, mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
4
Anchor
| Test item | Requirements | Results |
|---|---|---|
| Insertion Strength | Insert each anchor with 5mm/min rate into 10pcf/40pcf combined | |
| urethane block. | ||
| Pull-out | Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined | |
| urethane block. | Pass | |
| Fatigue test | Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 | |
| cycles from 10pcf/40pcf combined urethane block. |
FAS-1652802iw model was used for this test report shows the performance of Js type all suture anchor that has smaller length of flat suture. This performance test was done with FDA cleared device (K133224).
Anchor
| Test item | Requirements | Results |
|---|---|---|
| Pull-out | Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined | |
| urethane block. | Pass | |
| Fatigue test | Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 | |
| cycles from 10pcf/40pcf combined urethane block. | Pass |
FAM-7615802fg model was used for this test report shows the performance of JM type all suture anchor that has smaller length of flat suture. This performance test was done with FDA cleared device (K110145).
Suture (USP 0, UHMWPE)
| Test item | Requirements | Results |
|---|---|---|
| Appearance | The test article shall be no damage to the appearance in visual | |
| inspection. | ||
| Length | The length of suture was measured while the strand is laid out smooth, | |
| without tension, on a plane surface: the length of the strand is not less | ||
| than 95.0 percent of 750mm. | Pass | |
| Tensile Strength | For USP 0 size suture, tensile strength must be larger than 2.16 kgf. | |
| Needle Attachment | For USP 0 size suture, needle attachment must be larger than 1.50 kgf. |
Suture (USP 2, UHMWPE)
| Test item | Requirements | Results |
|---|---|---|
| Length | The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm. | Pass |
5
| Tensile Strength | For USP 2 size suture, tensile strength must be larger than 3.52 kgf. |
|---|---|
| ------------------ | ----------------------------------------------------------------------- |
Suture (USP 0, USP 2, UHMWPE)
| Test item | Requirements | Results |
|---|---|---|
| Appearance | The test article shall be no damage to the appearance in visual | |
| inspection. | Pass | |
| Diameter | For USP 0 size suture, diameter must be within 0.35~0.399mm. | |
| For USP 2 size suture, diameter must be within 0.50~0.599mm. |
Suture (USP 0, USP 2, UHMWPE)
| Test item | Requirements | Results |
|---|---|---|
| Tensile strength | With 25~35cm/min, record the load-displacement curves and maximum | |
| load. (N) | Pass |
2) Biocompatibility
UHMWPE + PET
| # | Test item | Test method / Test criteria | Test result |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| 2 | Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| 5 | Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| 6 | Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| 7 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| 8 | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
| 9 | Subchronic toxicity | ISO 10993-11 Tests for systemic toxicity | Pass |
Only UHMWPE
| # | Test item | Test method / Test criteria | Test result |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| 2 | Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| 5 | Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| 6 | Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
6
| 7 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test
methods for implantation in bone | Pass |
|---|---------------------|-------------------------------------------------------------------------------------------------------------------|------|
| 8 | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of
tests for interactions with blood | Pass |
| 9 | Subchronic toxicity | ISO 10993-11 Tests for systemic toxicity | Pass |
The performance tests demonstrated that Fixone All Suture Anchor performs in a substantially equivalent manner to the predicate device.
| # | Test item | Test method / Test criteria | Test result |
|---|---|---|---|
| 1 | Endotoxin test | USP 43 , Bacterial endotoxin test (LAL) | Pass |
Endotoxin level and EO sterilization will be monitored in an alternative plan to batch testing.
7. Predicate device comparison table
| Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark |
|---|---|---|---|
| 510(k) No. | K192709 | N/A | |
| Intended Use | The non-absorbable suture anchors are | ||
| intended to reattach soft tissue to bone | |||
| in orthopedic surgical procedures. The | |||
| Fixone All Suture Anchors may be used in | |||
| either arthroscopic or open surgical | |||
| procedures. After the suture strands are | |||
| anchored to the bone, they may be used | |||
| to reattach soft tissue, such as ligaments, | |||
| tendons, or joint capsules to the bone. In | |||
| conjunction with appropriate | |||
| postoperative immobilization throughout | |||
| the healing period, the suture anchor | |||
| systems stabilize the damaged soft | |||
| tissue. | The non-absorbable suture anchors are | ||
| intended to reattach soft tissue to bone in | |||
| orthopedic surgical procedures. The | |||
| Fixone All Suture Anchors may be used in | |||
| either arthroscopic or open surgical | |||
| procedures. After the suture strands are | |||
| anchored to the bone, they may be used | |||
| to reattach soft tissue, such as ligaments, | |||
| tendons, or joint capsules to the bone. In | |||
| conjunction with appropriate | |||
| postoperative immobilization throughout | |||
| the healing period, the suture anchor | |||
| systems stabilize the damaged soft tissue. | Identical | ||
| Classification | |||
| name | Fastener, Fixation, Nondegradable, Soft | ||
| Tissue | Fastener, Fixation, Nondegradable, Soft | ||
| Tissue | Identical | ||
| Trade name | Fixone All Suture Anchor | Fixone All Suture Anchor | N/A |
| Model/type | 14 model codes including FAS-1652802ew | 61 model codes including FAS-1652802ew | N/A |
| Appearance | Image: Fixone All Suture Anchor | Image: Fixone All Suture Anchor | Identical |
| Product | |||
| configuration | Driver | ||
| Suture Anchor | Driver | ||
| Suture Anchor | |||
| Needle for JM type | Different | ||
| Material | Non-absorbable Suture | Non-absorbable Suture | Identical |
| Suture | |||
| Absorbable | Non-absorbable | Non-absorbable | Identical |
| Suture diameter | 0.50~0.599 (USP size 2) | 0.50~0.599 (USP size 2) | |
| 0.30~0.399 (USP size 0) | Different | ||
| Material | UHMWPE, PET | UHMWPE, PET | Identical |
| Sterilization | EO Gas sterilization | ||
| According to ISO 11135: 2014 | EO Gas sterilization | ||
| According to ISO 11135: 2014 | Identical | ||
| Biodegradable | Yes | Yes | Identical |
7
| Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark |
|---|---|---|---|
| Principle of operation | Manual | Manual | Identical |
| Shelf-life | 5 years | 5 years | Identical |
Difference #1 Product configuration
JM type that include needle are added. This needle intended to penetrate suture to soft tissue.
The needle included in the JM type is identical to the needle included in the K192032 product, and the production process is also the same.
Difference #2 Suture Diameter
USP 0 size suture is added. Thinner suture could cause the early break than thicker suture. So, we have done the performance test report of USP 0 size suture.
9. Conclusion
The device is investigated for function to compare the operation of function between Fixone All Suture Anchor and predicate devices.
Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.
Therefore, it is concluded that Fixone All Suture Anchor is substantially equivalent to the legally marketed predicate device.