Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical surgical anchor and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is described as an "anchor" intended for "fixation of suture (soft tissue) to bone" in various procedures like "Rotor Cuff Repair," indicating it is used to treat or stabilize a medical condition.

Diagnostic

No

The device description clearly states its purpose is for "fixation of suture (soft tissue) to bone" and "reattaching soft tissue to bone with sutures," which are surgical, not diagnostic, functions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical anchor manufactured from biodegradable materials and PEEK, intended for surgical implantation. It also mentions a driver for implantation and associated instruments. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description and Intended Use: The Fixone Hybrid Knotless Anchor is a surgical implant used to fix soft tissue to bone within the body. It is a physical device used during a surgical procedure, not for analyzing biological samples.

The description clearly indicates it's a surgical anchor for orthopedic procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor 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;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Product codes (comma separated list FDA assigned to the subject device)

MAI, MBI

Device Description

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.

This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 11 models. It provide non-sterile (user must sterilization before use).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Foot/Ankle, Knee, 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 test were performed. Bench testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device 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.

K192484

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.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

December 25, 2021

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

AJU Pharm Co., Ltd. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K203523

Trade/Device Name: Fixone Hybrid Knotless Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: November 19, 2021 Received: November 23, 2021

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

1

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 (OS) 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,

for

Laura C. Rose, Ph.D. 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) K203523

Device Name Fixone Hybrid Knotless Anchor

The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor 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;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

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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3

510(k) Summary

1. Applicant

Company : AJU Pharm Co.,Ltd. 1)
1. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
1. Tel : 82-31-765-4420
1. Fax : 82-31-602-7818
Prepared date : Nov. 09. 2020 5)
() Contact person : Peter Chung, 412-512-8802
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : Dec. 22. 2021
ರು) Submission type : Traditional
1. Prior related submissions : K192484 Kc type anchor

2. Device Information

Trade name : Fixone Hybrid knotless Anchor 1)
1. Common name : Fastener, Fixation, Biodegradable, Soft tissue
Regulation name : Single/multiple component metallic bone fixation appliances and accessories 3)
1. Product code : MAI, MBI
ട്) Regulation number : 888.3030
୧) Class of device : Class II
1. Panel : Orthopedic

3. The legally marketed device to which we are claiming equivalence

K192484, Aju Pharm Co., Ltd. / Fixone Biocomposite Anchor (Especially Kc Type)

4. Device description

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.

This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 11 models. It provide non-sterile (user must sterilization before use).

Product name	Instrument / 11 model codes including
Intended use	The instrument of make the hole in the bone.
Manufacturer	AJU Pharm Co.,Ltd. / Korea
Characteristic	This device is provided as Non-sterile and Reusable device.
This device is provided non-sterile. This device is user-sterilized.
Sterilization method	Autoclave / 132°C / 4min / 20 min dry

5. Intended Use :

The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow 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;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

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6. Performance data:

Bench test were performed. Bench testing included biocompatibility, mechanical testing 1) 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.

Test item	Requirements	Results
External surface	According to test methods of ASTM F2502 and USP
Measurement	Surface and measurement : Using vernier caliper, micrometer or a tape measure, should be within 5% of the dimension specified in specifications.
Insertion torque	Insertion torque : Drive the specimen into the test block(ASTM F1839) at a rate of 1r/min. Should not be less than 0.15Nm.
Fixation strength	Fixation : Apply a compressive load to the test specimen at a rate of 5mm/min. Should not be less than 100N.	Pass
Tensile strength	Tensile strength : measuring 10 suture threads with stretching. Should not be less than 34.5N
Torsional Test	Torsional test : Apply torsional load to the test specimen at a rate of 5r/min. This maximum torque should not be less than insertion torque.
Fixation anchor could endure movement of tissues and bones.
Arthrex did pull out and cyclic pull-out testing to support device performance.
Extraction test
pH	The difference should be 1.5 and less.
Potassium permanganate reducing substances	The difference of the consumption of potassium permanganate should be 2.0 mL and less.
Residue after evaporation	Record the weight of the residue should be 1.0mg and less.
Heavy metals	Any brown color produced within 10 minutes in the tube containing the extract of the prepared sample does not exceed that in the tube containing the standard lead solution	Pass
UV spectrum(250nm~350nm)	Maximum absorbance between 250 to 350 nm should be 0.1 and less.
Property	When observing it with the naked eye, test solution should be clear and have no foreign particles.
Pyrogen	Material-mediated pyrogens
ISO10993-11, USP39	Pass
Shelf life testing	To make shelf life time, my company set Real-time equivalent (RTE) and Accelerated aging
temperature, Taa as per AAMI TIR17 and ASTM F 1980-02.
Aging temperature: 55±2°C, aging time: 229 days	Pass
Shelf life testing(Real-time)	This aims to verify that this product is valid for 5 years (60 months) by testing physicochemical
changes and packaging of the materials and the product at six times points before real time aging
(0 year), middle real time aging (1 year, 2 years, 3 years, 4years) and after real time aging (5
years) on the evaluation of validity and safety for medical appliances by ISO 11607-1:2006, ISO
11607-2:2006.	Pass
EO sterilization Validation
(EO residual test in EO
sterilization Validation
report)	ISO11135(2014)	Pass

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2) Biocompatibility

#	Test item	Test method / Test criteria	Test result
1	Cytotoxicity	ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
2	Maximization test for delayed hypersensitivity	ISO 10993-10, Tests for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass
3	Intracutaneous reactivity	ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous(Intradermal)Reactivity Test	Pass
4	Acute Systemic toxicity	ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity	Pass
5	Material-mediated Pyrogen	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
6	Sub acute Systemic toxicity	ISO 10993-11 Test for systemic toxicity, Systemic toxicity	Pass
7	Bacterial reverse mutation test	ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test	Pass
8	Mammalian erythrocyte micronucleus test	ISO 10993-3, Genotoxicity test OECD 474, Mammalian erythrocyte micronucleus test	Pass
9	Implantation test	ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone	Pass

6

	Suture
#	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	Maximization test
for delayed
hypersensitivity	ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity	Pass
3	Intracutaneous
reactivity	ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous
(Intradermal)Reactivity Test	Pass
4	Acute Systemic
toxicity	ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity	Pass
5	Material-mediated
Pyrogen	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
6	Sub acute Systemic
toxicity	ISO 10993-11 Test for systemic toxicity, Systemic toxicity	Pass
7	Bacterial reverse
mutation test	ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test	Pass
8	Mammalian
erythrocyte
micronucleus test	ISO 10993-3, Genotoxicity test OECD 474, Bacterial reverse mutation test	Pass
9	Implantation test	ISO 10993-6, Tests for local effects after implantation(4weeks)	Pass
		ISO 10993-6, Tests for local effects after implantation(12weeks)	Pass
10	Biological risk
assessment	This assessment and evaluation plan focuses on the requirements of ISO
10993-1:2009 - Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process, EN ISO
14971:2012 - Medical devices – Application of risk management to
medical devices, FDA General Program Memorandum #G95-1, Use of
International Standard ISO-10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, and the European Union Medical
Device Directive 93/42/EEC.1,2,3,4 It examines the components used in
the device, information on the device materials in the literature, and the
history of safe and effective use of the device materials in humans.	-

Tip
#	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

7

| 2 | Maximization test
for delayed
hypersensitivity | ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity | Pass |
|---|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------|
| 3 | Intracutaneous
reactivity | ISO 10993-10, Tests for irritation and skin sensitization,
Intracutaneous(Intradermal)Reactivity Test | Pass |
| 4 | Acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity | Pass |
| 5 | Material-mediated
Pyrogen | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 6 | Sub acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Systemic toxicity | Pass |
| 7 | Bacterial reverse
mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| 8 | Mammalian
erythrocyte
micronucleus test | ISO 10993-3, Genotoxicity test OECD 474, Bacterial reverse mutation test | Pass |
| 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test
methods for implantation in bone | Pass |

Suture(White(B), Black(90%)/White(10%), Black(50%)/White(50%), Black(10%)/White(90%), Black(100%)) (Newly added information)

#	Test item	Test method / Test criteria
1	Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity	Pass
2	Maximization test
for delayed
hypersensitivity	ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity	Pass
3	Intracutaneous
reactivity	ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous
(Intradermal)Reactivity Test	Pass
4	Acute Systemic
toxicity	ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity	Pass
5	Material-mediated
Pyrogen	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
6	Sub chronic
Systemic toxicity	ISO 10993-11 Test for systemic toxicity, Sub chronic Systemic toxicity	Pass

8

| 7 | Bacterial reverse
mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
|---|-----------------------------------------------|-------------------------------------------------------------------------------------|------|
| 8 | Mammalian
erythrocyte
micronucleus test | ISO 10993-2, Genotoxicity test OECD 474, Mammalian erythrocyte
micronucleus test | Pass |
| 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation(4weeks) | Pass |
| | | ISO 10993-6, Tests for local effects after implantation(12weeks) | Pass |

Driver shaft (Stainless steel 304)

#	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	Intracutaneous
reactivity test	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass
3	Maximization
sensitization	ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass

Endotoxin test

#	Test item	Test method / Test criteria	Test result
1	Endotoxin	USP 43 , Bacterial endotoxin test (LAL)	Pass

Endotoxin level and EO sterilization will be monitored In an alternative plan to batch testing.

The performance tests demonstrated that Fixone Hybrid Knotless Anchor performs in a substantially equivalent manner to the predicate device.

7. Predicate device comparison table

Manufacturer	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	Remark
510(k) No.	K192484	K203523	N/A
Indication for use	The Fixone Biocomposite Anchors are
intended for fixation of suture (soft
tissue) to bone in the shoulder,
foot/ankle, knee and elbow 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;

Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis; | The Fixone Hybrid Knotless Anchors are
intended for fixation of suture (soft
tissue) to bone in the shoulder,
foot/ankle, knee and elbow 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;

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PEEK : This is the only different part between subject and predicate device.

8. Conclusion

The device is investigated for function to compare the operation of function between Fixone Hybrid Knotless Anchor

10

and predicate devices.

The subject device was made very similarly with the kc type anchor in K192484. The material of tip is the only different thing. Biodegradable material, PLGA + β-TCP was used in the tip of KC type. Non-biodegradable material, PEEK was used in the tip of subject device. Other materials, mechanical properties, appearance and using methods are all same.

The tip of KP type of PEEK is non-biodegradable material that compared to PLGA + β-TCP.

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 Hybrid Knotless Anchor is substantially equivalent to the legally marketed predicate device.