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, lliotibial Band Tenodesis;

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

The following indications are for the S and SL type anchors only:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Hip: Capsular repair, Acetabular Labral repair

Device Description

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

B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.

Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.

SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.

S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist

The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone.

Devices are provided sterile. Single use only.

AI/ML Overview

The provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) submission to the FDA. This submission aims to demonstrate substantial equivalence to previously cleared devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document discusses:

Device Description: What the Fixone Biocomposite Anchor is, its components (PLGA copolymer and β-TCP anchor, UHMWPE suture), and how it's implanted.
Intended Use: Fixation of suture (soft tissue) to bone in various anatomical locations (shoulder, foot/ankle, knee, elbow, hand/wrist, hip).
Predicate Device Comparison: A detailed table comparing the subject device to several predicate devices (K171299, K192032, K192484, K213008) across various attributes like indications for use, materials, dimensions, fixation mechanism, suture characteristics, and sterilization.
Performance Data: Mentions "Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices."

Crucially, there is no mention of:

AI/ML components: The device is a physical biocomposite anchor, not a software algorithm.
Clinical study or diagnostic performance metrics: The performance data refers to bench testing for physical and material properties, not clinical outcomes, sensitivity, specificity, or AUC for a diagnostic tool.
Ground truth, expert readers, sample sizes for AI models, or MRMC studies. These are concepts relevant to evaluating AI/ML diagnostic or predictive devices, which the Fixone Biocomposite Anchor is not.

Therefore, I cannot fulfill the request as the provided input does not contain the necessary information about acceptance criteria and a study proving an AI/ML device's performance. The device described is a traditional medical implant, and its evaluation focuses on physical and biological equivalence, not AI performance.

Summary

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June 9, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K230892

Trade/Device Name: Fixone Biocomposite 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: March 31, 2023 Received: March 31, 2023

Dear Mr. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

Jesse Muir, 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) K230892

Device Name Fixone Biocomposite Anchor

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, lliotibial Band Tenodesis;

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

The following indications are for the S and SL type anchors only:

Hand Wrist. Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Hip: Capsular repair, Acetabular Labral repair

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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510(k) Summary

1. Applicant

1. Company : AJU Pharm Co.,Ltd.
1. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
1. Tel : 82-31-765-4420
1. Fax : 82-31-602-7818
Preparation date : Mar. 31, 2023 5)
୧) Contact person : Peter Chung, 412-512-8802
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : June 8, 2023
1. Submission type : Special
1. Prior related submissions : K171299, K192484, K192032, K203523
1. Submission Number : K230892

2. Device Information

Trade name : Fixone Biocomposite Anchor 1)
Common name : Fastener, Fixation, Biodegradable, Soft Tissue 2)
1. Regulation name : Single/multiple component metallic bone fixation appliances and accessories.
1. Product code : MAI
1. Regulation number : 888.3030
1. Class of device : Class II
1. Panel : Orthopedic

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

K203523, Aju Pharm Co., Ltd. / Fixone hybrid knotless anchor (Only for UHMWPE suture)

Reference devices

K171299, Aju Pharm Co., Ltd. / Fixone Biocomposite Anchor

K192484, Aju Pharm Co., Ltd. / Fixone Biocomposite Anchor (Special submission of K171299)

K192032, Aju Pharm Co., Ltd. / Fixone Biocomposite Small Anchor

4. Device description

B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.

Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.

SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.

S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist

Devices are provided sterile. Single use only.

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5. Intended 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, lliotibial Band Tenodesis;

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

The following indications are for the S and SL type anchors only:

Hip: Capsular repair, Acetabular Labral repair

6. Predicate device comparison table

Manufacturer	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	Remark
510(k) No.	K171299	K192032	K192484	K213008	N/A

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Indication foruse	The Fixone BiocompositeAnchors are intended forfixation of suture (softtissue) to bone in theshoulder, foot/ankle,knee and elbow in thefollowing procedures:Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair,Capsular Shift orCapsulolabralReconstruction;Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair;Knee: Medial CollateralLigament Repair, LateralCollateral LigamentRepair, Posterior ObliqueLigament Repair, IliotibialBand Tenodesis;Elbow: Biceps TendonReattachment, Ulnar orRadial Collateral LigamentReconstruction.	The Fixone BiocompositeSmall Anchor are intendedto be used for suture (softtissue) fixation to bone inthe foot, ankle, knee,hand, wrist, elbow,shoulder, and hip.Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair,Capsular Shift orCapsulolabralReconstructionFoot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair, MetatarsalLigament Repair, HalluxValgus reconstruction,digital tendon transfers,Mid-foot reconstructionKnee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Patellar Tendon Repair,Posterior ObliqueLigament Repair, IliotibialBand TenodesisHand/Wrist: ScapholunateLigament Reconstruction,Carpal LigamentReconstruction,Repair/Reconstruction ofcollateral ligaments,Repair of Flexor andExtensor Tendons at thePIP, DIP, and MCP jointsfor all digits, digital tendontransfersElbow: Biceps TendonReattachment, Ulnar orRadial Collateral LigamentReconstructionHip: Capsular repair,Acetabular Labral repair	The Fixone BiocompositeAnchors are intended forfixation of suture (softtissue) to bone in theshoulder, foot/ankle,knee and elbow in thefollowing procedures:Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair,Capsular Shift orCapsulolabralReconstruction;Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair;Knee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Posterior ObliqueLigament Repair, IliotibialBand Tenodesis;Elbow: Biceps TendonReattachment, Ulnar orRadial Collateral LigamentReconstruction.	The Fixone BiocompositeAnchors are intended forfixation of suture (softtissue) to bone in theshoulder, foot/ankle,knee and elbow in thefollowing procedures:Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair,Capsular Shift orCapsulolabralReconstruction;Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair;Knee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Posterior ObliqueLigament Repair, IliotibialBand Tenodesis;Elbow: Biceps TendonReattachment, Ulnar orRadial Collateral LigamentReconstruction.The following indicationsare for the S and SL typeanchors only:Hand/Wrist: ScapholunateLigament Reconstruction,Carpal LigamentReconstruction,Repair/Reconstruction ofcollateral ligaments,Repair of Flexor andExtensor Tendons at thePIP, DIP, and MCP jointsfor all digits, digital tendontransfersHip: Capsular repair,Acetabular Labral repair	Similar
Classificationname	Fastener, Fixation,Biodegradable, Soft Tissue	Fastener, Fixation,Biodegradable, Soft Tissue	Fastener, Fixation,Biodegradable, Soft Tissue	Fastener, Fixation,Biodegradable, Soft Tissue	Same
Trade name	Fixone BiocompositeAnchor	Fixone Biocomposite SmallAnchor	Fixone BiocompositeAnchor	Fixone BiocompositeAnchor	Same

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Manufacturer	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	Remark
Model/type	80 model codes includingBAB-45001a	9 model codes includingSAB-30001a	161 model codes includingBAB-45001a	211 model codes includingBAB-45002ah	N/A
Productconfiguration	Driver	Driver	Driver	Driver
	Anchor	Anchor	Anchor	Anchor	Same
	Suture	Suture	Suture	Suture
Material	PLGA(70%) + B-TCP(30%)	PLGA(70%) + B-TCP(30%)	PLGA(70%) + B-TCP(30%)	PLGA(70%) + B-TCP(30%)	Same
Anchor
Outsidediameter	4.5mm/4.75mm/5.5mm/5.75mm/6.5mm	3.0mm	3.0mm/4.5mm/4.75mm5.5mm/5.75mm/6.5mm	3.0mm/4.5mm/4.75mm5.5mm/5.75mm/6.5mm	Similar
Length ofanchor	14.6mm/15mm/15.7mm/16mm/16.8mm	11.9mm	11.9mm/14.6mm/15mm/15.7mm/16mm/16.5mm/16.8mm	11.9mm/14.6mm/15mm/15.7mm/16mm/16.5mm/16.8mm/17mm/17.7mm	Similar
Fixationmechanism	Anchor holds soft tissueand suture. Anchor andsuture could endure thetension of moving duringdegradation of anchor.	Anchor holds soft tissueand suture. Anchor andsuture could endure thetension of moving duringdegradation of anchor.	Anchor holds soft tissueand suture. Anchor andsuture could endure thetension of moving duringdegradation of anchor.	Anchor holds soft tissueand suture. Anchor andsuture could endure thetension of moving duringdegradation of anchor.	Same
Inner diameter	Same as subject	Same as subject	Same as subject	Same as predicate	Same
Degradation	Average 15% to 4 weeks	Average 15% to 4 weeks	Average 15% to 4 weeks	Average 15% to 4 weeks	Same
Suture
Absorbable	Non-absorbable	Non-absorbable	Non-absorbable	Non-absorbable	Same
Suturediameter	0.50~0.599 (USP size 2)	0.35~0.399 (USP size 0)	0.50~0.599 (USP size 2)	0.35~~0.399 (USP size 0)0.50~~0.599 (USP size 2)	Similar
Material	Polyethylene	Polyethylene	Polyethylene	Polyethylene (UHMWPE)	Same
Colorant	Blue / Green / Violet	Blue / Green / Violet	Blue / Green / Violet	Blue / Green / Violet /Black	Similar
Sterilization	EO Gas sterilizationAccording to ISO 11135:2014	EO Gas sterilizationAccording to ISO 11135:2014	EO Gas sterilizationAccording to ISO 11135:2014	EO Gas sterilizationAccording to ISO 11135:2014	Same
Biodegradable	No	No	No	No	Same
Principle ofoperation	Manual	Manual	Manual	Manual	Same
Shelf-life	5 years	5 years	5 years	5 years	Same
Inserterconfiguration	Shaft that holds theanchor from inside withsuture	Shaft that holds theanchor from inside withsuture	Shaft that holds theanchor from inside withsuture	Shaft that holds theanchor from inside withsuture	Same

K192032, Fixone Biocomposite Small Anchor could be used in smaller surgery spot like hand, wrist and hip. Differences of intended use was just come from device size.

The differences between predicate and subject device which could effect the performance of device is thread and suture.

Thread – Added new performance test data of dual-threaded anchors. KcN type is from the Kc type. KcN type anchor has same design with Kc type anchor except only the thread. BN type anchor. The eyelet part of BN type is different with the eyelet of N type anchor. BN type has same design with N type anchor except only the eyelet design.

Suture – Added new performance test data of only UHMWPE suture. (Previously cleared in K203523)

These differences could be explained with new test report and also could be explained by predicate devices because all of these predicate devices were made with same manufacturing process of subject device.

7. Performance data:

Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices.

8. Conclusion

The device is investigated for function to compare the operation of function between Fixone Biocomposite Anchor and prior related devices.

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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 Biocomposite Anchor is substantially equivalent to the legally marketed predicate device.

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.