Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

• K Number: K231002
• Device Name: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
• Manufacturer: Suzhou Endophix Co., Ltd.
• Date Cleared: 2023-06-07 ( 61 days)
• Product Code: MBI
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K093228 , K101823 , K203495 , K140855 , K061863 , K063479 , K093897 , K121018
• Predicate For: N/A

Intended Use

The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart lesion repair -SLAP lesion repair -Acromioclavicular separation repair -Rotator cuff tear repair -Capsular shift or capsulolabral reconstruction -Biceps tenodesis -Deltoid repair Foot/Ankle: -Hallux Valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repair/reconstruction Elbow: -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Biceps tendon reattachment Knee: -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Iliotibial band tenodesis -Patellar realignment and tendon repair Vastus medialis obliquus advancement

The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair Foot/Ankle: - -Hallux Valgus reconstruction - -Medial stabilization - -Lateral stabilization - -Achilles tendon repair - -Mid-foot reconstruction - -Metatarsal ligament/ tendon repair - -Bunionectorny Elbow: - -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment - -Lateral epicondylitis repair Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar/Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair - -Lateral collateral ligament repair - -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repairs - -Anterior cruciate ligament repair (4.75-5.5mm anchors only) - -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip: -Capsular Repair -Acetabular labral repair - -Proximal hamstring repair (4.75-5.5mm anchors only) - -Gluteus Medius Repair (4.75-5.5mm anchors only)

The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: - -Rotator cuff repair -Bankart repair -SLAP lesion repair -Biceps tenodesis -Acromioclavicular separation repair -Deltoid repair -Capsular shift or capsulolabral reconstruction Foot/Ankle: - -Lateral stabilization -Medial stabilization -Achilles tendon repair -Metatarsal ligament repair -Hallux valgus reconstruction -Digital tendon transfers -Mid-foot reconstruction Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Patellar tendon repair -Posterior oblique ligament repair -Iliotibial band tenodesis 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 Elbow: -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction Hip: -Capsular repair -Acetabular labral repair

The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: -Bankart repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only) Elbow: -Ulnar or radial collateral ligament reconstructions -Biceps tendon reattachment - -Lateral epicondylitis repair (2.9-4.5mm anchors only) Hand/ Wrist: -Scapholunate ligament reconstruction -Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only) -Radial collateral ligament reconstruction (2.9-4.5mm anchors only) -Carpal ligament reconstruction (2.5mm anchors only) -Repair/Reconstruction of collateral ligaments (2.5mm anchors only) -Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only) -Digital tendon transfers (2.5mm anchors only) Knee: -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs Hip: (2.9-4.5mm anchors only) -Acetabular labral repair -Capsular repair

The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: - Shoulder: - -Bankart lesion repair - -SLAP lesion repair - -Acromioclavicular separation repair - -Rotator cuff tear repair - -Capsular shift or capsulolabral reconstruction - -Biceps tenodesis - -Deltoid repair - -Anterior shoulder instability (3.7mm anchors only) Foot/ Ankle: - -Hallux Valgus repair - -Medial or lateral instability repair - -Midfoot reconstruction - -Metatarsal ligament/tendon repair/reconstruction - -Achilles tendon repair/reconstruction - -Bunionectomy (3.7mm anchors only) Elbow: - -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only) - Hand/Wrist: - -Scapholunate ligament reconstruction - -Ulnar collateral ligament reconstruction - -Radial collateral ligament reconstruction Knee: - -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair - -Iliotibial band tenodesis - -Patellar tendon repair Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction

Device Description

All Javelot PEEK suture anchors are preassembled onto an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a polyetheretherketone (PEEK) material with a screw-in, push-in (with or without lock-in) design. The sutures are offered in non-absorbable USP braid ultrahigh molecular weight polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rod is offered in stainless steel material, the insertion handle is offered in acrylonitrile butadiene Styrene copolymers (ABS) material. Javelot PEEK suture anchors come in various configurations, including: with attached nonabsorbable suture(s). Javelot PEEK suture anchors are non-absorbable, provided sterile, for single use only.

AI/ML Overview

This is a 510(k) premarket notification for multiple suture anchors. The document focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. It does not describe a clinical study of the device or an AI/human-in-the-loop study.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in the format usually seen for clinical studies or AI product validations. Instead, it states that "Non-clinical bench tests were conducted in support of the substantial equivalence determination" and that the "testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device."

The types of mechanical tests performed are listed, with the implication that the new devices met the performance characteristics expected for substantial equivalence:

Parameter	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Insertion Testing	Performance comparable to predicate devices	Conducted; passed (implied by conclusion of substantial equivalence)
Pullout Testing	Performance comparable to predicate devices	Conducted; passed (implied by conclusion of substantial equivalence)
Component Interconnection Testing	Performance comparable to predicate devices	Conducted; passed (implied by conclusion of substantial equivalence)
Fatigue Testing	Performance comparable to predicate devices	Conducted; passed (implied by conclusion of substantial equivalence)
Biocompatibility	In accordance with ISO 10993-1: 2018	Evaluated and deemed compliant
Bacterial Endotoxin	To meet endotoxin limit specifications	Determined using LAL testing to meet specifications
Sterilization	SAL of 10^-6 (validated according to ISO 11135:2014)	Validated to a SAL of 10^-6
Shelf-life	5 Years (evaluated by accelerated aging test)	Evaluated to be 5 years
MRI Safety	MR safe (per ASTM F2503)	Labeled MR safe

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench tests. It does not specify sample sizes for these tests, nor does it refer to "test sets" in the context of human data or AI validation. Therefore, provenance information like country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or described in this document. This is a medical device (suture anchor) and not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable since the device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical bench tests, "ground truth" would be established by standardized testing methods and measurement against predefined performance metrics (e.g., pullout strength, fatigue limits) according to relevant ASTM and ISO standards. This is not comparable to ground truth in a clinical or AI study.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI system.

9. How the ground truth for the training set was established

This is not applicable as the document describes a physical medical device, not an AI system.

Summary

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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2023

Suzhou Endophix Co., Ltd. Jaun Wu RA Specialist NO. 151, Fengli Road Suzhou, Jiangsu 215000 China

Re: K231002

Trade/Device Name: Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: April 7, 2023 Received: April 7, 2023

Dear Jaun Wu:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jesse Muir -S

Jesse Muir, PhD 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

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Indications for Use

510(k) Number (if known) K231002

Device Name Javelot PK-S suture anchor

Indications for Use (Describe)
The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder:
-Bankart lesion repair
-SLAP lesion repair
-Acromioclavicular separation repair
-Rotator cuff tear repair
-Capsular shift or capsulolabral reconstruction
-Biceps tenodesis
-Deltoid repair
Foot/Ankle:
-Hallux Valgus repair
-Medial or lateral instability repair/reconstruction
-Achilles tendon repair/reconstruction
-Midfoot reconstruction
-Metatarsal ligament/tendon repair/reconstruction
Elbow:
-Ulnar or radial collateral ligament reconstruction
-Lateral epicondylitis repair
-Biceps tendon reattachment
Knee:
-Extra-capsular repair
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
-Iliotibial band tenodesis
-Patellar realignment and tendon repair
Vastus medialis obliquus advancement
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231002

Device Name Javelot PK-S suture anchor (Knotless)

Indications for Use (Describe)

The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications: Shoulder:

-Bankart repair

• -SLAP lesion repair
• -Acromioclavicular separation repair
• -Rotator cuff repair
• -Capsular shift or capsulolabral reconstruction
• -Biceps tenodesis
• -Deltoid repair

Foot/Ankle:

• -Hallux Valgus reconstruction
• -Medial stabilization
• -Lateral stabilization
• -Achilles tendon repair
• -Mid-foot reconstruction
• -Metatarsal ligament/ tendon repair
• -Bunionectorny

Elbow:

• -Ulnar/ radial collateral ligament reconstruction -Biceps tendon reattachment
• -Lateral epicondylitis repair

Hand/Wrist:

• -Scapholunate ligament reconstruction
• -Ulnar/Radial collateral ligament reconstruction

Knee:

• -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair -Iliotibial band tenodesis -Patellar tendon repairs -Anterior cruciate ligament repair (4.75-5.5mm anchors only) -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only) -Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only) Hip:
  -Capsular Repair -Acetabular labral repair FORM FDA 3881 (6/20)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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• -Proximal hamstring repair (4.75-5.5mm anchors only)
• -Gluteus Medius Repair (4.75-5.5mm anchors only)

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)
----------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K231002

Device Name Javelot PK-P suture anchor

Indications for Use (Describe)

The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder:

• -Rotator cuff repair
  -Bankart repair

-SLAP lesion repair

-Biceps tenodesis

-Acromioclavicular separation repair

-Deltoid repair

-Capsular shift or capsulolabral reconstruction

Foot/Ankle:

• -Lateral stabilization
  -Medial stabilization

-Achilles tendon repair

-Metatarsal ligament repair

-Hallux valgus reconstruction

-Digital tendon transfers

-Mid-foot reconstruction

Knee:

-Medial collateral ligament repair -Lateral collateral ligament repair -Patellar tendon repair -Posterior oblique ligament repair

-Iliotibial band tenodesis

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

Elbow:

-Biceps tendon reattachment

-Ulnar or radial collateral ligament reconstruction

Hip:
-Capsular repair
-Acetabular labral repair

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)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------

FORM FDA 3881 (6/20)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

PSC Publishing Services [phone]

EF

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CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{8}------------------------------------------------

Indications for Use

510(k) Number (if known) K231002

Device Name Javelot PK-P suture anchor (Knotless)

Indications for Use (Describe)

The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

• Shoulder:
  -Bankart repair

• -SLAP lesion repair

• -Acromioclavicular separation repair

• -Rotator cuff repair

• -Capsular shift or capsulolabral reconstruction

• -Biceps tenodesis

• -Deltoid repair

• Foot/ Ankle: -Hallux Valgus reconstruction -Medial stabilization -Lateral stabilization -Achilles Tendon Repair -Mid-foot reconstruction -Metatarsal ligament repair/ tendon repair -Digital tendon transfers (2.5mm anchor only) -Bunionectomy (2.9-4.5mm anchors only)

Elbow:

-Ulnar or radial collateral ligament reconstructions

-Biceps tendon reattachment

• -Lateral epicondylitis repair (2.9-4.5mm anchors only)
  Hand/ Wrist:

-Scapholunate ligament reconstruction

-Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only)

-Radial collateral ligament reconstruction (2.9-4.5mm anchors only)

-Carpal ligament reconstruction (2.5mm anchors only)

-Repair/Reconstruction of collateral ligaments (2.5mm anchors only)

-Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only)

-Digital tendon transfers (2.5mm anchors only)

Knee:

-Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repairs

Hip: (2.9-4.5mm anchors only)

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-Acetabular labral repair -Capsular 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{10}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231002

Device Name Javelot PK-L suture anchor (Knotless)

Indications for Use (Describe)

The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

• Shoulder:
• -Bankart lesion repair
• -SLAP lesion repair
• -Acromioclavicular separation repair
• -Rotator cuff tear repair
• -Capsular shift or capsulolabral reconstruction
• -Biceps tenodesis
• -Deltoid repair
• -Anterior shoulder instability (3.7mm anchors only)

Foot/ Ankle:

• -Hallux Valgus repair
• -Medial or lateral instability repair
• -Midfoot reconstruction
• -Metatarsal ligament/tendon repair/reconstruction
• -Achilles tendon repair/reconstruction
• -Bunionectomy (3.7mm anchors only)

Elbow:

• -Ulnar or radial collateral ligament reconstruction -Biceps tendon reattachment -Lateral epicondylitis repair (3.7mm anchors only)
• Hand/Wrist:
• -Scapholunate ligament reconstruction
• -Ulnar collateral ligament reconstruction
• -Radial collateral ligament reconstruction

Knee:

• -Medial collateral ligament repair -Lateral collateral ligament repair -Posterior oblique ligament repair
• -Iliotibial band tenodesis
• -Patellar tendon repair

Hip: (3.7mm anchors only) -Hip capsule repair Acetabular labrum reattachment/ reconstruction

PSC Publishing Services [phone]

EF

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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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{12}------------------------------------------------

510(k) Summary

l Submitter

Device submitter:	Suzhou Endophix Co., Ltd.NO.151, Fengli Road, SIP, 215000 Suzhou, JiangsuProvince, PEOPLE'S REPUBLIC OF CHINA
Primary contact person:	Juan WuRegulatory Affairs SpecialistPhone: [phone]Email: [e-mail]

Date of preparation: 2023-04-07

II Device

Trade Name of Device:	Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Common Name:	suture anchor
Classification Name:	Fastener, Fixation, Non-degradable, Soft Tissue
Regulatory Class:	II
Product Code:	MBI
Review Panel:	Orthopedic
Regulation Number:	888.3040

III Predicate Devices

Trade Name:	TWINFIX TM Ultra PK Suture Anchor
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040
Product Code:	MBI
Premarket Notification:	K093228
Manufacturer:	Smith & Nephew, Inc., Endoscopy Division
Trade Name:	Arthrex Swivelock Anchors
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	MAI, HWC
Premarket Notification:	K101823
Manufacturer:	Arthrex, Inc.
Trade Name:	Arthrex SwiveLock Suture Anchor
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	MAI, MBI
Premarket Notification:	K203495
Manufacturer:	Arthrex, Inc.
Trade Name:	Arthrex SutureTak Suture Anchors
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	MAI, MBI
Premarket Notification:	K140855
Manufacturer:	Arthrex, Inc.
Trade Name:	Arthrex PushLock™
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	HWC, JDR, MAI, MBI
Premarket Notification:	K061863
Manufacturer:	Arthrex, Inc.
Trade Name:	Arthrex 2.5mm PushLock™
Common Name:	Fastener; Screw, Fixation, Bone
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	HWC, MAI, MBI
Premarket Notification:	K063479
Manufacturer:	Arthrex, Inc.
Trade Name:	FOOTPRINT Ultra PK Suture Anchor
Common Name:	suture anchor
Classification:	Class II, 21 CFR 888.3040
Product Code:	MBI
Premarket Notification:	K093897
Manufacturer:	Smith & Nephew, Inc., Endoscopy Division
Trade Name:	BIORAPTOR™ Knotless Suture Anchor
Common Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Classification:	Class II, 21 CFR 888.3040, 21 CFR 888.3030
Product Code:	MAI, MBI

{13}------------------------------------------------

K231002

{14}------------------------------------------------

Premarket Notification: K121018 Smith & Nephew, Inc. Manufacturer:

IV Device description

All Javelot PEEK suture anchors are preassembled onto an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a polyetheretherketone (PEEK) material with a screw-in, push-in (with or without lock-in) design. The sutures are offered in non-absorbable USP braid ultrahigh molecular weight polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rod is offered in stainless steel material, the insertion handle is offered in acrylonitrile butadiene Styrene copolymers (ABS) material. Javelot PEEK suture anchors come in various configurations, including: with attached nonabsorbable suture(s). Javelot PEEK suture anchors are non-absorbable, provided sterile, for single use only.

V Indications for use

Javelot PEEK suture anchors - Javelot PK-S suture anchor

The Javelot PK-S suture anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart lesion repair

• -SLAP lesion repair
  -Acromioclavicular separation repair

-Rotator cuff tear repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

Foot/Ankle:

-Hallux Valgus repair

-Medial or lateral instability repair/reconstruction

-Achilles tendon repair/reconstruction

-Midfoot reconstruction

-Metatarsal ligament/tendon repair/reconstruction

Elbow:

-Ulnar or radial collateral ligament reconstruction

-Lateral epicondylitis repair

-Biceps tendon reattachment

Knee:

-Extra-capsular repair

• Medial collateral ligament

{15}------------------------------------------------

• Lateral collateral ligament
• Posterior oblique ligament
• -Iliotibial band tenodesis

-Patellar realignment and tendon repair

• Vastus medialis obliquus advancement

Javelot PEEK suture anchors - Javelot PK-S suture anchor (Knotless)

The Javelot PK-S suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart repair

• -SLAP lesion repair
• -Acromioclavicular separation repair
• -Rotator cuff repair
• -Capsular shift or capsulolabral reconstruction
• -Biceps tenodesis
• -Deltoid repair

Foot/Ankle:

• -Hallux Valgus reconstruction
• -Medial stabilization
• -Lateral stabilization
• -Achilles tendon repair
• -Mid-foot reconstruction
• -Metatarsal ligament/ tendon repair
• -Bunionectorny

Elbow:

-Ulnar/ radial collateral ligament reconstruction

• -Biceps tendon reattachment
• -Lateral epicondylitis repair

Hand/Wrist:

• -Scapholunate ligament reconstruction
• -Ulnar/Radial collateral ligament reconstruction

Knee:

• -Medial collateral ligament repair
• -Lateral collateral ligament repair
• -Posterior oblique ligament repair
• -Iliotibial band tenodesis
• -Patellar tendon repairs
• -Anterior cruciate ligament repair (4.75-5.5mm anchors only)
• -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5mm anchors only)

{16}------------------------------------------------

-Quadriceps tendon repair (4.75 mm anchors only) -Meniscal root repair (4.75 mm anchors only)

Hip:

-Capsular Repair -Acetabular labral repair -Proximal hamstring repair (4.75-5.5mm anchors only) -Gluteus Medius Repair (4.75-5.5mm anchors only)

Javelot PEEK suture anchors - Javelot PK-P suture anchor

The Javelot PK-P suture anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Rotator cuff repair

• -Bankart repair
• -SLAP lesion repair
• -Biceps tenodesis
• -Acromioclavicular separation repair
• -Deltoid repair

-Capsular shift or capsulolabral reconstruction

Foot/Ankle:

-Lateral stabilization

• -Medial stabilization
• -Achilles tendon repair
• -Metatarsal ligament repair
• -Hallux valgus reconstruction
• -Digital tendon transfers
• -Mid-foot reconstruction

Knee:

• -Medial collateral ligament repair
• -Lateral collateral ligament repair
• -Patellar tendon repair
• -Posterior oblique ligament repair
• -Iliotibial band tenodesis

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

Elbow:

-Biceps tendon reattachment

{17}------------------------------------------------

-Ulnar or radial collateral ligament reconstruction

Hip:

-Capsular repair

-Acetabular labral repair

Javelot PEEK suture anchors - Javelot PK-P suture anchor (Knotless)

The Javelot PK-P suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart repair

-SLAP lesion repair

• -Acromioclavicular separation repair
  -Rotator cuff repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

Foot/ Ankle:

-Hallux Valgus reconstruction

-Medial stabilization

-Lateral stabilization

-Achilles Tendon Repair

-Mid-foot reconstruction

-Metatarsal ligament repair/ tendon repair

-Digital tendon transfers (2.5mm anchor only)

-Bunionectomy (2.9-4.5mm anchors only)

Elbow:

-Ulnar or radial collateral ligament reconstructions

-Biceps tendon reattachment

-Lateral epicondylitis repair (2.9-4.5mm anchors only)

Hand/ Wrist:

-Scapholunate ligament reconstruction

-Ulnar collateral ligament reconstruction (2.9-4.5mm anchors only)

-Radial collateral ligament reconstruction (2.9-4.5mm anchors only)

-Carpal ligament reconstruction (2.5mm anchors only)

-Repair/Reconstruction of collateral ligaments (2.5mm anchors only)

-Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits (2.5mm anchors only)

-Digital tendon transfers (2.5mm anchors only)

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

{18}------------------------------------------------

-Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repairs

Hip: (2.9-4.5mm anchors only)

-Acetabular labral repair

-Capsular repair

Javelot PEEK suture anchors - Javelot PK-L suture anchor (Knotless)

The Javelot PK-L suture anchor (Knotless) is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:

-Bankart lesion repair

-SLAP lesion repair

-Acromioclavicular separation repair

-Rotator cuff tear repair

-Capsular shift or capsulolabral reconstruction

-Biceps tenodesis

-Deltoid repair

-Anterior shoulder instability (3.7mm anchors only)

Foot/ Ankle:

-Hallux Valgus repair

-Medial or lateral instability repair

-Midfoot reconstruction

-Metatarsal ligament/tendon repair/reconstruction

-Achilles tendon repair/reconstruction

-Bunionectomy (3.7mm anchors only)

Elbow:

-Ulnar or radial collateral ligament reconstruction

-Biceps tendon reattachment

-Lateral epicondylitis repair (3.7mm anchors only)

Hand/Wrist:

-Scapholunate ligament reconstruction

-Ulnar collateral ligament reconstruction

-Radial collateral ligament reconstruction

Knee:

-Medial collateral ligament repair

-Lateral collateral ligament repair

-Posterior oblique ligament repair

-Iliotibial band tenodesis

-Patellar tendon repair

Hip: (3.7mm anchors only)

{19}------------------------------------------------

-Hip capsule repair

• Acetabular labrum reattachment/ reconstruction

VI Comparison of technological characteristics with the predicate devices

Javelot PEEK suture anchors have similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate device do not alter suitability of the proposed device for its intended use.

Characteristics	Subject Device (JavelotPK-S suture anchor)	Predicate DeviceK093228, TWINFIXTMUltra PK Suture Anchor	Remarks
Product Code	MBI	MBI	Identical aspredicatedevice.
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Identical aspredicatedevice.
RegulatoryClass	Class II	Class II	Identical aspredicatedevice.
Intended Use	The Javelot PK-S sutureanchor is intended for thereattachment of softtissue to bone for thefollowing indications:Shoulder:-Bankart lesion repair-SLAP lesion repair-Acromioclavicularseparation repair-Rotator cuff tear repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/Ankle:-Hallux Valgus repair-Medial or lateral	The Smith & NephewTWINFIX Ultra PK SutureAnchor is intended for usefor the reattachment ofsoft tissue to bone for thefollowing indications:Shoulder:-Bankart lesion repairs-SLAP lesion repairs-Acromioclavicularseparation repairs-Rotator cuff tear repairs-Capsular shift orcapsulolabralreconstructions-Biceps tenodesis-Deltoid repairsFoot/Ankle:-Hallux Valgus repairs	Identical aspredicatedevice.
	instability	-Medial or lateralinstability
	repair/reconstruction	repairs/reconstructions
	-Achilles tendonrepair/reconstruction	-Achilles tendonrepairs/reconstruction
	-Midfoot reconstruction	-Midfoot reconstructions
	-Metatarsalligament/tendonrepair/reconstruction	-Metatarsalligament/tendonrepairs/reconstructions
	Elbow:	Elbow:
	-Ulnar or radial collateralligament reconstruction	-Ulnar or radial collateralligament reconstructions
	-Lateral epicondylitisrepair	-Lateral epicondylitisrepair
	-Biceps tendonreattachment	-Biceps tendonreattachment
	Knee:	Knee:
	-Extra-capsular repair	-Extra-capsular repairs
	• Medial collateralligament	• Medial collateralligament
	• Lateral collateralligament	• Lateral collateralligament
	• Posterior obliqueligament	• Posterior obliqueligament
	-Iliotibial band tenodesis	-Iliotibial band tenodesis
	-Patellar realignment andtendon repair	-Patellar realignment andtendon repairs
	• Vastus medialisobliquus advancement	• Vastus medialisobliquus advancement
Composition	Implantable part: Anchor,suture	Implantable part: Anchor,suture	Identical aspredicate device.
	Non-implantable part:inserter	Non-implantable part:inserter
Key PatientContactingMaterial	Anchor: PEEKSuture: UHMWPE	Anchor: PEEKSuture: UHMWPE	Identical aspredicate device.
DimensionalVerification	Anchor diameter:4.5mm, 5.5mm, 6.5mmAnchor length: 19mm	Anchor diameter:4.5mm, 5.5mm, 6.5mmAnchor length: 19mm	Substantiallyequivalent.
Anchor type	Screw-in suture anchor	Screw-in suture anchor	Identical aspredicate device.
Sterilization	EO sterilization	EO sterilization	Identical aspredicatedevice.
Shelf-life	5 Years	5 Years	Identical aspredicatedevice.
SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice.
OperatingPrinciple	Implant the anchor intothe bone to form ananchorage with the bone.The suture connected tothe anchor can re-sutureand fix the soft tissuessuch as tendons andligaments, so that theycan be re-fixed on thesurface of bone.	Implant the anchor intothe bone to form ananchorage with the bone.The suture connected tothe anchor can re-sutureand fix the soft tissuessuch as tendons andligaments, so that theycan be re-fixed on thesurface of bone.	Identical aspredicatedevice.
Environment ofUse	Hospitals/clinics	Hospitals/clinics	Identical aspredicatedevice.

Table 5.1 Substantial equivalence discussion - Javelot PK-S suture anchor

{20}------------------------------------------------

K231002

{21}------------------------------------------------

Table 5.2 Substantial equivalence discussion - Javelot PK-S suture anchor (Knotless)

Characteristics	Subject(Javelot PK-S sutureanchor (Knotless))	Device	Predicate Device	Remarks
			K101823, SwiveLocksuture anchor(Primary Predicate)
			K203495, SwiveLocksuture anchor(Secondary Predicate)
Product Code	MBI		K101823: MAI, HIWCK203495: MAI, MBI	Different aspredicatedeviceincludesabsorbabledevices
			whose code
			is different.
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Identical aspredicatedevice.
RegulatoryClass	Class II	Class II	Identical aspredicatedevice.
Indications foruse	The Javelot PK-S sutureanchor (Knotless) isintended for thereattachment of softtissue to bone for thefollowing indications:Shoulder:-Bankart repair-SLAP lesion repair-Acromioclavicularseparation repair-Rotator cuff repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/Ankle:-Hallux Valgusreconstruction-Medial stabilization-Lateral stabilization-Achilles tendon repair-Mid-foot reconstruction-Metatarsal ligament/tendon repair-BunionectornyElbow:-Ulnar/ radial collateralligament reconstruction-Biceps tendonreattachment-Lateral epicondylitis	(K101823) The ArthrexSwiveLock Anchors areintended for fixation ofsuture (soft tissue) tobone in the shoulder,foot/ankle, knee,hand/wrist, elbow, andhip in the followingprocedures:Shoulder:-Bankart repair-SLAP lesion repair-Acromio-clavicularseparation repair-Rotator cuff repairs-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/Ankle:-Hallux Valgusreconstruction-Medial stabilization-Lateral stabilization-Achilles tendon repair-Mid-foot reconstruction-Metatarsal ligamentrepair/ tendon repair-Bunionectorny.Elbow:-Ulnar or radial collateralligament reconstruction	Substantiallyequivalent.

{22}------------------------------------------------

{23}------------------------------------------------

K231002

repair	-Biceps tendon
Hand/Wrist:	reattachment
-Scapholunate ligamentreconstruction	-Tennis elbow repair
-Ulnar/Radial collateralligament reconstruction	-Lateral epicondylitisrepair
Knee:	Hand/Wrist:
-Medial collateralligament repair	-Scapholunate ligamentreconstruction
-Lateral collateralligament repair	-Ulnar or Radial collateralligament reconstruction
-Posterior obliqueligament repair	-Radial collateralligament reconstruction
-Iliotibial band tenodesis	Knee:
-Patellar tendon repairs	-Medial collateralligament repair
-Anterior cruciateligament repair (4.75-5.5mm anchors only)	-Lateral collateralligament repair
-Secondary or adjunctfixation for ACL/PCLreconstruction or repair(4.75-5.5mm anchorsonly)	-Posterior obliqueligament repair
-Quadriceps tendonrepair (4.75 mm anchorsonly)	-Iliotibial band tenodesis
-Meniscal root repair(4.75 mm anchors only)	-Patellar tendon repairs
Hip:	Hip:
-Capsular Repair	-Capsular Repair
-Acetabular labral repair	-Acetabular labral repair
-Proximal hamstringrepair(4.75-5.5mmanchors only)	(K203495) The ArthrexSwiveLock Anchor isintended for fixation ofsuture (soft tissue) tobone in the shoulder,foot/ankle, knee,hand/wrist, elbow, andhip in skeletally maturepediatric and adultpatients for the followingprocedures:
-Gluteus Medius Repair(4.75-5.5mm anchorsonly)	Shoulder:
	-Bankart repair
	-SLAP lesion repair
	-Acromio-clavicularseparation repair
-Rotator cuff repair
-Capsular shift orcapsulolabralreconstruction
-Biceps tenodesiscapsulolabralreconstruction
-Deltoid repair
Foot/ Ankle:
-Hallux Valgus repair
-Medial stabilization
-Lateral stabilization
-Achilles tendonreconstruction,
-Mid-foot reconstruction
-Metatarsal ligament/tendon repair
-Bunionectorny.
Elbow:
-Ulnar/ radial collateralligament reconstruction
-Biceps tendonreattachment
-Lateral epicondylitisrepair
Hand/Wrist:
-Scapholunate ligamentreconstruction
-Ulnar/Radial collateralligament reconstruction
Knee:
-Medial collateralligament repair
-Lateral collateralligament repair
-Posterior obliqueligament repair
-Iliotibial band tenodesis
-Patellar tendon repairs
-Anterior cruciateligament repair(4.75-5.5

{24}------------------------------------------------

{25}------------------------------------------------

		SwiveLock Only) -Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock Only) -Quadriceps tendon repair (4.75 SwiveLock C Only) -Meniscal root repair (4.75 SwiveLock C Only) -MPFL repair/ reconstruction (3.9 SwiveLock Only) Hip: -Capsular Repair -Acetabular labral repair -Proximal hamstring repair(4.75-5.5mm PEEK SwiveLock suture anchors only)) -Gluteus Medius Repair(4.75-5.5mm PEEK SwiveLock suture anchors only))
Composition	Implantable part: Anchor, suture Non-implantable part: inserter	Implantable part: Anchor, suture Non-implantable part: inserter	Identical as predicate device.
Key Patient Contacting Material	Anchor: PEEK Suture: UHMWPE	Anchor: PEEK Suture: UHMWPE	Identical as predicate device.
Dimensional Verification	Anchor diameter: 3.5mm, 4.75mm, 5.5mm	Anchor diameter: 3.5mm, 3.9mm, 4.75mm, 5.5mm	Substantially equivalent.
Anchor type	Screw-in knotless suture anchor Two-component anchor comprised of an eyelet and a hollow anchor body	Screw-in knotless suture anchor Two-component anchor comprised of an eyelet and a hollow anchor body	Substantially equivalent.
Sterilization	EO sterilization	EO sterilization	Identical as
			predicatedevice.
Shelf-life	5 Years	5 Years	Identical aspredicatedevice.
SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice.
OperatingPrinciple	Implant the anchor intothe bone to form ananchorage with the bone.The sutureconnected to the anchorcan re-suture and fix thesoft tissues such astendons and ligaments,so that they can be re-fixed on the surface ofbone.	Implant the anchor intothe bone to form ananchorage with the bone.The suture connected tothe anchor can re-sutureand fix the soft tissuessuch as tendons andligaments, so that theycan be re-fixed on thesurface of bone.	Identical aspredicatedevice.
Environment ofUse	Hospitals/clinics	Hospitals/clinics	Identical aspredicatedevice.

{26}------------------------------------------------

Table 5.3 Substantial equivalence discussion - Javelot PK-P suture anchor

Characteristics	Subject(Javelot PK-P sutureanchor)		Predicate Device	Remarks
Product Code	MBI		K140855, SutureTakSuture AnchorMBI, MAI	Different as predicate device includes absorbable devices whose code is MAI.
Regulation Number	21 CFR 888.3040		21 CFR 888.304021 CFR 888.3030	Different as predicate device includes absorbable

{27}------------------------------------------------

K231002

RegulatoryClass	Indications foruse	Class II	Class II	devices
				Identical aspredicatedevice.
		The Javelot PK-P sutureanchor is intended forthe reattachment of softtissue to bone for thefollowing indications:Shoulder:-Rotator cuff repair-Bankart repair-SLAP lesion repair-Biceps tenodesis-Acromioclavicularseparation repair-Deltoid repair-Capsular shift orcapsulolabralreconstructionFoot/Ankle:-Lateral stabilization-Medial stabilization-Achilles tendon repair-Metatarsal ligamentrepair-Hallux valgusreconstruction-Digital tendon transfers-Mid-foot reconstructionKnee:-Medial collateralligament repair-Lateral collateralligament repair-Patellar tendon repair-Posterior obliqueligament repair-Iliotibial band tenodesisHand/Wrist:-Scapholunate ligament	The Arthrex SutureTaksuture anchors areintended to be used forsuture (soft tissue)fixation to bone in thefoot, ankle, knee, hand,wrist, elbow, shoulder,and hip.Shoulder:-Rotator cuff repair-Bankart repair-SLAP lesion repair-Biceps tenodesis-Acromio-clavicularseparation repair-Deltoid repair-Capsular shift orcapsulolabralreconstructionFoot/Ankle:-Lateral stabilization-Medial stabilization-Achilles tendon repair-Metatarsal ligamentrepair-Hallux valgusreconstruction-Digital tendon transfers-Mid-foot reconstructionKnee:-Medial collateralligament repair-Lateral collateralligament repair-Patellar tendon repair-Posterior obliqueligament repair	Identical aspredicatedevice.
	reconstruction	-Iliotibial band tenodesis
	-Carpal ligamentreconstruction	Hand/Wrist:-Scapholunate ligamentreconstruction
	-Repair/Reconstructionof collateral ligaments	-Carpal ligamentreconstruction
	-Repair of flexor andextensor tendons at thePIP, DIP, and MCP jointsfor all digits	-Repair/Reconstructionof collateral ligaments
	-Digital tendon transfersElbow:-Biceps tendonreattachment	-Repair of flexor andextensor tendons at thePIP, DIP, and MCP jointsfor all digits
	-Ulnar or radial collateralligament reconstructionHip:-Capsular repair-Acetabular labral repair	-Digital tendon transfersElbow:-Biceps tendonreattachment
		-Ulnar or radial collateralligament reconstructionHip:-Capsular repair-Acetabular labral repair
Composition	Implantable part:Anchor, sutureNon-implantable part:inserter	Implantable part: Anchor, sutureNon-implantable part:inserter	Identical aspredicatedevice.
Key PatientContactingMaterial	Anchor: PEEKSuture: UHMWPE	Anchor: PEEKSuture: UHMWPE	Identical aspredicatedevice.
DimensionalVerification	Anchor diameter:2.0mm, 2.4mm, 3.0mm	Anchor diameter: 2.0mm,2.4mm, 3.0mm	Substantiallyequivalent.
Anchor type	Push-in suture anchor	Push-in suture anchor	Identical aspredicatedevice.
Sterilization	EO sterilization	EO sterilization	Identical aspredicatedevice.
Shelf-life	5 Years	5 Years	Identical aspredicatedevice.
SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice.
			device.
OperatingPrinciple	Implant the anchor intothe bone to form ananchorage with thebone. The sutureconnected to the anchorcan re-suture and fix thesoft tissues such astendons and ligaments,so that they can be re-fixed on the surface ofbone.	Implant the anchor intothe bone to form ananchorage with the bone.The suture connected tothe anchor can re-sutureand fix the soft tissuessuch as tendons andligaments, so that theycan be re-fixed on thesurface of bone.	Identical aspredicatedevice.
Environment ofUse	Hospitals/clinics	Hospitals/clinics	Identical aspredicatedevice.

{28}------------------------------------------------

{29}------------------------------------------------

Table 5.4 Substantial equivalence discussion - Javelot PK-P suture anchor (Knotless)

Characteristics	Subject(Javelot PK-P sutureanchor (Knotless))	Device	Predicate Device	Remarks
Product Code	MBI		K061863: HWC, MBI,JDR, MAIK063479: HWC, MAI,MBI	Different as predicatedevice includesabsorbable deviceswhose code is different.
RegulationNumber	21 CFR 888.3040		21 CFR 888.3040	Identical aspredicate device.
RegulatoryClass	Class II		Class II	Identical aspredicate device.
Indicationsfor	The Javelot PK-P suture		(K061863)	Substantially
use	anchor (Knotless) isintended for thereattachment of softtissue to bone for thefollowing indications:Shoulder:-Bankart repair-SLAP lesion repair-Acromioclavicularseparation repair-Rotator cuff repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/ Ankle:-Hallux Valgusreconstruction-Medial stabilization-Lateral stabilization-Achilles Tendon Repair-Mid-foot reconstruction-Metatarsal ligamentrepair/ tendon repair-Digital tendon transfers(2.5mm anchor only)-Bunionectomy (2.9-4.5mm anchors only)Elbow:-Ulnar or radial collateralligament reconstructions-Biceps tendonreattachment-Lateral epicondylitisrepair (2.9-4.5mmanchors only)Hand/ Wrist:-Scapholunate ligamentreconstruction-Ulnar collateral	The Arthrex PushLock™,previously cleared under510(k) K051219, isintended for fixation ofsuture (soft tissue) tobone in the shoulder,foot/ankle, knee,hand/wrist, elbow, hip,and pelvis in the followingprocedures:Shoulder:-Bankart repair-SLAP lesion repair-Acromio-clavicularseparation repair-Rotator cuff repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/ Ankle:-Hallux Valgusreconstruction-Medial stabilization-Lateral stabilization-Achilles Tendon Repair-Mid-foot reconstruction-Metatarsal ligamentrepair/ tendon repair-BunionectomyElbow:-Ulnar or radial collateralligament reconstruction-Biceps tendonreattachment-Tennis elbow repair-Lateral epicondylitisrepairHand/ Wrist:-Scapholunate ligament	equivalent.

{30}------------------------------------------------

{31}------------------------------------------------

K231002

ligament reconstruction(2.9-4.5mm anchorsonly)	reconstruction
-Radial collateralligament reconstruction(2.9-4.5mm anchorsonly)	-Ulnar collateral ligamentreconstruction			reconstruction
-Carpal ligamentreconstruction (2.5mmanchors only)	-Radial collateralligament reconstruction			-Carpal LigamentReconstruction
-Repair/Reconstructionof collateral ligaments(2.5mm anchors only)	Knee:			-Repair/Reconstructionof collateral ligaments
-Repair of Flexor andExtensor Tendons at thePIP, DIP and MCP jointsfor all digits (2.5mmanchors only)	-Medial collateralligament repair			-Repair of Flexor andExtensor Tendons at thePIP, DIP and MCP jointsfor all digits
-Digital tendon transfers(2.5mm anchors only)	-Lateral collateralligament repair			-Digital tendon transfers
Knee:	-Posterior obliqueligament repair			Knee:
-Medial collateralligament repair	-Iliotibial band tenodesis			-Medial collateralligament repair
-Lateral collateralligament repair	-Patellar tendon repairs			-Lateral collateralligament repair
-Posterior obliqueligament repair	Hip:			-Posterior obliqueligament repair
-Iliotibial band tenodesis	-Capsular repair			-Iliotibial band tenodesis
-Patellar tendon repairs	-Acetabular labral repair			-Patellar tendon repair
Hip:(2.9-4.5mmanchors only)	Pelvis:	Composition	Implantable part: AnchorNon-implantable part:inserter	Implantable part: AnchorNon-implantable part:inserter	Identical aspredicatedevice.
-Acetabular labral repair	Bladder NeckSuspension for femaleurinary incontinence dueto urethral hypermobilityor intrinsic sphincterdeficiency	Key PatientContactingMaterial	Anchor: PEEK	Anchor: PEEK	Identical aspredicatedevice.
-Capsular repair	(K063479) The ArthrexPushLock™ is intendedto be used for suture ortissue fixation in the foot,ankle, knee, hand, wrist,elbow, shoulder, and inselect maxillofacialapplications. Specificindications are listedbelow:	DimensionalVerification	Anchor diameter:2.5mm, 2.9mm, 3.5mm,4.5mm	K061863, Anchordiameter:2.9mm,3.5mm, 4.5mmK063479, Anchordiameter: 2.5mm	Substantiallyequivalent.
	Skull:	Anchor type	Push-in knotless sutureanchorTwo-component anchorcomprised of an eyeletand a hollow anchorbody	Push-in knotless sutureanchorTwo-component anchorcomprised of an eyeletand a hollow anchor body	Identical aspredicatedevice.
	-Stabilization and fixationof oral cranio-maxillofacial skeletalbone	Sterilization	EO sterilization	Irradiation sterilization	Different, butthesterilization isvalidated andsubject
	-Mandible and
maxillofacial bones-Lateral Canthoplasty-Repair of NasalVestibular Stenosis-Brow Lift-Temporomandibular Joint (TMJ) reconstruction-Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skullShoulder:-Bankart repair-SLAP lesion repair-Acromio-clavicular separation repair-Rotator cuff repair-Capsular shift or capsulolabral reconstruction-Biceps tenodesis-Deltoid repairFoot/ Ankle:-Hallux Valgus reconstruction-Medial stabilization-Lateral stabilization-Achilles Tendon Repair-Mid-foot reconstruction-Metatarsal ligament repair-Digital tendon transfersElbow:-Ulnar or radial collateral ligament reconstruction-Biceps tendon reattachmentHand/ Wrist:-Scanbolunate ligament

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			device has aSAL of $10^{-6}$ .
Shelf-life	5 Years	5 Years	Identical aspredicatedevice.
SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice.
OperatingPrinciple	Implant the anchor intothe bone to form ananchorage with thebone. Connectappropriate suture to theanchor to re-suture andfix the soft tissues suchas tendons andligaments, so that thesoft tissues can be re-fixed on the surface ofbone.	Implant the anchor intothe bone to form ananchorage with the bone.Connect appropriatesuture to the anchor to re-suture and fix the softtissues such as tendonsand ligaments, so that thesoft tissues can be re-fixed on the surface ofbone.	Identical aspredicatedevice.
Environment ofUse	Hospitals/clinics	Hospitals/clinics	Identical aspredicatedevice.

Table 5.5 Substantial equivalence discussion - Javelot PK-L suture anchor (Knotless)

Characteristics	Subject(Javelot PK-L sutureanchor (Knotless))	Predicate Device	Remarks
		K093897, FOOTPRINTUltra Suture Anchor(Primary Predicate)
		K121018, BIORAPTORKnotless Suture Anchor(Secondary Predicate)
Product Code	MBI	MBI (K093897)MAI, MBI (K121018)	Different asK121018includesotherdeviceswhose codeis MAI.

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K231002

RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Identical aspredicatedevice.
RegulatoryClass	Class II	Class II	Identical aspredicatedevice.
Indications foruse	The Javelot PK-L sutureanchor (Knotless) isintended for thereattachment of softtissue to bone for thefollowing indications:Shoulder:-Bankart lesion repair-SLAP lesion repair-Acromioclavicularseparation repair-Rotator cuff tear repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repair-Anterior shoulderinstability (3.7mmanchors only)Foot/ Ankle:-Hallux Valgus repair-Medial or lateralinstability repair-Midfoot reconstruction-Metatarsalligament/tendonrepair/reconstruction-Achilles tendonrepair/reconstruction-Bunionectomy (3.7mmanchors only)Elbow:-Ulnar or radial collateralligament reconstruction	The Smith & NephewFOOTPRINT Ultra PKSutureAnchor(K093897) is intended foruse for the reattachmentof soft tissue to bone forthe following indications:Shoulder:-Bankart repair-SLAP lesion repair-Acromio-clavicularseparation-Rotator cuff repair-Capsular shift orcapsulolabralreconstruction-Biceps tenodesis-Deltoid repairFoot/Ankle:-Hallux Valgus repairs-Medial stabilization-Lateral stabilization-Achilles tendon repair-Mid-foot reconstructions-Metatarsal ligamentrepairElbow:-Ulnar or radial collateralligament reconstruction-Biceps tendonreattachmentHand/Wrist:-Scapholunate ligamentreconstruction-Ulnar collateral ligament	Substantiallyequivalent.

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-Biceps tendon reattachment	reconstruction
-Lateral epicondylitis ligament repair (3.7mm anchors only)	-Radial collateral ligament reconstruction
Hand/Wrist:	Knee:
-Scapholunate ligament reconstruction	-Medial collateral ligament repair
-Ulnar collateral ligament reconstruction	-Lateral collateral ligament repair
-Radial collateral ligament reconstruction	-Posterior oblique ligament repair
Knee:	- Iliotibial band tenodesis
-Medial collateral ligament repair	-Patellar tendon repair
-Lateral collateral ligament repair	The Smith & Nephew Suture Anchors (K121018) are intended for the reattachment of soft tissue to bone for the following indications:
-Posterior oblique ligament repair	Shoulder:
-Iliotibial band tenodesis	-Capsular stabilization
-Patellar tendon repair	• Bankart repair
Hip: (3.7mm anchors only)	• SLAP lesion repairs
-Hip capsule repair	• Anterior shoulder instability
• Acetabular labrum reattachment/ reconstruction	• Capsular shift or capsulolabral reconstructions
	-Acromioclavicular separation repairs
	-Rotator Cuff repairs
	-Biceps tenodesis
	-Deltoid repairs
	Foot/Ankle:
	-Hallux valgus repairs
	-Medial or lateral instability repairs/ reconstructions
	-Achilles tendon repairs/reconstructions
	Midfoot reconstructions

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		-Metatarsalligament/tendonrepairs/reconstructions-BunionectomyElbow, Wrist, andHand:-Ulnar or radial collateralligament reconstructions-Lateral epicondylitisrepair-Biceps tendonreattachmentKnee:-Extra-capsular repairs• Medial collateralligament• Lateral collateralligament• Posterior obliqueligament-Iliotibial band tenodesis-Patellar realignment andtendon repairs• Vastus medialisobliquousadvancementHip:-Hip capsule repair• Acetabular labrumreattachment/reconstruction
Composition	Implantable part: AnchorNon-implantable part:suture, inserter	Implantable part: AnchorNon-implantable part:suture, inserter	Identical aspredicatedevice.
Key PatientContactingMaterial	Anchor: PEEKSuture: UHMWPE	Anchor: PEEKSuture: Polyester	Differentwhile bothdevices areevaluatedaccording toISO 10993-1
DimensionalVerification	Anchor diameter:3.7mm, 4.5mm, 5.5mm	Anchor diameter: 4.5mm,5.5mm (K093897)Anchor diameter: 3.7mm(K121018)	Substantiallyequivalent.
Anchor type	Lock-in knotless sutureanchorTwo-component anchorcomprised of an anchorbody with eyelet and aninner core	Lock-in knotless sutureanchorTwo-component anchorcomprised of an anchorbody with eyelet and aninner core	Identical aspredicatedevice.
Sterilization	EO sterilization	Irradiation sterilization	Different, butthesterilization isvalidated andsubjectdevice has aSAL of 10-6.
Shelf-life	5 Years	5 Years	Identical aspredicatedevice.
SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice.
OperatingPrinciple	Implant the anchor intothe bone to form ananchorage with thebone. The sutureconnected to the anchorcan re-suture and fix thesoft tissues such astendons and ligaments,so that they can be re-fixed on the surface ofbone.	Implant the anchor intothe bone to form ananchorage with the bone.The suture connected tothe anchor can re-sutureand fix the soft tissuessuch as tendons andligaments, so that theycan be re-fixed on thesurface of bone.	Identical aspredicatedevice.
Environment ofUse	Hospitals/clinics	Hospitals/clinics	Identical aspredicatedevice.

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VII Performance data

Non-clinical bench tests were conducted in support of the substantial equivalence

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determination.

Material Standards

The material standards are the essential part to be complied with first, as it is the basis of manufacturing surgical implants.

We have complied with the following material standards:

ASTM F2026-17: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.

Biocompatibility testing

Biocompatibility of the Javelot PEEK suture anchors was evaluated in accordance with ISO 10993-1: 2018 for the body contact category of "Implant medical device - Tissue/ bone" with a contact duration of "Long term ( > 30 d)" and "Externally communicating medical device - Tissue/ bone/ dentin" with a contact duration of "Limited (≤24 h)".

Bacterial endotoxin testing

Bacterial endotoxins for the implantable components are determined using LAL testing to meet endotoxin limit specifications.

Mechanical performance testing

The following are the mechanical tests that have been performed on the Subject device (i.e. The Javelot PK-S suture anchor) and Predicate device (i.e. Smith & Nephew's TWINFIX™ Ultra PK Suture Anchor):

• 1. Insertion testing
• 2. Pullout testing
• 3. Component interconnection testing
• 4. Fatigue testing

Sterilization and Shelf-life testing

The sterilization method has been validated according to ISO 11135:2014 to a SAL of 10-1, which has thereby determined the routine control and monitoring parameters, 5-year shelflife of the device has been evaluated by accelerated ageing test.

Safety in MRI

The Javelot PEEK suture anchors are MR safe as the polyetheretherketone material and the ultrahigh molecular weight polyethylene material are nonmetallic, nonconducting materials that do not contain ferromagnetic materials or any other metallic markers that can interfere with magnetic resonance imaging (MRI). There are no concerns with the performance of the devices in an MRI environment. These devices are labeled MR safe

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per ASTM F2503.

VIII Conclusion

The Javelot PEEK suture anchors are substantially equivalent to the predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.

Regulation Number and Section

§ 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.