Predicate Devices

K093228, K101823, K203495, K140855, K061863, K063479, K093897, K121018

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a suture anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes.
Explanation: The device is a "suture anchor" intended for "reattachment of soft tissue to bone" for various repairs in different anatomical sites, which is a therapeutic function.

Diagnostic

No.

The device is a non-absorbable suture anchor intended for the reattachment of soft tissue to bone, serving a therapeutic and reconstructive purpose rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical suture anchor made of PEEK material with a preassembled inserter. It is intended for surgical implantation to reattach soft tissue to bone. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "reattachment of soft tissue to bone" for various anatomical sites. This is a surgical procedure performed directly on the patient's body.
Device Description: The device is described as a "suture anchor" made of PEEK material with sutures, designed to be inserted into bone. This is a physical implant used during surgery.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.

The information provided describes a surgical implant used for musculoskeletal repair, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

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

MBI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Foot/Ankle, Elbow, Knee, Hand/Wrist, Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospitals/clinics

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)

Non-clinical bench tests were conducted in support of the substantial equivalence determination.
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:
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:
Determined using LAL testing to meet endotoxin limit specifications.
Mechanical performance testing:
Insertion testing
Pullout testing
Component interconnection testing
Fatigue testing
Sterilization and Shelf-life testing:
Sterilization method validated according to ISO 11135:2014 to a SAL of 10-1.
5-year shelf-life evaluated by accelerated ageing test.
Safety in MRI:
Labeled MR safe per ASTM F2503 due to nonmetallic, nonconducting materials (PEEK and UHMWPE) that do not contain ferromagnetic materials or other metallic markers.

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.

K093228, K101823, K203495, K140855, K061863, K063479, K093897, K121018

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

§ 888.3040 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.

Summary

0

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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.

3

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.

5

-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 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."

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 (301) 443-6740

EF

7

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."

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)

9

-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 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."

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 (301) 443-6740

EF

11

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, Jiangsu
Province, PEOPLE'S REPUBLIC OF CHINA |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Primary contact person: | Juan Wu
Regulatory Affairs Specialist
Phone: +86-17521559984
Email: Juan.Wu@microport.com |

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 (Javelot
PK-S suture anchor) | Predicate Device
K093228, TWINFIXTM
Ultra PK Suture Anchor | Remarks |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Code | MBI | MBI | Identical as
predicate
device. |
| Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Identical as
predicate
device. |
| Regulatory
Class | Class II | Class II | Identical as
predicate
device. |
| 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 | The Smith & Nephew
TWINFIX Ultra PK Suture
Anchor is intended for use
for the reattachment of
soft tissue to bone for the
following indications:
Shoulder:
-Bankart lesion repairs
-SLAP lesion repairs
-Acromioclavicular
separation repairs
-Rotator cuff tear repairs
-Capsular shift or
capsulolabral
reconstructions
-Biceps tenodesis
-Deltoid repairs
Foot/Ankle:
-Hallux Valgus repairs | Identical as
predicate
device. |
| | instability | -Medial or lateral
instability | |
| | repair/reconstruction | repairs/reconstructions | |
| | -Achilles tendon
repair/reconstruction | -Achilles tendon
repairs/reconstruction | |
| | -Midfoot reconstruction | -Midfoot reconstructions | |
| | -Metatarsal
ligament/tendon
repair/reconstruction | -Metatarsal
ligament/tendon
repairs/reconstructions | |
| | Elbow: | Elbow: | |
| | -Ulnar or radial collateral
ligament reconstruction | -Ulnar or radial collateral
ligament reconstructions | |
| | -Lateral epicondylitis
repair | -Lateral epicondylitis
repair | |
| | -Biceps tendon
reattachment | -Biceps tendon
reattachment | |
| | Knee: | Knee: | |
| | -Extra-capsular repair | -Extra-capsular repairs | |
| | • Medial collateral
ligament | • Medial collateral
ligament | |
| | • Lateral collateral
ligament | • Lateral collateral
ligament | |
| | • Posterior oblique
ligament | • Posterior oblique
ligament | |
| | -Iliotibial band tenodesis | -Iliotibial band tenodesis | |
| | -Patellar realignment and
tendon repair | -Patellar realignment and
tendon repairs | |
| | • Vastus medialis
obliquus advancement | • Vastus medialis
obliquus advancement | |
| Composition | Implantable part: Anchor,
suture | Implantable part: Anchor,
suture | Identical as
predicate device. |
| | Non-implantable part:
inserter | Non-implantable part:
inserter | |
| Key Patient
Contacting
Material | Anchor: PEEK
Suture: UHMWPE | Anchor: PEEK
Suture: UHMWPE | Identical as
predicate device. |
| Dimensional
Verification | Anchor diameter:
4.5mm, 5.5mm, 6.5mm
Anchor length: 19mm | Anchor diameter:
4.5mm, 5.5mm, 6.5mm
Anchor length: 19mm | Substantially
equivalent. |
| Anchor type | Screw-in suture anchor | Screw-in suture anchor | Identical as
predicate device. |
| | | | |
| Sterilization | EO sterilization | EO sterilization | Identical as
predicate
device. |
| Shelf-life | 5 Years | 5 Years | Identical as
predicate
device. |
| Single
Use/Reuse | Single Use | Single Use | Identical as
predicate
device. |
| Operating
Principle | Implant the anchor into
the bone to form an
anchorage with the bone.
The suture connected to
the anchor can re-suture
and fix the soft tissues
such as tendons and
ligaments, so that they
can be re-fixed on the
surface of bone. | Implant the anchor into
the bone to form an
anchorage with the bone.
The suture connected to
the anchor can re-suture
and fix the soft tissues
such as tendons and
ligaments, so that they
can be re-fixed on the
surface of bone. | Identical as
predicate
device. |
| Environment of
Use | Hospitals/clinics | Hospitals/clinics | Identical as
predicate
device. |

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 suture
anchor (Knotless)) | Device | Predicate Device | Remarks |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------|
| | | | K101823, SwiveLock
suture anchor
(Primary Predicate) | |
| | | | K203495, SwiveLock
suture anchor
(Secondary Predicate) | |
| Product Code | MBI | | K101823: MAI, HIWC
K203495: MAI, MBI | Different as
predicate
device
includes
absorbable
devices |
| | | | whose code | |
| | | | is different. | |
| Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Identical as
predicate
device. | |
| Regulatory
Class | Class II | Class II | Identical as
predicate
device. | |
| Indications for
use | 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 | (K101823) The Arthrex
SwiveLock Anchors are
intended for fixation of
suture (soft tissue) to
bone in the shoulder,
foot/ankle, knee,
hand/wrist, elbow, and
hip in the following
procedures:
Shoulder:
-Bankart repair
-SLAP lesion repair
-Acromio-clavicular
separation repair
-Rotator cuff repairs
-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
-Bunionectorny.
Elbow:
-Ulnar or radial collateral
ligament reconstruction | Substantially
equivalent. | |

22

23

K231002

repair	-Biceps tendon
Hand/Wrist:	reattachment
-Scapholunate ligament
reconstruction	-Tennis elbow repair
-Ulnar/Radial collateral
ligament reconstruction	-Lateral epicondylitis
repair
Knee:	Hand/Wrist:
-Medial collateral
ligament repair	-Scapholunate ligament
reconstruction
-Lateral collateral
ligament repair	-Ulnar or Radial collateral
ligament reconstruction
-Posterior oblique
ligament repair	-Radial collateral
ligament reconstruction
-Iliotibial band tenodesis	Knee:
-Patellar tendon repairs	-Medial collateral
ligament repair
-Anterior cruciate
ligament repair (4.75-
5.5mm anchors only)	-Lateral collateral
ligament repair
-Secondary or adjunct
fixation for ACL/PCL
reconstruction or repair
(4.75-5.5mm anchors
only)	-Posterior oblique
ligament repair
-Quadriceps tendon
repair (4.75 mm anchors
only)	-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 hamstring
repair(4.75-5.5mm
anchors only)	(K203495) The Arthrex
SwiveLock Anchor is
intended for fixation of
suture (soft tissue) to
bone in the shoulder,
foot/ankle, knee,
hand/wrist, elbow, and
hip in skeletally mature
pediatric and adult
patients for the following
procedures:
-Gluteus Medius Repair
(4.75-5.5mm anchors
only)	Shoulder:
	-Bankart repair
	-SLAP lesion repair
	-Acromio-clavicular
separation repair
-Rotator cuff repair
-Capsular shift or
capsulolabral
reconstruction
-Biceps tenodesis
capsulolabral
reconstruction
-Deltoid repair
Foot/ Ankle:
-Hallux Valgus repair
-Medial stabilization
-Lateral stabilization
-Achilles tendon
reconstruction,
-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(4.75-5.5

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
			predicate
device.
Shelf-life	5 Years	5 Years	Identical as
predicate
device.
Single
Use/Reuse	Single Use	Single Use	Identical as
predicate
device.
Operating
Principle	Implant the anchor into
the bone to form an
anchorage with the bone.
The suture
connected to the anchor
can re-suture and fix the
soft tissues such as
tendons and ligaments,
so that they can be re-
fixed on the surface of
bone.	Implant the anchor into
the bone to form an
anchorage with the bone.
The suture connected to
the anchor can re-suture
and fix the soft tissues
such as tendons and
ligaments, so that they
can be re-fixed on the
surface of bone.	Identical as
predicate
device.
Environment of
Use	Hospitals/clinics	Hospitals/clinics	Identical as
predicate
device.

26

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

| Characteristics | Subject
(Javelot PK-P suture
anchor) | | Predicate Device | Remarks |
|-------------------|--------------------------------------------|--|-------------------------------------------------|------------------------------------------------------------------------------|
| Product Code | MBI | | K140855, SutureTak
Suture Anchor
MBI, MAI | Different as predicate device includes absorbable devices whose code is MAI. |
| Regulation Number | 21 CFR 888.3040 | | 21 CFR 888.3040
21 CFR 888.3030 | Different as predicate device includes absorbable |

27

K231002

| Regulatory
Class | Indications for
use | Class II | Class II | devices |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | | | Identical as
predicate
device. |
| | | 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 | The Arthrex SutureTak
suture anchors are
intended to be used for
suture (soft tissue)
fixation to bone in the
foot, ankle, knee, hand,
wrist, elbow, shoulder,
and hip.
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
-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 | Identical as
predicate
device. |
| | reconstruction | -Iliotibial band tenodesis | | |
| | -Carpal ligament
reconstruction | Hand/Wrist:
-Scapholunate ligament
reconstruction | | |
| | -Repair/Reconstruction
of collateral ligaments | -Carpal ligament
reconstruction | | |
| | -Repair of flexor and
extensor tendons at the
PIP, DIP, and MCP joints
for all digits | -Repair/Reconstruction
of collateral ligaments | | |
| | -Digital tendon transfers
Elbow:
-Biceps tendon
reattachment | -Repair of flexor and
extensor tendons at the
PIP, DIP, and MCP joints
for all digits | | |
| | -Ulnar or radial collateral
ligament reconstruction
Hip:
-Capsular repair
-Acetabular labral repair | -Digital tendon transfers
Elbow:
-Biceps tendon
reattachment | | |
| | | -Ulnar or radial collateral
ligament reconstruction
Hip:
-Capsular repair
-Acetabular labral repair | | |
| 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:
2.0mm, 2.4mm, 3.0mm | Anchor diameter: 2.0mm,
2.4mm, 3.0mm | Substantially
equivalent. | |
| Anchor type | Push-in suture anchor | Push-in suture anchor | Identical as
predicate
device. | |
| Sterilization | EO sterilization | EO sterilization | Identical as
predicate
device. | |
| Shelf-life | 5 Years | 5 Years | Identical as
predicate
device. | |
| Single
Use/Reuse | Single Use | Single Use | Identical as
predicate
device. | |
| | | | device. | |
| Operating
Principle | Implant the anchor into
the bone to form an
anchorage with the
bone. The suture
connected to the anchor
can re-suture and fix the
soft tissues such as
tendons and ligaments,
so that they can be re-
fixed on the surface of
bone. | Implant the anchor into
the bone to form an
anchorage with the bone.
The suture connected to
the anchor can re-suture
and fix the soft tissues
such as tendons and
ligaments, so that they
can be re-fixed on the
surface of bone. | Identical as
predicate
device. | |
| Environment of
Use | Hospitals/clinics | Hospitals/clinics | Identical as
predicate
device. | |

28

29

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

| Characteristics | Subject
(Javelot PK-P suture
anchor (Knotless)) | Device | Predicate Device | Remarks |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Product Code | MBI | | K061863: HWC, MBI,
JDR, MAI
K063479: HWC, MAI,
MBI | Different as predicate
device includes
absorbable devices
whose code is different. |
| Regulation
Number | 21 CFR 888.3040 | | 21 CFR 888.3040 | Identical as
predicate device. |
| Regulatory
Class | Class II | | Class II | Identical as
predicate device. |
| Indications
for | The Javelot PK-P suture | | (K061863) | Substantially |
| use | 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 | The Arthrex PushLock™,
previously cleared under
510(k) K051219, is
intended for fixation of
suture (soft tissue) to
bone in the shoulder,
foot/ankle, knee,
hand/wrist, elbow, hip,
and pelvis in the following
procedures:
Shoulder:
-Bankart repair
-SLAP lesion repair
-Acromio-clavicular
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
-Bunionectomy
Elbow:
-Ulnar or radial collateral
ligament reconstruction
-Biceps tendon
reattachment
-Tennis elbow repair
-Lateral epicondylitis
repair
Hand/ Wrist:
-Scapholunate ligament | equivalent. | |

30

31

K231002

| ligament reconstruction
(2.9-4.5mm anchors

only)	reconstruction
-Radial collateral
ligament reconstruction
(2.9-4.5mm anchors
only)	-Ulnar collateral ligament
reconstruction			reconstruction
-Carpal ligament
reconstruction (2.5mm
anchors only)	-Radial collateral
ligament reconstruction			-Carpal Ligament
Reconstruction
-Repair/Reconstruction
of collateral ligaments
(2.5mm anchors only)	Knee:			-Repair/Reconstruction
of collateral ligaments
-Repair of Flexor and
Extensor Tendons at the
PIP, DIP and MCP joints
for all digits (2.5mm
anchors only)	-Medial collateral
ligament repair			-Repair of Flexor and
Extensor Tendons at the
PIP, DIP and MCP joints
for all digits
-Digital tendon transfers
(2.5mm anchors only)	-Lateral collateral
ligament repair			-Digital tendon transfers
Knee:	-Posterior oblique
ligament repair			Knee:
-Medial collateral
ligament repair	-Iliotibial band tenodesis			-Medial collateral
ligament repair
-Lateral collateral
ligament repair	-Patellar tendon repairs			-Lateral collateral
ligament repair
-Posterior oblique
ligament repair	Hip:			-Posterior oblique
ligament repair
-Iliotibial band tenodesis	-Capsular repair			-Iliotibial band tenodesis
-Patellar tendon repairs	-Acetabular labral repair			-Patellar tendon repair
Hip:
(2.9-4.5mm
anchors only)	Pelvis:	Composition	Implantable part: Anchor
Non-implantable part:
inserter	Implantable part: Anchor
Non-implantable part:
inserter	Identical as
predicate
device.
-Acetabular labral repair	Bladder Neck
Suspension for female
urinary incontinence due
to urethral hypermobility
or intrinsic sphincter
deficiency	Key Patient
Contacting
Material	Anchor: PEEK	Anchor: PEEK	Identical as
predicate
device.
-Capsular repair	(K063479) The Arthrex
PushLock™ is intended
to be used for suture or
tissue fixation in the foot,
ankle, knee, hand, wrist,
elbow, shoulder, and in
select maxillofacial
applications. Specific
indications are listed
below:	Dimensional
Verification	Anchor diameter:
2.5mm, 2.9mm, 3.5mm,
4.5mm	K061863, Anchor
diameter:
2.9mm,
3.5mm, 4.5mm
K063479, Anchor
diameter: 2.5mm	Substantially
equivalent.
	Skull:	Anchor type	Push-in knotless suture
anchor
Two-component anchor
comprised of an eyelet
and a hollow anchor
body	Push-in knotless suture
anchor
Two-component anchor
comprised of an eyelet
and a hollow anchor body	Identical as
predicate
device.
	-Stabilization and fixation
of oral cranio-
maxillofacial skeletal
bone	Sterilization	EO sterilization	Irradiation sterilization	Different, but
the
sterilization is
validated and
subject
	-Mandible and

maxillofacial bones
-Lateral Canthoplasty
-Repair of Nasal
Vestibular Stenosis
-Brow Lift
-Temporomandibular Joint (TMJ) reconstruction
-Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
Shoulder:
-Bankart repair
-SLAP lesion repair
-Acromio-clavicular 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
-Digital tendon transfers
Elbow:
-Ulnar or radial collateral ligament reconstruction
-Biceps tendon reattachment
Hand/ Wrist:
-Scanbolunate ligament

32

33

34

| | | | device has a
SAL of $10^{-6}$ . |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Shelf-life | 5 Years | 5 Years | Identical as
predicate
device. |
| Single
Use/Reuse | Single Use | Single Use | Identical as
predicate
device. |
| Operating
Principle | Implant the anchor into
the bone to form an
anchorage with the
bone. Connect
appropriate suture to the
anchor to re-suture and
fix the soft tissues such
as tendons and
ligaments, so that the
soft tissues can be re-
fixed on the surface of
bone. | Implant the anchor into
the bone to form an
anchorage with the bone.
Connect appropriate
suture to the anchor to re-
suture and fix the soft
tissues such as tendons
and ligaments, so that the
soft tissues can be re-
fixed on the surface of
bone. | Identical as
predicate
device. |
| Environment of
Use | Hospitals/clinics | Hospitals/clinics | Identical as
predicate
device. |

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

| Characteristics | Subject
(Javelot PK-L suture
anchor (Knotless)) | Predicate Device | Remarks |
|-----------------|-------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | | K093897, FOOTPRINT
Ultra Suture Anchor
(Primary Predicate) | |
| | | K121018, BIORAPTOR
Knotless Suture Anchor
(Secondary Predicate) | |
| Product Code | MBI | MBI (K093897)
MAI, MBI (K121018) | Different as
K121018
includes
other
devices
whose code
is MAI. |

35

K231002

| Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Identical as
predicate
device. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Regulatory
Class | Class II | Class II | Identical as
predicate
device. |
| Indications for
use | 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 | The Smith & Nephew
FOOTPRINT Ultra PK
Suture
Anchor
(K093897) is intended for
use for the reattachment
of soft tissue to bone for
the following indications:
Shoulder:
-Bankart repair
-SLAP lesion repair
-Acromio-clavicular
separation
-Rotator cuff repair
-Capsular shift or
capsulolabral
reconstruction
-Biceps tenodesis
-Deltoid repair
Foot/Ankle:
-Hallux Valgus repairs
-Medial stabilization
-Lateral stabilization
-Achilles tendon repair
-Mid-foot reconstructions
-Metatarsal ligament
repair
Elbow:
-Ulnar or radial collateral
ligament reconstruction
-Biceps tendon
reattachment
Hand/Wrist:
-Scapholunate ligament
reconstruction
-Ulnar collateral ligament | Substantially
equivalent. |

36

-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

37

| | | -Metatarsal
ligament/tendon
repairs/reconstructions
-Bunionectomy
Elbow, Wrist, and
Hand:
-Ulnar or radial collateral
ligament reconstructions
-Lateral epicondylitis
repair
-Biceps tendon
reattachment
Knee:
-Extra-capsular repairs
• Medial collateral
ligament
• Lateral collateral
ligament
• Posterior oblique
ligament
-Iliotibial band tenodesis
-Patellar realignment and
tendon repairs
• Vastus medialis
obliquous
advancement
Hip:
-Hip capsule repair
• Acetabular labrum
reattachment/
reconstruction | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Composition | Implantable part: Anchor
Non-implantable part:
suture, inserter | Implantable part: Anchor
Non-implantable part:
suture, inserter | Identical as
predicate
device. |
| Key Patient
Contacting
Material | Anchor: PEEK
Suture: UHMWPE | Anchor: PEEK
Suture: Polyester | Different
while both
devices are
evaluated
according to
ISO 10993-
1 |
| Dimensional
Verification | Anchor diameter:
3.7mm, 4.5mm, 5.5mm | Anchor diameter: 4.5mm,
5.5mm (K093897)
Anchor diameter: 3.7mm
(K121018) | Substantially
equivalent. |
| Anchor type | Lock-in knotless suture
anchor
Two-component anchor
comprised of an anchor
body with eyelet and an
inner core | Lock-in knotless suture
anchor
Two-component anchor
comprised of an anchor
body with eyelet and an
inner core | Identical as
predicate
device. |
| Sterilization | EO sterilization | Irradiation sterilization | Different, but
the
sterilization is
validated and
subject
device has a
SAL of 10-6. |
| Shelf-life | 5 Years | 5 Years | Identical as
predicate
device. |
| Single
Use/Reuse | Single Use | Single Use | Identical as
predicate
device. |
| Operating
Principle | Implant the anchor into
the bone to form an
anchorage with the
bone. The suture
connected to the anchor
can re-suture and fix the
soft tissues such as
tendons and ligaments,
so that they can be re-
fixed on the surface of
bone. | Implant the anchor into
the bone to form an
anchorage with the bone.
The suture connected to
the anchor can re-suture
and fix the soft tissues
such as tendons and
ligaments, so that they
can be re-fixed on the
surface of bone. | Identical as
predicate
device. |
| Environment of
Use | Hospitals/clinics | Hospitals/clinics | Identical as
predicate
device. |

38

VII Performance data

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

39

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
1. Pullout testing
1. Component interconnection testing
1. 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

40

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.