Who is the manufacturer of Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

Suzhou Endophix Co., Ltd. filed the 510(k) submission for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor (K232725).

What is the FDA product code for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

TWINFIX Ultra Ti Suture Anchor (K100159); PeBA Anchor/ Suture Combination (K152566).

Who can help prepare an FDA 510(k) submission like Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor

K232725 · Suzhou Endophix Co., Ltd. · MBI · Nov 2, 2023 · Orthopedic

Device Facts

Record ID	K232725
Device Name	Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
Applicant	Suzhou Endophix Co., Ltd.
Product Code	MBI · Orthopedic
Decision Date	Nov 2, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - Bankart lesion repair - SLAP lesion repair - Acromio-clavicular separation repair - Rotator cuff tear repair - Capsular shift or capsulolabral reconstruction - Biceps tenodesis - Deltoid repair Foot and Ankle: Hallux valgus repair - Medial or lateral instability repair/reconstruction - Achilles tendon repair/reconstruction - Midfoot reconstruction - Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: Ulnar or radial collateral ligament reconstruction - Lateral epicondylitis repair - Biceps tendon reattachment - Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) 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 Hip: (2.8-6.5mm anchors only) - Capsular repair - Acetabular labral repair

Device Story

Titanium suture anchors preassembled on inserters; used for soft tissue-to-bone fixation in orthopedic procedures (knee, hip, shoulder, elbow, ankle, foot, wrist, hand). Surgeon implants anchor into bone; inserter removed; suture remains to secure tissue. Used in hospitals/clinics by orthopedic surgeons. Provides mechanical fixation of tendons/ligaments to bone surface. Benefits patient by restoring anatomical attachment and stability. MR safe.

Clinical Evidence

Bench testing only. Performance data includes insertion torque, failure torque, static pullout strength, and cyclic pullout strength. Biocompatibility evaluated per ISO 10993-1. MR safety evaluated per FDA guidance and ASTM standards. Sterilization validated per ISO 11135.

Technological Characteristics

Materials: Titanium alloy (ISO 5832-3), UHMWPE (ASTM F2848), Stainless Steel (ASTM F899), Polysulfone (ASTM F702). Principle: Mechanical bone fixation via threaded anchor. Form factor: Various diameters (2.0mm-6.5mm). Sterilization: Ethylene Oxide (EO). No software/algorithm.

Indications for Use

Indicated for soft tissue-to-bone fixation in knee, hip, shoulder, elbow, ankle, foot, wrist, and hand for patients requiring repair of ligaments, tendons, or capsular structures (e.g., Bankart, SLAP, rotator cuff, Achilles, hallux valgus, epicondylitis). Hip indications restricted to 2.8-6.5mm anchors.

Regulatory Classification

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.

Predicate Devices

TWINFIX Ultra Ti Suture Anchor (K100159)
PeBA Anchor/ Suture Combination (K152566)

Reference Devices

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 (K152566)
TWINFIX Ti Suture Anchor (K053344)

Related Devices

K141011 — G-FORCE GEN 2 SUTURE ANCHOR SYSTEM · Wrightmedicaltechnologyinc · Jul 30, 2014
K252664 — GMReis Suture Anchors · GM Dos Reis Industria e Comercio Ltda. · Nov 4, 2025
K111661 — ARTHREX SCAPHOLUNATE ANCHOR · Arthrex, Inc. · Aug 19, 2011
K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR · Smith & Nephew Inc., Endoscopy Div. · Apr 19, 2010
K171465 — Stryker Self-Punching ICONIX · Stryker · Aug 24, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ November 2, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety. Suzhou Endophix Co., Ltd. Juan Wu Regulatory Affairs Specialist No. 151. Fengli Road. SIP Suzhou, Jiangsu 215000 China Re: K232725 Trade/Device Name: Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 4, 2023 Received: September 6, 2023 Dear Mr. 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Digitally signed by Jesse Muir -S Jesse Muir -S Date: 2023.11.02 16:08:18 -04'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Enclosure {3}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K232725 #### Device Name Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor #### Indications for Use (Describe) The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - · Bankart lesion repair - · SLAP lesion repair - · Acromio-clavicular separation repair - · Rotator cuff tear repair - · Capsular shift or capsulolabral reconstruction - · Biceps tenodesis - · Deltoid repair Foot and Ankle: - Hallux valgus repair - · Medial or lateral instability repair/reconstruction - · Achilles tendon repair/reconstruction - · Midfoot reconstruction - · Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - · Lateral epicondylitis repair - · Biceps tendon reattachment - · Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) 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 Hip: (2.8-6.5mm anchors only) - · 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {5}------------------------------------------------ # 510(k) Summary ## I 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: | 2023-09-04 | ## II Device | Trade Name: | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | |----------------------|------------------------------------------------------| | 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 ### 1. Predicates for Javelot Ti Suture Anchor ### Primary predicate | Trade Name: | TWINFIX Ultra Ti Suture Anchor | |-------------------------|--------------------------------------| | Common Name: | Suture Anchor | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K100159 | | Manufacturer: | Smith & Nephew, Inc., Endoscopy DIV. | #### Reference device | Trade Name: | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | |-------------------------|----------------------------------------------| | Common Name: | suture anchor | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K152566 | | Manufacturer: | Smith & Nephew, Inc., Endoscopy DIV. | {6}------------------------------------------------ ### 2. Predicates for Javelot Ti-D Suture Anchor #### Primary predicate | Trade Name: | PeBA Anchor/ Suture Combination | |-------------------------|-------------------------------------| | Common Name: | suture anchor | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | MBI | | Premarket Notification: | K152566 | | Manufacturer: | Smith & Nephew, Inc., Endoscopy DIV | #### Reference device | Trade Name: | TWINFIX Ti Suture Anchor | |-------------------------|-------------------------------------| | Common Name: | Suture Anchor | | Classification: | Class II, 21 CFR 888.3040 | | Product Code: | HWC, JDR, MAI, MBI | | Premarket Notification: | K053344 | | Manufacturer: | Smith & Nephew, Inc., Endoscopy DIV | #### IV Device description Javelot titanium anchors and sutures are preassembled onto an inserter, which enables insertion of the anchor into bone. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and the suture looped through the anchor. Javelot titanium suture anchors come in various configurations, including: with attached non-absorbable needle(s). In certain configurations, the Javelot titanium suture anchors are packaged with a drill, a drill guide and a drill guide handle. The anchors are offered in titanium material. The sutures are offered in non-absorbable USP braid Ultra High Molecular Weight Polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rods are offered in stainless steel material, the insertion handles are offered in polycarbonate (PC) material. The needles are offered in 302 stainless steel material, the drills are offered in 630 stainless steel material, the drill guides are offered in 304 stainless steel material, and the drill guide handles are offered in polyphenylsulfone (PPSU) material. Javelot titanium suture anchors are provided sterile, non-absorbable, for single use only. ### V Indications for use The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: #### Shoulder: - . Bankart lesion repair - . SLAP lesion repair {7}------------------------------------------------ - . Acromio-clavicular separation repair - Rotator cuff tear repair - Capsular shift or capsulolabral reconstruction . - Biceps tenodesis . - Deltoid repair . #### Foot and Ankle: - Hallux valgus repair - Medial or lateral instability repair/reconstruction - Achilles tendon repair/reconstruction - Midfoot reconstruction - Metatarsal ligament/tendon repair/reconstruction #### Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - . Lateral epicondylitis repair - . Biceps tendon reattachment - . Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) #### Knee: - . Extra-capsular repair - Medial collateral ligament - Lateral collateral liqament - Posterior oblique ligament - . Iliotibial band tenodesis - . Patellar realignment and tendon repair - Vastus medialis obliquus advancement #### Hip: (2.8-6.5mm anchors only) - . Capsular repair - Acetabular labral repair . ### VI Comparison of technological characteristics with the predicate devices Javelot Ti suture anchor and Javelot Ti-D suture anchor have similar technological characteristics and fundamental design as the predicate devices. 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 Ti Suture Anchor) | Predicate Device K100159, TWINFIX Ultra Ti Suture Anchor | Remarks | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | | | (Primary Predicate) | | | | | K152566, OBL 2.0 MM MINI TAC ANCHOR, MODEL 10- 1629-01 (Reference Device) | | | 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. | | Indications for use | The Javelot Ti and Javelot Ti- D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: | Primary Predicate: TWINFIX Ultra Ti Suture Anchor (K100159) is intended for use for the reattachment of soft tissue to bone for the following indications: | Identical as predicate device. | | | Shoulder: | Shoulder: | | | | • Bankart lesion repair • SLAP lesion repair • Acromio-clavicular separation repair • Rotator cuff tear repair • Capsular shift or capsulolabral reconstruction • Biceps tenodesis • Deltoid repair | Bankart lesion repairs, SLAP lesion repairs, Acromio- clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs | | | | Foot and Ankle: | Foot and Ankle: | | | | • Hallux valgus repair • Medial or lateral instability repair/reconstruction • Achilles tendon repair/reconstruction • Midfoot reconstruction | Hallux valgus repairs, Medial or lateral instability repairs, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions | | Table 1 Substantial equivalence discussion - Javelot Ti Suture Anchor {8}------------------------------------------------ {9}------------------------------------------------ | Metatarsal ligament/tendon repair/reconstruction | Elbow, Wrist, and Hand: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Elbow, Wrist and Hand: Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) | Knee: Extra-capsular repairs: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, Iliotibial band tenodesis, Patellar realignment and tendon repairs, including vastus medialis obliquous advancement | | 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 | Reference Device: The OBL Preloaded Series Anchor (K152566) is intended for use only for the fixation of nonabsorbable synthetic suture material for the following indications: | | Hip: (2.8-6.5mm anchors only) Capsular repair Acetabular labral repair | Shoulder: Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs | | | Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal | {10}------------------------------------------------ | | | ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: Scapholunate ligament reconstructions, 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, including vastus medialis obliquous advancement | | | | | | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Composition | Implantable parts: anchor, suture Non-implantable parts: inserter, instruments, needles | Implantable parts: anchor, suture Non-implantable parts: inserter, instruments, needles | Identical as predicate device. | Anchor thread | Single thread | Single thread | Identical as predicate device. | | Key Patient Contacting Material | Anchor: Titanium alloy TI6AL4VELI Suture: UHMWPE | K100159 (TWINFIX Ultra Ti Suture Anchor) Anchor: Titanium alloy TI6AL4VELI Suture: UHMWPE K152566 (OBL Preloaded Series Anchor) Anchor: Titanium alloy TI6AL4VELI Suture: UHMWPE, polyester. | Substantially equivalent. | Dimensional Verification | Anchor diameter: 4.5mm, 5.5mm, 6.5mm Anchor length: 19.3mm, 19.4mm, 19.5mm Suture size: #2 suture Anchor diameter: 2.0mm Anchor length: 6.8mm Suture size: #2-0 suture | K100159 (TWINFIX Ultra Ti Suture Anchor) Anchor diameter: 4.5mm, 5.5mm, 6.5mm Anchor length: 19.2mm, 19.4mm, 19.5mm Suture size: #2 suture K152566 (OBL Preloaded Series Anchor) Anchor diameter: 2.0mm Anchor length: 6.8mm Suture size: #3-0 suture, #2-0 suture | Substantially equivalent. | | Anchor picture | Image: [anchor] | Image: [anchor] | Similar as predicate device. | Sterilization | EO sterilization | EO sterilization, Irradiation sterilization | Substantially equivalent, 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 | Implant the anchor into the bone to form an anchorage with the bone. The suture connected to the anchor can | Identical as predicate device. | | | | | {11}------------------------------------------------ # K232725 {12}------------------------------------------------ | | re-suture and fix the soft tissues such as tendons and ligaments, so that they can be re-fixed on the surface of bone. | re-suture and fix the soft tissues such as tendons and ligaments, so that they can be re-fixed on the surface of bone. | | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. | Table 2 Substantial equivalence discussion - Javelot Ti-D Suture Anchor | Characteris tics | Subject Device (Javelot Ti- D Suture Anchor) | Predicate Device | Remarks | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | | | K152566, PeBA Anchor/ Suture Combination (Primary Predicate) K053344, TwinFix 2.8mm, 3.5mm and BioRaptor 2.9mm Suture Anchors (Reference Device) | | | 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. | | Indications for use | The Javelot Ti and Javelot Ti- D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: • Bankart lesion repair • SLAP lesion repair • Acromio-clavicular separation repair | Primary Predicate: The PeBA Series Anchor/ Suture (K152566) Combination is intended for the fixation of surgical suture material for the following indications: Shoulder: Bankart lesion repairs, SLAP lesion repairs, Acromio- clavicular separation repairs, Rotator cuff tear repairs | Substantially equivalent. | {13}------------------------------------------------ | Rotator cuff tear repair Capsular shift or capsulolabral reconstruction Biceps tenodesis Deltoid repair Foot and Ankle: Hallux valgus repair Medial or lateral instability repair/reconstruction Achilles tendon repair/reconstruction Midfoot reconstruction Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) 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 Hip: (2.8-6.5mm anchors only) | Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions Elbow, Wrist, and Hand: Scapholunate ligament reconstructions, 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, including vastus medialis obliquous advancement Reference Device: TwinFix Ti 2.8 & 3.5mm Suture Anchor (K053344) is intended for use for the reattachment of soft tissue to bone for the following indications: | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Capsular repair Acetabular labral repair | Shoulder: Bankart lesion repairs, SLAP lesion repairs, Acromio- clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs, Anterior Shoulder Instability Repair Foot and Ankle: Hallux valgus repairs, Medial or lateral instability repairs, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, 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, including vastus medialis obliquous advancement Hip: | | {14}------------------------------------------------ {15}------------------------------------------------ | | | labral repair | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Composition | Implantable parts: anchor, suture Non-implantable parts: inserter, needle | Implantable parts: anchor, suture Non-implantable parts: inserter, needle | Identical as predicate device. | | Key Patient Contacting Material | Anchor: Titanium alloy TI6AL4VELI Suture: UHMWPE | Anchor: Titanium alloy TI6AL4VELI Suture: UHMWPE | Substantially equivalent. | | Anchor picture | Image: anchor | Image: anchor | Similar as predicate device. | | | Image: anchor | Image: anchor | | | | Image: anchor | Image: anchor | | | Anchor thread | Double thread | Double thread | Identical as predicate device. | | Dimensional Verification | Anchor diameter: 2.8mm, 3.5mm, 5.0mm, 6.5mm Anchor length: 8.9mm, 13.2mm, 15.7mm, 18.9mm Suture size: #2-0 suture, #2 suture | Anchor diameter: 2.8mm, 3.5mm, 5.0mm, 6.5mm Anchor length: 8.9mm, 13.2mm, 15.7mm, 18.9mm Suture size: #2-0 suture, #2 suture | Substantially equivalent. | | Sterilization | EO sterilization | EO sterilization | Identical as predicate device. | | Shelf-life | 5 Years | 5 Years | Identical as predicate device. | | Single Use | Single Use | Single Use | Identical as predicate device. | | Use/Reuse | | 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. | {16}------------------------------------------------ ### VII Performance data Non-clinical bench tests were conducted in support of the substantial equivalence determination. #### Material Standards The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants. We have complied with the following material standards: ISO 5832-3:2021 Implants for surgery - Metallic materials Part 3: Wrought titanium 6aluminium 4-vanadium alloy ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns. ASTM F899-20: Standard Specification for Wrought Stainless Steels for Surgical Instruments ASTM F702-18: Standard Specification for Polysulfone Resin for Medical Applications #### Biocompatibility testing Biocompatibility of the Javelot titanium suture anchor 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. {17}------------------------------------------------ The Subject devices are not labeled as non-pyrogenic or pyrogen free. #### Mechanical performance testing The following are the mechanical tests that have been performed on the Subject device (i.e. The Javelot Ti suture anchor) and Predicate device (i.e. Smith & Nephew's TWINFIX Ultra Ti Suture Anchor): - 1. Insertion torque - 2. Failure torque - 3. Static pullout strength - 4. Cyclic pullout strength #### Sterilization and Shelf-life testing The sterilization method has been validated according to ISO 11135:2014 to a SAL of 10-5, 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 anchors of Javelot titanium suture anchors have been evaluated for safety in the MR environment. These titanium anchors were evaluated based on the FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards, and worst-case devices were selected for testing. Devices were tested for magnetically induced force, maqnetically induced torque, heating by RF fields, and image artifact. The sutures of Javelot titanium suture anchors are MR safe as 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. ### VIII Conclusion The Javelot titanium suture anchor is 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.