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)

Q: Who is the manufacturer of 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)?

Suzhou Endophix Co., Ltd. filed the 510(k) submission for 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) (K231002).

Q: What is the FDA product code for 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)?

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

Q: What is the regulatory pathway for 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)?

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

Q: What are the predicate devices for 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)?

TWINFIX Ultra PK Suture Anchor (K093228); Arthrex Swivelock Anchors (K101823); Arthrex SwiveLock Suture Anchor (K203495); Arthrex SutureTak Suture Anchors (K140855); Arthrex PushLock (K061863); Arthrex 2.5mm PushLock (K063479); FOOTPRINT Ultra PK Suture Anchor (K093897); BIORAPTOR Knotless Suture Anchor (K121018).

Q: Who can help prepare an FDA 510(k) submission like 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)?

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.

K231002 · Suzhou Endophix Co., Ltd. · MBI · Jun 7, 2023 · Orthopedic

Device Facts

Record ID	K231002
Device Name	Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
Applicant	Suzhou Endophix Co., Ltd.
Product Code	MBI · Orthopedic
Decision Date	Jun 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Device consists of PEEK suture anchors preassembled on inserters (stainless steel rod, ABS handle) with non-absorbable UHMWPE sutures; used for reattaching soft tissue to bone. Inserter creates pilot hole; anchor is inserted via screw-in or push-in mechanism to provide fixation. Used in hospitals/clinics by surgeons. Output is mechanical fixation of soft tissue to bone; aids in healing/reconstruction of tendons/ligaments. Benefits include secure tissue reattachment. MR safe per ASTM F2503.

Clinical Evidence

Bench testing only. Testing included insertion, pullout, component interconnection, and fatigue testing. Biocompatibility evaluated per ISO 10993-1. Sterilization validated per ISO 11135 to SAL 10^-6. Shelf-life validated via accelerated aging.

Technological Characteristics

Materials: PEEK (ASTM F2026) and UHMWPE (ASTM F2848). Design: Screw-in or push-in suture anchors. Dimensions: 2.0mm to 6.5mm diameters. Sterilization: EO (ISO 11135). Connectivity: None. Energy: None (mechanical).

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, foot/ankle, elbow, hand/wrist, knee, and hip procedures. Specific indications vary by anchor model (PK-S, PK-S Knotless, PK-P, PK-P Knotless, PK-L Knotless) and size, including repairs for rotator cuff, Bankart, SLAP, biceps tenodesis, ligament reconstructions, and tendon repairs in skeletally mature patients.

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 PK Suture Anchor (K093228)
Arthrex Swivelock Anchors (K101823)
Arthrex SwiveLock Suture Anchor (K203495)
Arthrex SutureTak Suture Anchors (K140855)
Arthrex PushLock (K061863)
Arthrex 2.5mm PushLock (K063479)
FOOTPRINT Ultra PK Suture Anchor (K093897)
BIORAPTOR Knotless Suture Anchor (K121018)

Related Devices

K232725 — Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor · Suzhou Endophix Co., Ltd. · Nov 2, 2023
K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor · Riverpoint Medical · Oct 29, 2024
K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR · Smith & Nephew Inc., Endoscopy Div. · Apr 19, 2010
K070758 — STRYKER PEEK ZIP SUTURE ANCHOR · Stryker Endoscopy · May 16, 2007
K061349 — OPUS LABRALOCK P KNOTLESS FIXATION DEVICE · Arthrocare Corp. · Jul 14, 2006

Submission Summary (Full Text)

{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) | | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ## 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*) | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| ## 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*) | <div style="display:inline-block;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:inline-block;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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 | | | |…

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)

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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)

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