(57 days)
No
The device description and performance studies focus on mechanical properties and material composition, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes.
The device is intended for connection and fixation of soft tissue to bone for various repairs and reconstructions, which are therapeutic interventions.
No
Explanation: The device is described as a "Suture Anchor" intended for "connection and fixation of soft tissue to bone." Its function is to facilitate surgical repair, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium, stainless steel, polycarbonate, and polyphenylsulfone, which are hardware materials. The device is a suture anchor system, not a software application.
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 "connection and fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (suture anchor) and associated tools for insertion. It does not involve testing or analyzing samples taken from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process related to in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / 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
- · 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
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, hip, shoulder, elbow, ankle, foot, wrist and hand
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:
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:
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 torque
-
- Failure torque
-
- Static pullout strength
-
- Cyclic pullout strength
Sterilization and Shelf-life testing:
Validated according to ISO 11135:2014 to a SAL of 10-5. 5-year shelflife evaluated by accelerated ageing test.
Safety in MRI:
Evaluated for safety in the MR environment based on the FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards. Tested for magnetically induced force, magnetically induced torque, heating by RF fields, and image artifact.
MRI safety confirmed for sutures made of ultrahigh molecular weight polyethylene material (nonmetallic, nonconducting) 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.
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.
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
§ 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.
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):
-
- Insertion torque
-
- Failure torque
-
- Static pullout strength
-
- 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.