(54 days)
Not Found
No
The device description and performance studies focus on the material properties, mechanical performance, and sterilization of a physical implant (interference screw and sheath). There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, an interference screw, is specifically indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during various surgical procedures, which directly addresses medical conditions to restore function or provide treatment.
No
This device is an implantable screw used for surgical fixation of soft tissue to bone, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of PEEK material, intended for surgical use. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for the reattachment of tissues during various orthopedic procedures. This is a therapeutic and structural function within the body.
- Device Description: The device is described as a non-absorbable implant made of PEEK material, designed to be placed inside the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to diagnose diseases or conditions. This device is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures:
Knee
-ACL Repair
-PCL Repair
-Extra-capsular repair
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
-Patellar realignment and tendon repair - Vastus medialis obliquus advancement
-Iliotibial band tenodesis
Shoulder
-Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repair
- Capsular shift or capsulolabral reconstruction
-Acromioclavicular separation repair
-Deltoid repair
-Rotator cuff tear repair
-Biceps tenodesis
Foot and Ankle
-Hallux valgus repair
-Medial or lateral instability repair/reconstruction
-Achilles tendon repair/reconstruction
-Midfoot reconstruction
-Metatarsal ligament/tendon repairs/reconstruction
-Bunionectomy
- -Flexor Hullucis Longus (FLH)
- -Tendon Transfer
Elbow, Wrist, and Hand
-Biceps tendon reattachment
-Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- -Scapholunate ligament reconstruction
- -Tendon Transfer
- -Carpometacarpal Joint Arthroplasty
- -Carpal Ligament Reconstruction
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only.
The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length.
The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath.
The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.
The models of Syntheface PEEK Interference Screws and Syntheface PEEK Screw Sheath are listed as below:
Trade name: Syntheface PEEK Interference Screw
Model:
MS-2025PS-6
MS-2025PS-7
MS-2025PS-8
MS-2025PS-9
MS-2025PS-10
MS-2025PS-11
Trade name: Syntheface PEEK Screw Sheath
Model:
MS2025PW-6
MS2025PW-8
MS2025PW-10
MS2025PW-12
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Shoulder, Foot and Ankle, Elbow, 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: ASTM F2026-17: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant 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)".
Bacterial endotoxin testing: Determined using LAL testing to meet endotoxin limit specifications.
Mechanical performance testing:
- Screw-in test
- Pullout test
- Fatigue test
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 Syntheface PEEK Interference Screw and Syntheface PEEK Screw Sheath are MR safe as the polyetheretherketone material is nonmetallic, nonconducting materials that do not contain ferromagnetic materials or any other metallic markers that can interfere with magnetic resonance imaging (MRI). These devices are labeled MR safe per ASTM F2503.
Conclusion: The Syntheface PEEK Interference Screw and Syntheface PEEK Screw Sheath are substantially equivalent to the predicate devices. The non-clinical testing demonstrates that the devices are as safe, as effective and performs as well as the legally marketed devices.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
May 23,2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
Suzhou Endophix Co., Ltd. Juan Wu Regulatory Affairs NO. 151, Fengli Road Suzhou, Jiangsu 215000 China
Re: K230874
Trade/Device Name: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: March 30, 2023 Received: March 30, 2023
Dear Juan 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.
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
1
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 medical devices and radiation-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,
Sara S. Thompson -S
For
Yu-Chieh Chiu, Ph.D. Acting 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
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230874
Device Name Syntheface PEEK Interference Screw
Indications for Use (Describe)
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures:
Knee
-ACL Repair -PCL Repair -Extra-capsular repair Medial collateral ligament Lateral collateral ligament Posterior oblique ligament -Patellar realignment and tendon repair Vastus medialis obliquus advancement -Iliotibial band tenodesis Shoulder -Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repair Capsular shift or capsulolabral reconstruction -Acromioclavicular separation repair -Deltoid repair -Rotator cuff tear repair -Biceps tenodesis Foot and Ankle -Hallux valgus repair -Medial or lateral instability repair/reconstruction -Achilles tendon repair/reconstruction -Midfoot reconstruction -Metatarsal ligament/tendon repairs/reconstruction -Bunionectomy -Flexor Hullucis Longus (FLH) -Tendon Transfer Elbow, Wrist, and Hand -Biceps tendon reattachment -Ulnar or radial collateral ligament reconstruction -Lateral epicondylitis repair -Scapholunate ligament reconstruction -Tendon Transfer
-Tendon Transfer
-Carpometacarpal Joint Arthroplasty
FORM FDA 3881 (6/20)
3
| -Carpal Ligament Reconstruction |
|---|
| --------------------------------- |
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."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230874
Device Name Syntheface PEEK Screw Sheath
Indications for Use (Describe)
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
5
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 |
| Primary contact person: | Juan Wu |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: +86-17521559984 | |
| Email: Juan.Wu@microport.com |
Date of preparation: 2023-03-30
II Device
| Trade Name of | Syntheface PEEK Interference Screw, Syntheface PEEK |
|---|---|
| Device: | Screw Sheath |
| Common Name: | Screw, Screw Sheath |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Regulatory Class: | II |
| Product Code: | MBI, HWC |
| Review Panel: | Orthopedic |
| Regulation Number: | 888.3040 |
III Predicate Devices
| Trade Name: | Biosure PK Interference Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification: | Class II, 21 CFR 888.3040 |
| Product Code: | MBI |
| Premarket Notification: | K083635 |
| Manufacturer: | Smith & Nephew Inc., Endoscopy Division |
| Trade Name: | BIOSURE SYNC Tibial Fixation Device |
| Common Name: | Screw, Fixation, Bone |
| Classification: | Class II, 21 CFR 888.3040 |
| Product Code: | HWC, MBI |
6
Premarket Notification: K093943 Manufacturer: Smith & Nephew Inc., Endoscopy Division
IV Device description
All Syntheface PEEK Interference Screws are non-absorbable. All interference screws are offered in a polyetheretherketone (PEEK) material. Syntheface PEEK Interference Screws are provided sterile, for single use only.
The Syntheface PEEK Interference Screws are composed of 6 different configurations ranging from 6mm to 11mm in diameter and 25mm in length.
The Syntheface PEEK Interference Screw can be used alone or be used in conjunction with the Syntheface PEEK Screw Sheath.
The Syntheface PEEK Screw Sheath shall be used in conjunction with the Syntheface PEEK Interference Screw. All Syntheface PEEK Screw Sheaths are non-absorbable, and are intra-tunnel devices used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The Syntheface PEEK Screw Sheath is a polyetheretherketone (PEEK) material implant for use with Syntheface PEEK Interference Screw. Syntheface PEEK Screw Sheaths are provided sterile, for single use only.
| Trade name | Model |
|---|---|
| Syntheface PEEK Interference Screw | MS-2025PS-6 |
| MS-2025PS-7 | |
| MS-2025PS-8 | |
| MS-2025PS-9 | |
| MS-2025PS-10 | |
| MS-2025PS-11 | |
| Syntheface PEEK Screw Sheath | MS2025PW-6 |
| MS2025PW-8 | |
| MS2025PW-10 | |
| MS2025PW-12 |
The models of Syntheface PEEK Interference Screws and Syntheface PEEK Screw Sheath are listed as below:
V Indications for use
The Syntheface PEEK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less are also indicated for use in the following procedures:
Knee
7
-ACL Repair
-PCL Repair
-Extra-capsular repair
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
-Patellar realignment and tendon repair
- Vastus medialis obliquus advancement
-Iliotibial band tenodesis
Shoulder
-Capsular stabilization
- Bankart repair
- · Anterior shoulder instability
- · SLAP lesion repair
- Capsular shift or capsulolabral reconstruction
-Acromioclavicular separation repair
-Deltoid repair
-Rotator cuff tear repair
-Biceps tenodesis
Foot and Ankle
-Hallux valgus repair
-Medial or lateral instability repair/reconstruction
-Achilles tendon repair/reconstruction
-Midfoot reconstruction
-Metatarsal ligament/tendon repairs/reconstruction
-Bunionectomy
- -Flexor Hullucis Longus (FLH)
- -Tendon Transfer
Elbow, Wrist, and Hand
-Biceps tendon reattachment
-Ulnar or radial collateral ligament reconstruction
- -Lateral epicondylitis repair
- -Scapholunate ligament reconstruction
- -Tendon Transfer
- -Carpometacarpal Joint Arthroplasty
- -Carpal Ligament Reconstruction
The Syntheface PEEK Screw Sheath is indicated for use in combination with Syntheface
8
PEEK Interference Screw for fixation of soft tissue to bone during cruciate ligament reconstruction.
VI Comparison of technological characteristics with the predicate devices
Syntheface PEEK Interference Screws and Syntheface PEEK Screw Sheaths 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
(Syntheface PEEK
Interference Screw) | Predicate Device
K083635, Biosure PK
Interference Screw | 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. |
| Indications for
use | The Syntheface PEEK
Interference Screw is
indicated for the
reattachment of
ligament, tendon, soft
tissue, or bone to bone
during cruciate ligament
reconstruction surgeries
of the knee. All screws
with a diameter of 9mm
or less are also indicated
for use in the following
procedures:
Knee
-ACL Repair
-PCL Repair
-Extra-capsular repair
- Medial collateral
ligament | The Smith & Nephew
BIOSURE PK
Interference Screws are
indicated for the
reattachment of ligament,
tendon, soft tissue, or
bone to bone during
cruciate ligament
reconstruction surgeries
of the knee. All screws
with a diameter of 9mm or
less are also intended for
use in the following
procedures:
Knee
-ACL Repairs
-PCL Repairs
-Extra-capsular repairs - Medial collateral | Identical as
predicate
device. |
Table 5.1 Substantial equivalence discussion -Syntheface PEEK Interference Screw
9
| • Lateral collateral
ligament
• Posterior oblique
ligament
-Patellar realignment
and tendon repair
• Vastus medialis
obliquus advancement
-Iliotibial band tenodesis
Shoulder
-Capsular stabilization
• Bankart repair
• Anterior shoulder
instability
• SLAP lesion repair
• Capsular shift or
capsulolabral
reconstruction
-Acromioclavicular
separation repair
-Deltoid repair
-Rotator cuff tear repair
-Biceps tenodesis
Foot and Ankle
-Hallux valgus repair
-Medial or lateral
instability
repair/reconstruction
-Achilles tendon
repair/reconstruction
-Midfoot reconstruction
-Metatarsal
ligament/tendon
repairs/reconstruction
-Bunionectomy
-Flexor Hullucis Longus
(FLH) | ligament
• Lateral collateral
ligament
• Posterior oblique
ligament
-Patellar realignment and
tendon repairs
• Vastus medialis
obliquous advancement
-Iliotibial band tenodesis
Shoulder
-Capsular stabilization
• Bankart repair
• Anterior shoulder
instability
• SLAP lesion repairs
• Capsular shift or
capsulolabral
reconstructions
-Acromioclavicular
separation repairs
-Deltoid repairs
-Rotator cuff tear repairs
-Biceps tenodesis
Foot and Ankle
-Hallux valgus repairs
-Medial or lateral
instability
repairs/reconstructions
-Achilles tendon
repairs/reconstructions
-Midfoot reconstructions
-Metatarsal
ligament/tendon
repairs/reconstructions
-Bunionectomy
-Flexor Hullucis Longus
(FLH) |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
10
| -Tendon Transfers | |||
|---|---|---|---|
| Elbow, Wrist, and | |||
| Hand | Elbow, Wrist, and Hand | ||
| -Biceps tendon | |||
| reattachment | -Biceps tendon | ||
| reattachment | |||
| -Ulnar or radial collateral | |||
| ligament reconstruction | -Ulnar or radial collateral | ||
| ligament reconstructions | |||
| -Lateral epicondylitis | |||
| repair | -Lateral epicondylitis | ||
| repair | |||
| -Scapholunate ligament | |||
| reconstruction | -Scapholunate ligament | ||
| reconstruction | |||
| -Tendon Transfer | -Tendon Transfers | ||
| -Carpometacarpal Joint | |||
| Arthroplasty | -Carpometacarpal Joint | ||
| Arthroplasty | |||
| -Carpal Ligament | |||
| Reconstruction | -Carpal Ligament | ||
| Reconstruction | |||
| Picture | Similar as | ||
| predicate | |||
| device. | |||
| Composition | Interference Screw | Interference Screw | Identical as |
| predicate | |||
| device. | |||
| Patient | |||
| Contacting | |||
| Material | PEEK 100% (Optima | ||
| PEEK) | PEEK 100% (Optima | ||
| PEEK) | Identical as | ||
| predicate | |||
| device. | |||
| Dimensional | |||
| Verification | Interference screw | ||
| diameter: 6mm, 7mm, | |||
| 8mm, 9mm, 10mm, | |||
| 11mm | |||
| Interference screw | |||
| length: 25mm | Interference screw | ||
| diameter: 6mm, 7mm, | |||
| 8mm, 9mm, 10mm, | |||
| 11mm | |||
| Interference screw | |||
| length: 25mm | Substantially | ||
| equivalent. | |||
| Sterilization | EO sterilization | Irradiation sterilization | Different, but |
| subject | |||
| device has a | |||
| SAL of 10-6 | |||
| and EO | |||
| sterilization | |||
| Shelf-life | 5 Years | 5 Years | method had |
| been | |||
| validated. | |||
| Identical as | |||
| predicate | |||
| device. | |||
| Single | |||
| Use/Reuse | Single Use | Single Use | Identical as |
| predicate | |||
| device. | |||
| Operating | |||
| Principle | The Syntheface PEEK | ||
| Interference Screw is a | |||
| fixation screw that fixes | |||
| soft tissue such as | |||
| ligaments, tendons, and | |||
| the articular capsules to | |||
| bone, and is used in | |||
| orthopedic surgery. | The Biosure PK | ||
| Interference Screw is a | |||
| fixation screw that fixes | |||
| soft tissue such as | |||
| ligaments, tendons, and | |||
| the articular capsules to | |||
| bone, and is used in | |||
| orthopedic surgery. | Identical as | ||
| predicate | |||
| device. | |||
| Environment of | |||
| Use | Hospitals/clinics | Hospitals/clinics | Identical as |
| predicate | |||
| device. |
11
| Characteristics | Subject
(Syntheface
Screw Sheath) | Device
PEEK | Predicate Device
K093943, Biosure SYNC
Tibial Fixation Device | Remarks | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------|
| Product Code | HWC, MBI | | HWC, 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 Syntheface PEEK
Screw Sheath is
indicated for use in
combination with
Syntheface PEEK
Interference Screw for | | The Smith & Nephew
BIOSURE SYNC Tibial
Fixation Device is
indicated for use in
combination with
BIOSURE PK Screws for | Identical as
predicate
device. | |
| | fixation of soft tissue to
bone during cruciate
ligament reconstruction. | fixation of soft tissue to
bone during cruciate
ligament reconstruction. | | | |
| Picture | Image: [screw sheath] | Image: [screw sheath] | Similar as
predicate
device. | | |
| Composition | Screw Sheath | Screw Sheath | Identical as
predicate
device. | | |
| Patient
Contacting
Material | PEEK 100% (Optima
PEEK) | PEEK 100% (Optima
PEEK) | Identical as
predicate
device. | | |
| Dimensional
Verification | Screw Sheath width:
9mm, 10.5mm, 12.6mm,
14.6mm;
Screw Sheath height:
10.5mm, 12.2mm,
14.7mm, 17.8mm;
Screw Sheath length:
34mm | BIOSURE SYNC Device
width: 9.6mm, 11.1mm,
13.3mm, 15.3mm;
BIOSURE SYNC Device
height: 11mm, 12.5mm,
15.3mm, 18.3mm;
BIOSURE SYNC Device
length: 34mm | Substantially
equivalent,
and
performance
bench tests
had been
conducted to
support the
substantial
equivalence. | | |
| Compatible
screw size | Interference
screw (X
mm × 25
mm) | Screw
sheath
(mm) | BIOSURE
PK screw
(X mm ×
25 mm) | BIOSURE
SYNC
Device
(mm) | Similar as
predicate
device. |
| | 6 | 6 | 6 | 5-6 | |
| | 7 | 8 | 7 | 7-8 | |
| | 8 | 8 | 8 | 7-8 | |
| | 9 | 10 | 9 | 9-10 | |
| | 10 | 10 | 10 | 9-10 | |
| | 11 | 12 | 11 | 11-12 | |
| Sterilization | EO sterilization | Irradiation sterilization | | | Different, but
subject
device has a |
12
13
| | | | SAL of 10-6
and EO
sterilization
method had
been
validated. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Shelf-life | 5 Years | 5 Years | Identical as predicate device. |
| Single Use/Reuse | Single Use | Single Use | Identical as predicate device. |
| Operation principle | Insert the screw sheath into the tibial tunnel. The sheath separates the graft strands and places them against the tunnel wall. Then the screw will be inserted into the center of the screw sheath to achieve the fixation of soft tissue to bone during cruciate ligament reconstruction | Insert the screw sheath into the tibial tunnel. The sheath separates the graft strands and places them against the tunnel wall. Then the screw will be inserted into the center of the screw sheath to achieve the fixation of soft tissue to bone during cruciate ligament reconstruction | Identical as predicate device. |
| Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. |
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 surgical implants.
We have complied with the following material standards:
ASTM F2026-17: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Biocompatibility testing
14
Biocompatibility of the Syntheface PEEK Interference Screw and Syntheface PEEK Screw Sheath were 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)".
Bacterial endotoxin testing
Bacterial endotoxins for the interference screw and screw sheath are determined using LAL testing to meet endotoxin limit specifications.
Mechanical performance testing
The following are the mechanical tests that have been performed on the Subject device and Predicate device:
-
- Screw-in test
-
- Pullout test
-
- Fatigue test
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 Syntheface PEEK Interference Screw and Syntheface PEEK Screw Sheath are MR safe as the polyetheretherketone material is nonmetallic, nonconducting materials that do not contain ferromagnetic materials or any other metallic markers that can interfere with magnetic resonance imaging (MRI). There are no concerns with the performance of the devices in an MRI environment. These devices are labeled MR safe per ASTM F2503.
VIII Conclusion
The Syntheface PEEK Interference Screw and Syntheface PEEK Screw Sheath are substantially equivalent to the predicate devices. The non-clinical testing demonstrates that the devices are as safe, as effective and performs as well as the legally marketed devices.