(322 days)
No
The document describes a mechanical device (a screw) and its physical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the fixation of ligaments and tendons in patients requiring ligament or tendon repair, which directly addresses a medical condition or injury.
No
This device is a surgical implant designed for fixation of ligaments and tendons, not for diagnosis. Its purpose is to repair, not to detect or identify a medical condition.
No
The device description explicitly states it is a "cannulated, tapered fastener" made from a "Titanium alloy" and is available in various "sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length." This describes a physical, implantable 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 is "in the fixation of ligaments and tendons in patients requiring ligament or tendon repair." This describes a surgical implant used directly within the body for structural support.
- Device Description: The description details a "cannulated, tapered fastener" made of titanium alloy, designed for "Interference fixation of ligaments and tendons." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Auxilock Titanium Interference Screw does not involve any such testing or analysis of biological samples.
The device is clearly a surgical implant used for musculoskeletal repair, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Auxilock Titanium Interference Screw is in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Product codes
HWC, MBI
Device Description
Auxein Brand Auxilock titanium Interference screw is cannulated, tapered fastener for use in Interference fixation of ligaments and tendons in patients requiring ligament or tendon-repair.
The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length.
Each variant of Auxilock Titanium Interference Screw are sold both in non-sterile and sterile (EO & Gamma Sterile) conditions.
Non-sterile version of Auxilock Titanium Interference Screw have to be sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ligaments and tendons
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The pull out strength, Torsional Strength, Screw In and Out and Pull Out Based Fatique test were measured for the smallest dia. i.e. 7 mm Auxilock Titanium Interference Screws. The above test were also performed for the samples of Titanium Interference Screw of Parcus Medical and results of these test demonstrated that there were no significant differences between both the devices.
Bacterial endotoxins for the implantable components are determined using LAL testing to meet endotoxin limit specifications.
Biocompatibility testing of the samples has been conducted as per EN ISO 10993-1.
We have performed accelerated and real-time studies as per EN ISO 11607-1:2009.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 20, 2021
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".
Auxein Medical Private Limited Rahul Luthra Director Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial area Sonepat-131028, Haryana India
Re: K203029
Trade/Device Name: Auxilock Titanium Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: July 14, 2021 Received: July 20, 2021
Dear Mr. Rahul Luthra:
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 mav, 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
1
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 (OS) 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,
Pooja Panigrahi -S
for
Laura C. Rose, 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
Enclosure
2
Indications for Use
510(k) Number (if known) K203029
Device Name Auxilock Titanium Interference Screw
Indications for Use (Describe)
The Auxilock Titanium Interference Screw is in the fixation of ligaments and tendons in patients requiring ligament or tendon 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) |
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3
510(k) Number: K203029 Dated: August 21, 2021
7-A. Nirankari Colony
Delhi-110009, Indian
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV
Sector-57, Kunda industrial Area
C. Sonepat-131028, Moryana, india
Page 1 of 5
+91 9910643658
6077 70197 (FAX)
Section 5.0: 510K Summary
Premarket Notification 510(k) Summary as required by Section 807.92 General Company Information as required by 807:92(a) (A.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared.
| Submitter's Name: | Auxein Medical Private Limited |
|---|---|
| Address: | Auxein Medical Pvt. Ltd. |
| Plot No. 168-169-170, Phase- IV, Kundli Industrial Area, HSIIDC, | |
| Sector-57, Sonepat-131028, Haryana. | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 21/08/2021 |
Throughout the submission Auxilock Titanium Interference Screw is covered under 510(k) Submission.
(A.2) The name of the device, including the trade or proprietary name if applicable, thecommon or usual name, and the classification name, if known
Proprietary Name:
Auxilock Titanium Interference Screw
Common or Usual Name:
Interference Screws
Classification Name:
Fastener, Fixation, Non-Degradable, Soft tissue.
Product Code:
HWC, MBI
Device Class: II
Review Panel: Orthopaedic
Regulation Number: 21 CFR 888.3040
4
Image /page/4/Picture/0 description: The image contains the logo for Auxein. The logo consists of a stylized letter "A" enclosed in a circle, followed by the text "Auxein" in a bold, sans-serif font. The color of the logo and text is a shade of blue.
Delhi-110009, Ind
MANUFACTURING UNI
Plot No. 169-170, Phase-
Sector 57, Kunda industrial Are
OC, Sonepat-131028, Haryana, irid
Image /page/4/Picture/2 description: The image shows the text 'K203029 Page 2 of 5'. The text is black and is set against a white background. The text is likely part of a document or report, indicating a page number and potentially a document identifier.
.auxein.com
Variants/Types:
An Auxilock titanium Interference screw is a cannulated, tapered fastener for use in Interference fixation of ligaments and tendons in patients requiring ligament or tendonrepair.
The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length.
(A.3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
The following is the range of variants covered with their corresponding predicate devices.
| S.No. | Item Description | Predicate Device |
|---|---|---|
| 1. | Auxilock Titanium Interference Screw | K083619, Parcus Titanium Interference |
| Screw |
Reference Device: K201457, Auxien Brand Vertaux 5.5 mm Pedicle Screw System
(A.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labelling or promotional material for the device.
Device Description:
Auxein Brand Auxilock titanium Interference screw is cannulated, tapered fastener for use in Interference fixation of ligaments and tendons in patients requiring ligament or tendon-repair.
The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length.
Each variant of Auxilock Titanium Interference Screw are sold both in non-sterile and sterile (EO & Gamma Sterile) conditions.
Non-sterile version of Auxilock Titanium Interference Screw have to be sterilized before use.
(A.5) A statement of the intended use of the device.
Indications for Use:
Auxilock Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
(A.6). Summary of Technological Characteristics as compared to the predicate devices:
5
Image /page/5/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle, followed by the word "Auxein" in a sans-serif font. The logo is blue in color.
Delhi-110 009, Indi
MANUFACTURING UNI
Plot No. 169-170, Phase-IV
Sector-57. Kunda industrial Area
DC, Sonepat-131028, PHaryana, indu
UNIT
-IV,
Area,
India
Page 3 of 5
.auxein.com
Substantial equivalence including comparison with predicate devices.
A comparison between the Auxilock Titanium Interference screw and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
Following is the summary of parameters in which the comparison has been verified:
| S.No. | Characteristics | Predicate Device Versus New
Device(Auxein Brand) | Remarks |
|-------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 1. | Indications for use | Similar intended use in New Device and
Predicate device. | Equivalent |
| 2. | Material | Conform to same material standard. | Equivalent |
| 3. | Performance Standards | Same performance standards used in
both New Device as well as predicate
device. | Equivalent |
| 4. | Sterilization | Predicate device is supplied in Non-sterile
and EO sterile but our device will be
supplied in Non-Sterile, Gamma Sterile
and EO Sterile. | Equivalent |
| 5. | Dimensional Verification | Same dimensions found in both New
Device as well as Predicate device. | Equivalent |
(B.1). Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards: A:
Material Standards
B: Performance Standards
A: 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.
-
ASTM F 136: Standard specification for wrought Titanium - 6Aluminum - 4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
-
ASTM F 899-12: Standard Specification for Wrought Stainless Steels for surgical instruments.
We have verified the purchased material compliance to these standards and copies of the relevant test results are attached herewith.
6
Image /page/6/Picture/0 description: The image contains the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle on the left, followed by the word "Auxein" in a sans-serif font. The color of the logo is blue.
Delhi-110 009, Ind
MANUFACTURING UN
Plot No. 169-170, Phase-I
Sector-57. Kundli Industrial Are
DC, Sonepat-131028, Haryana, Ind
1 86077 703197 (FAX)
www.auxein.com
B: Performance Standards:
The device performance of Auxilock Titanium Interference Screw system has been demonstrated against following applicable standards.
- . ASTM F 543-17
- Custom Fatigue Testing ●
(B.1). Summary of performance testing:
The pull out strength, Torsional Strength, Screw In and Out and Pull Out Based Fatique test were measured for the smallest dia. i.e. 7 mm Auxilock Titanium Interference Screws. The above test were also performed for the samples of Titanium Interference Screw of Parcus Medical and results of these test demonstrated that there were no significant differences between both the devices.
Bacterial endotoxins for the implantable components are determined using LAL testing to meet endotoxin limit specifications.
Biocompatibility testing of the samples has been conducted as per EN ISO 10993-1.
We have performed accelerated and real-time studies as per EN ISO 11607-1:2009.
Reference device for shelf-life and packaging is already approved by USFDA (K201457) and the scoped device (Auxilock Titanium Interference Screw) contains same packaging material as that of K201457.
Conclusion:
General, Safety and Performance conclusion:
| S.No. | Parameter of
Conclusion | Proposed Device | Predicate Device |
|-------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| 1. | Product Code | MBI, HWC | Same |
| 2. | Regulation Number | 21 CFR 888.3040. | Same |
| 3. | Regulatory Class | Class II | Same |
| 4. | Intended Use | The Auxilock Titanium Interference
Screw is indicated for use in the fixation
of ligaments and tendons in patients
requiring ligament or tendon repair. | Similar Intended
Use |
| 5. | Sterilization | Same method of sterilization used in
both New Device as well as Predicate
device. | Same |
| 6. | Mechanical Test
Performance | Pull out strength, Torsional Strength,
Screw In and Out and Pull Out Based
Fatigue test. | Same |
7
Image /page/7/Picture/0 description: The image shows the word "Auxein" in blue font. To the left of the word is a blue logo that appears to be the letter "A" inside of a circle. The logo and the word are the only elements in the image. The background is white.
Image /page/7/Picture/1 description: The image shows contact information for a company. The corporate office is located at 7-A Nirankari Colony, Delhi-110 009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector 57, Kundli Industrial Area, HSIIDC, Sonepat-131028, Haryana, India. The phone number is +91 99106 43618 and the fax number is +91 86077 70197. The website is www.auxein.com.
| 7. | Material Standards | ASTM F 136 & ASTM F 899-12b. | Same |
|---|---|---|---|
| ----------- | -------------------- | ------------------------------ | ------ |
From the data available we can justify that the Auxilock Titanium Interference screw is as safe, and as effective and performs as same indications for use as that of already marketed predicate devices identified in A.3. of 510(k) summary.