Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:

3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.

3.5mm Wise-Lock Proximal Tibia Plate:

3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Proximal Tibia Plate:

The 3.5mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.

3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extraarticular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab: The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Lateral Distal Fibula Plate:

The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:

The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Pilon Plate:

The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Pilon Plate, Cruciform:

3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Z-type Distal Medial Tibial Plate: The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation of osteotomies and fractures, including: Comminuted fractures Supracondylar fractures Intra-articular and extra-articular condylar fractures Non-unions, and

Malunions

3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:

The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:

Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and fractures with associated shaft fractures.

To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.

The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:

The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:

The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated deplit or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomies.

4.5/5.0mm Wise-Lock Proximal Tibia Plate:

4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

AV-Wise Lock Ankle System

The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:

Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, nonunions, nalunions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia,

Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and

Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

AV-Wise Lock Proximal Tibia Plates

The AV-Wise Lock Proximal Tibia Plates are indicated to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies.

Device Description

The Tibia and Fibula System consists of three types of bone Plates system i.e. Wise-Lock Tibia & Fibula Plates, AV-Wise Lock Ankle Plates, AV-Wise Lock Proximal Tibia Plate and screws for implantation in the tibia and fibula bone to treat tibia and fibula bone fractures. The bone plates are available in Stainless steel and Titanium material and also in left and right directional configuration. There are 16 types of bone plates in Wise-lock tibia and fibula bone plates in AV-Wise Lock Ankle bone plates and 2 bone plates in AV-Wise Lock Proximal Tibia bone plate system. There are 25 types of bone screws associated with these bone plates.

These implants are sold in both non-sterile and sterile conditions.

Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device called the "Tibia and Fibula System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information required for your request (acceptance criteria and detailed study information) is typically not extensively detailed in a 510(k) summary, as the primary goal is to show equivalence.

However, based on the provided text, I can extract the following information concerning the acceptance criteria and the types of studies performed to show equivalence, rather than a detailed performance study proving efficacy against acceptance criteria. The document states that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and performs as safely and effectively.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the material and performance standards the device claims to meet, and the "reported device performance" is the statement that the device conforms to these standards and exhibits equivalent performance to the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Product Code: HWC (Primary), HRS	Identical as predicate device
Regulation Number: 21 CFR 888.3030 (Primary), 21 CFR 888.3040	Identical as predicate device
Regulatory Class: Class II	Identical as predicate device
Indications for Use: Fracture treatment of Tibia and fibula bone	Identical as predicate device
Material: Titanium Alloy as per ASTM F136 and Stainless Steel as per ASTM F138.	Conform to the same material standard as predicate device (specifically, SS 304 for instruments per ASTM F899-20, SS 316L for Stainless Steel Implants, and Ti-6Al-4V Grade 5 for Titanium Implants per ASTM F136/ISO 5832-3, ASTM F138/ISO 5832-1)
Performance Standards: ASTM F382 and F543	Identical as predicate device. Bench tests conducted to verify all design specifications and compliance with ASTM F382 (Metallic Bone Plates, including Four-Point Static Test and Four-Point Fatigue Test - Conforms) and ASTM F543 (Metallic Medical Bone Screws, including Driving Torque Test, Torsion Test, Axial Pull-out Test - Conforms). The results indicate the system is equivalent to a predicate device.
Sterilization: Gamma Sterilization Method and Non-Sterile	Identical as predicate device. Compliance with ISO 11137-1, -2, -3; ISO 17665-1, -2, -3; ISO 11140-1; ISO 11737-1, -2; ISO 11607-1, -2; ASTM F1980; ASTM F88/F88M; ASTM F1929.
Shelf-life: 5 Years (For Sterilized Product)	Identical as predicate device. Stability study performed to determine shelf life, following ASTM F1980, ASTM F88/F88M, and ASTM F1929.
Single Use/Reuse: Single Use	Identical as predicate device
Operating Principle: Plate fixed to bone by screws	Identical as predicate device
Dimensional Verification: Same dimensions as predicate devices	Identical as predicate device
Biocompatibility: Evaluated for biocompatibility according to ISO 10993-3	Conforms
Bacterial Endotoxin: Endotoxin testing limit ≤ 20 EU/Device	Conforms. Limulus Amoebocyte Lysate (LAL) test performed. Test performed according to standard USP 32 chapter 85, USP <85> Bacterial Endotoxin Test, and USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical studies with patients or data. The testing mentioned is bench testing on the physical devices (plates and screws). Therefore, the concept of data provenance (country, retrospective/prospective) and sample size in the traditional sense of medical image analysis or clinical trials is not applicable here. The "sample" would refer to the number of devices tested in the lab, which is not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this 510(k) summary. The ground truth in this context is defined by international and national standards for material properties and mechanical performance, not by expert medical assessment of cases.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human adjudication of a test set in the methods described. The "adjudication" of performance is done by comparing test results against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing for mechanical properties and material equivalence, not human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (bone plate and screw system), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established engineering standards (e.g., ASTM F382, ASTM F543, material standards like ASTM F136, ASTM F138, ASTM F899) and biological safety standards (e.g., ISO 10993-3 for biocompatibility, USP <85> for bacterial endotoxin). This is a technical ground truth, not a clinical one derived from pathology or outcomes data in patients.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this device is a physical implant, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, there is no training set for this type of device.

Summary

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January 27, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Auxein Medical Private Limited Rahul Luthra Director Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, Haryana 131028 India

Re: K213059

Trade/Device Name: Tibia and Fibula System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 5, 2022 Received: May 11, 2022

Dear 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 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

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restoritive, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213059

Device Name Tibia and Fibula System

Indications for Use (Describe) Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixations for the plates included in the system as follows:

3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia.

3.5mm Wise-Lock Proximal Tibia Plate:

3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Proximal Tibia Plate:

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:

3.5mm Wise-Lock Anterolateral Distal Tibia Plate: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Lateral Distal Fibula Plate:

The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:

The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Pilon Plate:

The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

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3.5mm Wise-Lock Pilon Plate, Cruciform:

3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

Malunions

3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:

The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:

4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:

4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:

4.5/5.0mm Wise-Lock Proximal Tibia Plate:

AV-Wise Lock Ankle System

Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fragments of the distal tibia, and

Lateral Distal Fibula Plates are indicated for fixation of osteotomies, malunions, malunions, and replantations of FORM FDA 3881 (6/20) Page 2 of 3

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AV-Wise Lock Proximal Tibia Plates

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)

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Image /page/5/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it, followed by the word "Auxein" in blue. There is a small circle above the "i" in "Auxein".

510k Summary

Pre Market Notification 510(k) Summary as required by section 807.92 General Company Information as required by 807.92 (a)

Submitter's Name:	Auxein Medical Private Limited
Address:	Auxein Medical Private Limited
	Plot No. 168-169-170, Phase-4, Kundli Industrial Area, HSIIDC,
	Sector-57, Sonepat-131028, Haryana, India
Contact Person Name:	Mr. Rahul Luthra
Title:	Director
Phone Number:	+91-9560557733
Email Id:	info@auxein.com
Dated:	27.01.2023

Person Responsible for Regulatory Compliance

Name:	Mr. Mohit Kumar
Title:	Sr. Research Engineer
Email Id:	m.kumar@auxein.com
Dated:	27.01.2023

Proprietary Name:

Tibia and Fibula System

Common or Usual Name:

Plate, Fixation, Bone (Primary) Screw Fixation, Bone

Classification Name:

Single/multiple component metallic bone fixation appliances and accessories (Primary) Smooth or threaded metallic bone fixation fastener

Product Code:

HRS (Primary) HWC

Device Class: II

Review Panel: Orthopedic

Regulation Number:

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21 CFR 888.3030 (Primary)

21 CFR 888.3040

Primary ProductCode	Classification Name	Common Name	Regulation Number
HRS	Single/multiple component metallic bone fixation appliances and accessories	Plate, Fixation, Bone	21 CFR 888.3030

Variants/Types:

Tibia and Fibula Systems consist of the following Components:

S.No.	Item Description
Wise-Lock Tibia & Fibula System Plates
1.	3.5mm Wise-Lock Medial Distal Tibia Plate, (4, 6, 8, 10, 12, 14 Holes), Left and Right
2.	3.5mm Wise-Lock Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left and Right
3.	3.5mm Wise-Lock Medial Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16, 18, 20 Holes), Leftand Right
4.	3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate, (1, 2, 4, 6, 8, 10 Holes)
5.	3.5mm Wise-Lock Anterolateral Distal Tibia Plate, (5, 7, 9, 11, 13, 15, 17, 19, 21 Holes),Left and Right
6.	3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab, (4, 6, 8, 10, 12, 14 Holes), Leftand Right
7.	3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab, (4, 6, 8, 10, 12, 14Holes), Left and Right
8.	3.5mm Wise-Lock Lateral Distal Fibula Plate, (3, 4, 5, 6, 7, 9, 11 Holes), Left and Right
9.	3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia, (4, 5, 6, 7, 8, 9, 10, 12, 14,16, 18, 20 Holes), Left and Right
10.	3.5mm Wise-Lock Pilon Plate, (7, 9 Holes)
11.	3.5mm Wise-Lock Pilon Plate, Cruciform, (7, 9 Holes)
12.	3.5mm Wise-Lock Z-type Distal Medial Tibial Plate, (6, 8, 10, 14, 18 Holes), Left andRight
13.	3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate, (6, 8, 10, 12, 14, 16 Holes), Leftand Right
14.	4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate, (5, 7, 9, 11, 13 Holes), Left and Right
15.	4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left andRight
16.	4.5/5.0mm Wise-Lock Proximal Tibia Plate, (4, 6, 8, 10, 12, 14, Holes), Left and Right
AV-Wise Lock Ankle System Plates
17.	2.7/3.5mm AV-Wise Lock Anteromedial Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes)
18.	2.7/3.5mm AV-Wise Lock Medial Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16 Holes), Left & Right
19.	2.7mm AV-Wise Lock Distal Tibia L-Plate, (4, 6 Holes), Left & Right
20.	2.7mm AV-Wise Lock Distal Tibia T-Plate, (4, 6 Holes)
21.	2.7mm AV-Wise Lock Lateral Distal Fibula Plate, (3, 4, 5, 6, 7, 9, 11, 13, 15 Holes), Left & Right
22.	2.7/3.5mm AV-Wise Lock Anterolateral Distal Tibia Plate, (4, 6, 8, 10, 12, 14, 16, 18 Holes), Left & Right
23.	3.5mm AV-Wise Lock Proximal Tibia Plate, Small Bend, (4, 6, 8, 10, 12, 14 Holes), Left & Right
24.	3.5mm AV-Wise Lock Proximal Tibia Plate, Large Bend, (4, 6, 8, 10, 12, 14 Holes), Left & Right
	Screws
25.	2.7mm Wise-Lock Screw, Self-Tapping (Hex Head), (10-60 mm) Length
26.	3.5mm Wise-Lock Screw, Self-Tapping (Hex Head), (10-80 mm) Length
27.	3.5mm Wise-Lock Screw, Self-Drilling, (Hex Head), (10-60 mm) Length
28.	3.5mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head), (10-60 mm) Length
29.	3.5mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head), (10-60 mm) Length
30.	3.5mm Cortical Screw, Self-Tapping, (Hex Head), (10-90 mm) Length
31.	4.0mm Cancellous Screw, Short Thread, (12-60 mm) Length
32.	4.0mm Cancellous Screw, Full Thread, (12-60 mm) Length
33.	4.5mm Cortical Screw, Self-Tapping, (Hex Head), (12-60 mm) Length
34.	5.0mm Wise-Lock Screw, Self-Tapping, (Hex Head), (12-90 mm) Length
35.	5.0mm Wise-Lock Screw, Self-Tapping & Self-Drilling, (Hex Head), (12-90 mm) Length
36.	5.0mm Wise-Lock Cancellous Screw, Full Thread, Self-Tapping, (Hex Head), (20-110 mm) Length
37.	5.0mm Wise-Lock Cancellous Screw, Short Thread, Self-Tapping, (Hex Head), (20-110 mm) Length
38.	5.0mm Wise-Lock Cannulated Screw, Full Thread, Self-Tapping, (20-120 mm) Length
39.	5.0mm Wise-Lock Cannulated Screw, Partial Thread, Self-Tapping, (30-100 mm) Length
40.	6.5mm Cancellous Screw, 16mm Thread, (25-120 mm) Length
41.	6.5mm Cancellous Screw, 32mm Thread, (35-120 mm) Length
42.	6.5mm Cancellous Screw, Full Thread, (35-120 mm) Length
43.	2.7mm Cortical Screw, Self-Tapping, (Hex Head), Titanium, (6-30 mm) Length
44.	2.7mm AV-Wise Lock Screw, Self-Tapping, (Star Head), (6-70mm) Length
45.	2.7mm Cortical Screw, Self-Tapping, (Star Head), (6-70mm) Length
46.	2.7mm Wise-Lock Screw, Self-Tapping, (Star Head), (6-70mm) Length
47.	3.5mm AV-Wise Lock Screw, Self-Tapping, (10-95mm) Length
48.	3.5mm Cortical Screw, Self-Tapping, (Star Head), (10-90mm) Length
49.	3.5mm Wise-Lock Screw, Self-Tapping, (Star Head), (10-95mm) Length

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Image /page/8/Picture/1 description: The image contains the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. A registered trademark symbol is located to the right of the word.

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.

Primary Predicate device:

510K Number	K013248
Applicant	Synthes, USA
Device Name	3.5mm LCP Medial Distal Tibia Plate

Reference Predicate device:

510K Number	K073460
Applicant	Synthes, USA
Device Name	3.5/2.7 mm LCP Distal Fibula Plates

510K Number	K141680
Applicant	Auxein Medical Pvt. Ltd. India
Device Name	Bone Plates

510K Number	K020602
Applicant	Synthes, USA.
Device Name	3.5mm LCP Pilon Plate

510K Number	K111039
Applicant	Zimmer
Device Name	Zimmer Periarticular Locking Plate System

510K Number	K061098
Applicant	Zimmer
Device Name	EBI OptiLock Periarticular Plating System

510K Number	K052390
Applicant	Synthes, USA
Device Name	Synthes LCP Proximal Tibia Plates Line Extension

510K Number	K050646
Applicant	Synthes, USA
Device Name	Synthes (USA) 3.5/4.5mm LCP MedialProximal Tibia Plates

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Image /page/9/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.

510K Number	K030597, K011978
Applicant	Synthes (USA)
Device Name	3.5mm Titanium LCP Proximal Tibia Plate,Stainless Steel LCP Proximal Tibia plate

510K Number	K120854
Applicant	Synthes, USA
Device Name	Synthes VA LCP Ankle Trauma System

510K Number	K120689
Applicant	Synthes, USA
Device Name	Synthes 3.5 mm VA-LCP Proximal Tibia Plate System

510K Number	K050646
Applicant	Synthes,USA
Device Name	Synthes (USA) 3.5/4.5mm LCP MedialProximal Tibia Plates

510K Number	K082624
Applicant	Synthes,USA
Device Name	Synthes (USA) 3.5mm LCP PosteromedialProximal Tibia Plates

510K Number	K120360
Applicant	Ortho Solutions Limited, U.K
Device Name	4.0mm Cancellous Screw, Short thread

Device Description:

These implants are sold in both non-sterile and sterile conditions.

Note- Non sterile products have to be sterilized before use. The system is indicated for use in adult patients only. All implants are for single use only.

Indications for Use

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Wise-Lock Tibia & Fibula System

The Wise-Lock Tibia & Fibula System plates are intended for fracture fixation. Indications for the plates included in the system as follows:

3.5mm Wise-Lock Medial Distal Tibia Plate:

Medial distal tibia plates are indicated for treating fractures of the tibia.

3.5mm Wise-Lock Proximal Tibia Plate:

3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Proximal Tibia Plate:

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:

3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of the proximal, distal, and metaphyseal areas of the tibia.

3.5mm Wise-Lock Anterolateral Distal Tibia Plate:

3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.

3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab:

The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab:

The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Lateral Distal Fibula Plate:

The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and nonunions of the metaphyseal and diaphyseal region of the distal fibula.

3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:

The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula.

3.5mm Wise-Lock Pilon Plate:

The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

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Image /page/11/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter A inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it.

3.5mm Wise-Lock Pilon Plate, Cruciform:

3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.

3.5mm Wise-Lock Z-type Distal Medial Tibial Plate:

The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

Comminuted fractures o
Supracondylar fractures O
O Intra-articular and extra-articular condylar fractures
O Non-unions, and
O Malunions

3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:

The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is indicated for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:

To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.

The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:

The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, malunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:

The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are indicated to buttress metaphyseal fractures of the medial tibia plateau, split type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.

4.5/5.0mm Wise-Lock Proximal Tibia Plate:

4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft

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Image /page/12/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and clean, and the blue color gives it a professional look.

fractures.

AV-Wise Lock Ankle System

Medial and Anteromedial Distal Tibia Plates are indicated for fixation of osteotomies, fractures, o nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
Distal Tibia T Plates and Distal Tibia L Plates are indicated to buttress partial articular fractures O and bone fragments of the distal tibia, and
O Lateral Distal Fibula Plates are indicated for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

AV-Wise Lock Proximal Tibia Plates

Summary of Technological Characteristics as compared to the predicate devices

A comparison between the Auxein's Tibia and Fibula System 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	Auxein Device	Predicate Device	Remarks
1.	ProductCode	HWC (Primary), HRS	HWC (Primary), HRS	Identical aspredicatedevice
2.	RegulationNumber	21 CFR 888.3030(Primary), 21 CFR888.3040	21 CFR 888.3030(Primary), 21 CFR888.3040	Identical aspredicatedevice
3.	RegulatoryClass	Class II	Class II	Identical aspredicatedevice
4.	Indications for use	The bone plates are indicated for use in fracture treatment of Tibia	The bone plates are indicated for use in fracture treatment of Tibia	Identical aspredicatedevice

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		and fibula bone.	and fibula bone.
5.	Material	Titanium Alloy as perASTM F136 and StainlessSteel as per ASTM F138.	Titanium Alloy as perASTM F136 and StainlessSteel as per ASTM F138.	Conform tothe samematerialstandard aspredicatedevice
6.	PerformanceStandards	The performance testingwas done on the subjectdevice as per the standardASTM F382 and F543.	The performance testingwas done on the subjectdevice as per the standardASTM F382 and F543.	Identical aspredicatedevice
7.	Sterilization	Gamma SterilizationMethod and Non-Sterileused in subject device.	Gamma SterilizationMethod and Non-Sterileused in subject device.	Identical aspredicatedevice
8.	Shelf-life	5 Years (For SterilizedProduct)	5 Years (For SterilizedProduct)	Identical aspredicatedevice
9.	SingleUse/Reuse	Single Use	Single Use	Identical aspredicatedevice
10.	OperatingPrinciple	The plate is fixed to thebone by application ofscrews on both sides of thefracture.	The plate is fixed to thebone by application ofscrews on both sides of thefracture.	Identical aspredicatedevice
11.	DimensionalVerification	The same dimensions are found in both new devices aswell as Predicate devices.		Identical aspredicatedevice

Discussion on the non-clinical testing performed

Following are the applicable product standards considered for non-clinical standards:

. Material Standards.
. Biocompatibility Standards
Performance Standards.
Sterilization, shelf-life and packaging for sterile product.
Bacterial Endotoxin.

Non-Clinical Test Summary:

Bench tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards and has substantially equivalent performance as the predicate:

a.Material Standards:

The material standards are the essential part to be complied with first, as it is the basis of

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manufacturing metallic surgical implants.

We have complied with the following material standards:

ASTM F136/ISO 5832-3: Standard specification for wrought Titanium-6 Vanadium ● ELI (Extra low interstitial) Alloy for surgical implant applications.
ASTM F899-20: Standard Specification for Wrought Stainless Steels for surgical instruments.
ASTM F138/ISO 5832-1: Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants.

Note: We have used Grade 304 of Stainless steel (SS 304) Material for instruments as per ASTM F899-20, Stainless Steel (Grade 316L) for Stainless Steel Implants and Titanium Alloy (Ti-6Al-4V) Grade 5 for Titanium Implants.

We have verified the purchased material and are in compliance to these standards and copies of the relevant test results are attached in Vol 005 Appendix D Implant Material Report and Vol 006 Appendix E ASTM F899 Report of the technical dossier.

b. Performance Standards:

The device performance of Auxein's Tibia and Fibula System has been demonstrated against the following applicable standards:

· ASTM F543-17
ASTM F382-17

Summary of Biocompatibility

The device in its final, finished form has been evaluated for biocompatibility according to ISO 10993-3.

Conclusion of Performance bench testing:

ASTM F382, Standard Specification and Test Method for Metallic Bone Plates. ●
ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws. ●

The following tests were performed with the predicate device:

Plate

Four-Point Static Test: Conforms ●
Four-Point Fatigue Test: Conforms

Screw

Driving Torque Test: Conforms
Torsion Test: Conforms
Axial Pull-out Test: Conforms

The results of this testing indicate that the Tibia and Fibula System is equivalent to a predicate device.

Sterilization, shelf-life and packaging for sterile product

· ISO 11137-1:2006, sterilization of health care products Radiation Part 1: Requirements for

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development, validation and routine control of a sterilization process for medical devices.

. ISO 11137-2:2012, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO/TS 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
. ISO/TS 17665-3:2013(en), Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.
ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General requirements.
ISO 11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of population of microorganisms on products.
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process.
ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system.
ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

Bacterial Endotoxin

Bacterial Endotoxin test was performed on bone plates System by using Limulus Amoebocyte Lysate (LAL) test. The Endotoxin testing limit was less or equal to 20EU/Device. The test was performed according to standard USP 32 chapter 85.

USP <85> Bacterial Endotoxin Test. .
. USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests.

Shelf Life

The stability study has been done to determine the shelf life.

We have followed the below standards for performing shelf-life of the device:

. ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

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Image /page/16/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.

Conclusion:

There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, and operational principles as internal fixation components. From the data available we can justify that the Auxein's Tibia and Fibula System is as safe, and as effective and performs the same indications for use as that of already marketed predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.