AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone plates and bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric fractures. The system is indicated for use in adult patients only. All implants are for single use only.

AUXEIN brand of Locking Plates and Locking screws have the same indications for use as mentioned above with additional feature of locking by way of combination threads in plates and corresponding Screws.

Device Description

Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking screws system consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws,

The plates and screws are fabricated from stainless steel and titanium.

The system contains several modules based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available: like, Reconstruction Plates, , T- Plates, , Anatomical Plates, Clavicle Hook Plates.

These all are mainly divided into

. Mini Fragment Plates
. Small Fragment Plates
Large Fragment Plates .
DCS Plates. ●

The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.

The screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm

These implants are sold non-sterile, the products have to be sterilized prior to use.

AI/ML Overview

This is a 510(k) premarket notification for bone plates and bone screws, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting de novo clinical trials to prove safety and effectiveness.

Therefore, the study supporting this submission is primarily a non-clinical bench testing study comparing the performance of the applicant's device to established standards and predicate devices.

Here's the breakdown of the acceptance criteria and study information as derived from the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" for each test but rather indicates "Conforms" to referenced ASTM standards. The reported device performance is that it conforms to these standards.

Acceptance Criteria (Referenced Standard)	Reported Device Performance
Material Standards:
ASTM F 136	Conforms
ASTM F 138	Conforms
ASTM F 139	Conforms
Performance Standards (Bone Plates):
ASTM F 382 (Static Four Point Bend Test)	Conforms
ASTM F 384 (Dynamic Four Point Bend Test)	Conforms
Performance Standards (Bone Screws):
ASTM F 543 (Torsional Properties)	Conforms
ASTM F 543 (Driving Torque)	Conforms
ASTM F 543 (Pull-out Test)	Conforms

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For bench testing, sample sizes are typically determined by the testing standards (e.g., number of units tested for each standard). The document mentions "copies of the relevant test results were provided in the submission," implying multiple units were tested for each material and performance standard.
- Data Provenance: The testing was conducted by Auxein Medical to demonstrate compliance with ASTM standards. Since the submitter is based in India, the testing likely occurred in India or through a contracted lab. The document does not specify the country of origin for the data acquisition, but it is a prospective test conducted specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical bench testing study. The "ground truth" and "experts" in the context of clinical trials (e.g., radiologists) are not applicable here. The "ground truth" is established by the specified ASTM material and performance standards themselves. The experts involved would be engineers and quality control personnel responsible for conducting the tests and verifying compliance. Their qualifications would be in engineering, materials science, and quality assurance.
Adjudication method for the test set:
- Not applicable in the sense of clinical adjudication. The results of the mechanical tests are compared directly against the quantitative requirements outlined in the ASTM standards. Compliance ("Conforms") is determined by whether the test results fall within the specified limits of the standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This is a medical device for bone fixation, not an image analysis or AI-driven diagnostic device. Therefore, this type of study is not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical bone plate and screw system, not a software algorithm.
The type of ground truth used:
- The "ground truth" for this submission is adherence to established industry material and performance standards (ASTM standards). The claim of substantial equivalence is based on demonstrating that the device meets these standards, which are recognized for orthopedic implants, and is comparable to predicate devices that also meet these standards.
The sample size for the training set:
- This is a non-clinical bench testing study. The concept of a "training set" is not applicable, as there is no machine learning or AI model being developed or trained.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the overall submission is established by the well-defined, published ASTM standards for orthopedic implants.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Auxien Medical Rahul Luthra Director 103, First Floor Jyoti Bhawan Commercial Complex Mukherjee Nagar New Delhi, India 110009

Re: K141680

Trade/Device Name: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws 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 15, 2015 Received: May 21, 2015

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 may, therefore, market the device, subject to the general controls provisions of the Act. 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

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Page 2 - Mr. Rahul Luthra

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141680

Device Name

AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws

Indications for Use (Describe)

AUXEIN Brand of Bone plates and bone screws are provided non-sterile.

AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws.

AUXEIN Brand of Bone plates and bone screws are provided non-sterile. AUXEIN Brand of bone screws are intended for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus,ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

AUXEIN Brand of DCS plate system is used to provide fixation of fractures to the proximal femur and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures.

The system is indicated for use in adult patients only. All implants are for single use only.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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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
Address:
Office:	103, First Floor,Jyoti Bhawan, Comm. Complex,Dr. Mukherjee Nagar,Delhi – 110009 (INDIA)
Factory:	Auxein Medical Pvt. Ltd.Plot Number 169-170, HSIIDC,Industrial Area, Kundli,District Sonepat,Haryana 131028 (India)
Contact Person Name:	Mr. Rahul Luthra
Title:	Director
Phone Number:	+91-9811720999
Dated:	10-06-2014

This is a bundled submission.

Throughout the submission there is a mention of Auxein Brand of Bone Plates and Bone Screws that represents the range of products covered under this 510(k) submission.

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a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Proprietary Name:

Auxein brand of bone plates and bone screws & auxein brand of DCS plate . system
Auxein brand of locking plates and locking screws .

Common or Usual Name:

Orthopaedic Bone Plates
Orthopaedic Bone Screws

Classification Name:

· PLATES, FIXATION, BONE
· SCREWS, FIXATION, BONE

Product Code:

HRS, HWC

Device Class: ll

Review Pane: Orthopaedic

Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040

Variants/Types:

Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws are further subdivided into following categories

S. No.	Category	Types
01	Mini Fragment Plates	Locking Version
02	Small Fragment Plates	Locking Version
03	Large Fragment Plates	Locking Version
04	Bone Screws	Locking Version

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Further Description of Auxein Brand Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws system

Generally there are following types of bone plates:

Dynamic Compression Type, .
. Special (for particular bones)
Mini fragment •

The aforementioned plates are used with cortical (cortex)-Locking Screws.

These bone plates are generally designed on the basis of the bone contour and anatomy.

S. No.	Type	Subtype
01	Mini Fragment	T-Shaped
02	Small and LargeFragment	T-Shaped, Hook, Angled Plates. Reconstructionsplates
03	Dynamiccompression	Small DCP, Narrow DCP, Lengthening Narrow, BroadDCP, Lengthening Broad Plates
04	DCS	DCS Plate

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A3) Identification of the Predicate Device:

Following are the predicate device 510(k) with which we are declaring substantial equivalence:

Following is the range of variants covered with their corresponding predicate devices.

S.N.	Item Description	Predicate Device
1.	2.4mm Wise-Lock "T" Distal Radius DorsalPlate, (3 Head Holes)	K012114 (Synthes locking distalradius plating system)
2.	2.4mm Wise-Lock Distal Radius VolarPlate, Extra-Articular, Left, (4 Head Holes)	LCP Radial Head PlatingSystem (K040777)
3.	2.4mm Wise-Lock Distal Radius VolarPlate, Extra-Articular, Right, (4 Head Holes)	LCP Radial Head PlatingSystem (K040777)
4.	2.7/3.5mm Wise-Lock Dorsolateral DistalHumerus Plate, Left Direction	Synthes 3.5mm LCP DistalHumerus System (K033995)
5.	2.7/3.5mm Wise-Lock Dorsolateral DistalHumerus Plate, Right Direction	Synthes 3.5mm LCP DistalHumerus System (K033995)
6.	2.7/3.5mm Wise-Lock Dorsolateral DistalHumerus Plate with Lateral Support, LeftDirection	Synthes 3.5mm LCP DistalHumerus System (K033995)
7.	2.7/3.5mm Wise-Lock Dorsolateral DistalHumerus Plate with Lateral Support, RightDirection	Synthes 3.5mm LCP DistalHumerus System (K033995)
8.	2.7/3.5mm Wise-Lock Medial Distal TibiaPlate, Left Direction	Synthes Medial Distal Tibia Plate(K001945)
9.	2.7/3.5mm Wise-Lock Medial Distal TibiaPlate, Right Direction	Synthes Medial Distal Tibia Plate(K001945)
10.	PHEELOS - Wise-Lock Proximal HumerusPlate	Synthes (USA) LCP® ProximalHumerus Plates, Long(K041860)
11.	3.5mm Wise-Lock Small DynamicCompression Plate with LC under cuts	Synthes 3.5 and 4.5mm LockingCompression Plate System
		(K082807)
12.	3.5mm Wise-Lock Proximal Humerus Plate	Proximal humerus plate longSynthes K041860
13.	3.5mm Wise-Lock Small 'T' Plate, ObliqueAngled - Left Direction	Synthes Small Fragment DynamicCompression Locking(DCL)System (K000684)
14.	3.5mm Wise-Lock Small 'T' Plate, ObliqueAngled - Right Direction	Synthes Small Fragment DynamicCompression Locking(DCL)System (K000684)
15.	3.5mm Wise-Lock Small 'T' Plate, RightAngled (3 Head Holes)	Synthes Small Fragment DynamicCompression Locking(DCL)System(K000684)
16.	Wise-Lock Small 'T' Plate, Right Angled (4Head Holes)	Synthes Small Fragment DynamicCompression Locking(DCL)System(K000684)
17.	3.5mm Wise-Lock Proximal Tibia Plate, LeftDirection	Synthes 3.5mm Titanium LCPProximal Tibia Plate (K030597)OR Synthes LCP Proximal TibiaPlates (K011978)
18.	3.5mm Wise-Lock Proximal Tibia Plate,Right Direction	Synthes 3.5mm Titanium LCPProximal Tibia Plate (K030597)OR Synthes LCP Proximal TibiaPlates (K011978)
19.	3.5mm Wise-Lock Anterolateral Distal TibiaPlates, Left	Synthes (USA) 2.7mm / 3.5mmLCP Anterolateral Distal TibiaPlates (K092812)
20.	3.5mm Wise-Lock Anterolateral Distal TibiaPlates, Right	Synthes (USA) 2.7mm / 3.5mmLCP Anterolateral Distal TibiaPlates (K092812)
21.	3.5mm Wise-Lock Clavicle Hook Plate, LeftDirection	Synthes Clavicle Hook Plate(K061753)
22.	3.5mm Wise-Lock Clavicle Hook Plate,Right Direction	Synthes Clavicle Hook Plate(K061753)
23.	4.5/5.0mm Wise Lock Broadly CurvedPlates	Synthes 3.5 mm and 4.5 mmCurved Narrow and BroadLocking Compression Plates(LCP) (K092609)
24.	4.5/5.0mm Wise-Lock ReconstructionPlates	Synthes 4.5 mm LCP StraightReconstruction Plate (K051986)
25.	4.5/5.0mm Wise Lock Broad LockingCompression Plate	Synthes 3.5 and 4.5mm LockingCompression Plate System(K082807)
26.	4.5/5.0mm Wise Lock Narrow LockingCompression Plate	Synthes 3.5 and 4.5mm LockingCompression Plate System(K082807)
27.	4.5/5.0mm Wise lock Distal Femur Plate	Synthes LCP Distal FemurPlates (K062564)
28.	4.5/5.0mm Wise Lock Lateral Tibia Plate	Synthes LCP Proximal TibiaPlate (K011978)
29.	4.5/5.0mm Wise Lock Proximal Femur plate	Synthes (USA) LCP ProximalFemur Plate and Screws(K030858)
30.	2.4mm Wise Lock Screw	Synthes2.4mm titanium locking screw(K033975)
31.	2.7 mm Wise Lock Screw	Synthes Small FragmentDynamic Compression Locking(DCL) System (K000684)
32.	3.5mm Wise lock screw	Synthes Small FragmentDynamic Compression Locking(DCL) System (K000684)
33.	5.0mm Wise lock Screw	Synthes Large FragmentDynamic Compression Locking(DCL) System (K000682)

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a4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device

Device Description:

Plate Fixation System

Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking Screws system consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws,

The plates and screws are fabricated from stainless steel and titanium.

These all are mainly divided into

. Mini Fragment Plates
. Small Fragment Plates
Large Fragment Plates .
DCS Plates. ●

The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.

The screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm

These implants are sold non-sterile, the products have to be sterilized prior to use.

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A5). (5) A statement of the intended use of the device

Indications for Use:

·AUXEIN Brand of Bone plates and bone screws are provided non-sterile.

AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System, AUXEIN brand of Locking Plates and Locking Screws.

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a6). Summary of Technological Characteristics as compared to the predicate devices:

Substantial equivalence including comparison with predicate devices

A comparison between the Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System, Auxein Brand of Locking Plates and Locking Screws 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 NewDevice (Auxein Brand)	Remarks
01	Indications for use	Similar intended use in New Deviceand Predicate device	Equivalent
02	Material	Same material used in New Deviceand Predicate device	Equivalent
03	PerformanceStandards	Same performance standards used inboth New Device as well as predicatedevice	Equivalent
04	Sterilization	Same method of sterilization used inboth New Device as well asPredicate device	Equivalent
05	DimensionalVerification	Same dimensions found in both NewDevice as well as Predicate device	Equivalent

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b1). 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 to first, as it is the basis of manufacturing metallic surgical implants.

We have complied to following material standards

1. ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
1. ASTM F 138: Standard Specification for Wrought 18 chromium-14Nickel-2.5Molybdenum stainless steel bar and wire for surgical implants.
1. ASTM F 139: Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants

We have verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission.

B: Performance Standards:

The device performance of Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws has been demonstrated against following applicable standards

. ASTM F 382,
. ASTM F 384 and
. ASTM F 543.

For Bone Plates:

As per ASTM F 382 and ASTM F 384 Static Four Point Bend Test: Conforms, Dynamic Four Point Bend Test: Conforms

For Bone Screws:

As per ASTM F 543 :Torsional Properties: Conforms, Driving Torque : Conforms, Pull-out Test: Conforms

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b2). Discussion on the clinical evaluation referenced and relied upon:

Auxein Brand of devices are of similar design and pattern as well as similar intended use. Clinical information was not necessary to demonstrate substantial equivalence.

CONCLUSION:

General, Safety and Performance conclusion:

From the available data available we can justify that the Auxein Brand of Bone Plates and Bone Screws, Auxein Brand of DCS Plate System and Auxein Brand of Locking Plates and Locking Screws are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in a3. of 510(k) summary.

Hence our devices can be considered safe and effective for their intended use.

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.