The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Congenital hip dysplasia.
Acute traumatic fracture of the femoral head or neck.
Certain cases of Ankylosis.
Dislocation of the hip.
Correction of functional deformity.
Revision of failed joint reconstruction or treatment.
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Note:

· The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
· The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
· The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
· The Cemented Femoral stem is intended for cemented use only.
· The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.

· The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.

• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.

· The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.

· The Centralizer and Cement Restrictor are intended for use with cemented stem only.

Device Description

The Latitud™ Uncemented Femoral Stem is fabricated from Titanium alloy - ELI (Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with its 510(k) cleared Latitud™ Cobalt Chromium alloy and Biolox® delta Modular femoral head (Cleared under K172857). This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with neck angles of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only.

AI/ML Overview

The provided document is a 510(k) summary for the Meril Healthcare Pvt. Ltd. Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical context.

The document primarily describes non-clinical performance data and biocompatibility testing to support the substantial equivalence claim. It does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth establishment for a training set in the context of an AI/ML device. This is because the Latitud™ Hip Replacement System is a physical medical device (hip implant), not an AI/ML diagnostic or therapeutic system.

Therefore, many of the requested categories are not applicable to the content of this 510(k) summary. I will answer the applicable questions based on the provided text.

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are related to mechanical and chemical properties, as well as biocompatibility, conforming to established ASTM and ISO standards. The document summarizes that the device was subjected to these tests and the results support its substantial equivalence. Specific quantitative acceptance criteria or detailed performance values are not explicitly listed in a comparative table within the summary.

Mechanical Tests:

Test	Standard	Reported Performance
Bonding Strength	ASTM F1147-05 (Reapproved 2017)e1	Tested in accordance with the standard to support substantial equivalence.
Shear static strength	ASTM F1044-05 (Reapproved 2017)e1	Tested in accordance with the standard to support substantial equivalence.
Fatigue Shear test	ASTM F1160-14 (Reapproved 2017)e1	Tested in accordance with the standard to support substantial equivalence.
Fatigue bending test	ASTM F1160-14 (Reapproved 2017)e1	Tested in accordance with the standard to support substantial equivalence.

Morphology Tests:

Test	Standard	Reported Performance
Thickness and Porosity	ASTM F1854-15	Tested in accordance with the standard to support substantial equivalence.
Roughness Ra/Rt	ISO 4288- 1998	Tested in accordance with the standard to support substantial equivalence.
Scanning Electron Microscope (SEM)	FDA Guidance*	Tested in accordance with the FDA Guidance to support substantial equivalence.

Chemical Tests:

Test	Standard	Reported Performance
Trace elements and heavy metals by ICP	ISO 13779-2 (2018), ISO 13779-3 (2018)	Tested in accordance with the standards to support substantial equivalence.
Ca/P ratio and Phases and Crystallinity by XRD	ISO 13779-2 (2018), ISO 13779-3 (2018)	Tested in accordance with the standards to support substantial equivalence.
Fourier-transform infrared spectroscopy (FTIR)	FDA Guidance*	Tested in accordance with the FDA Guidance to support substantial equivalence.
Solubility	ISO 13779-6 (2015)	Tested in accordance with the standard to support substantial equivalence.
Dissolution	ASTM F1926/F1926M-14	Tested in accordance with the standard to support substantial equivalence.

Biocompatibility Tests: All tests were conducted according to ISO 10993 series standards (or USP General Chapter <151>). The conclusion states that the device is considered substantially equivalent, implying that these tests met the acceptance criteria.

Test	Standard
Cytotoxicity Test	ISO 10993-5
Skin Sensitization Study	ISO 10993-10
Acute irritation/Intracutaneous reactivity test	ISO 10993-23
Acute systemic toxicity study	ISO 10993-11
Material mediated pyrogenicity	ISO 10993-11, USP General Chapter <151>
Sub-chronic systemic toxicity test	ISO 10993-11
Bone Implantation Study	ISO 10993-6
Bacterial Reverse Mutation Test	ISO 10993-3
In vitro Mammalian Chromosomal Aberration Test	ISO 10993-3

*FDA guidance document- "510(k) Information needed for Hydroxyapatite coated orthopedic implants. February 1997"

Applicable Questions:

As this is a 510(k) for a physical medical device (hip implant) and not an AI/ML software, the following points are not applicable from the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Meril Healthcare Pvt. Ltd. Yamini Patel Manager - Regulatory Affairs Survey No. 135/2/B & 174/2, H1-H3, Meril Park, Muktanand Marg, Chala Vapi. Gujarat 396191 India

Re: K222436

Trade/Device Name: Latitud™ Hip Replacement System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LZO Dated: April 14, 2023 Received: April 14, 2023

Dear Yamini Patel:

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

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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,

Image /page/1/Picture/5 description: The image shows the words "Limin Sun-S" in a large, sans-serif font. The text is black against a white background. The words are arranged horizontally, with "Limin" on the left, "Sun" in the middle, and "-S" on the right. The letters are evenly spaced and easy to read.

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222436

Device Name Latitud™ Hip Replacement System

Indications for Use (Describe)

Total hip replacement is indicated for the following conditions:

Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Congenital hip dysplasia.
Acute traumatic fracture of the femoral head or neck.
Certain cases of Ankylosis.
Dislocation of the hip.
Correction of functional deformity.
Revision of failed joint reconstruction or treatment.
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.

Note:

· The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
· The Hydroxyapatite Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
· The Proximally Coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
· The Cemented Femoral stem is intended for cemented use only.
· The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.

· The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.

• The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.

· The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.

· The Centralizer and Cement Restrictor are intended for use with cemented stem only.
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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.

1.

Meril Healthcare Private Limited Survey No. 135/2/B & 174/2, First Floor, H1-H3, Meril Park, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA

Primary Contact Person: 2.

Yamini Patel Manager- Regulatory Affairs E mail: yamini.patel@merillife.com Cell: +91 9714408139

Secondary Contact Person: 3.

Gayathri Nair DGM- Regulatory Affairs / Quality Assurance E mail: gayathri.nair@merillife.com Cell: +91 9909033393

Date prepared: 09 May 2023 4.

Device information: ട്.

Proprietary Name: Latitud™ Hip Replacement System

Common / Usual Name: Hip Joint Prosthesis

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Image /page/5/Picture/1 description: The image provides information on the classification name, product codes, and device class of hip joint prostheses. The classification names include hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR 888.3358, hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353, and hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350. The product codes are LPH, JDI, and LZO, and the device class is Class II.

Predicate Devices: 6.

Component	Predicate Device	Manufacturer	510(K)Number
Latitud™ HipReplacement System(HydroxyapatiteCoated UncementedFemoral Stem)	Latitud™ HipReplacement System	Meril Healthcare Pvt.Ltd.	K172857

Device Description: 7.

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Image /page/6/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The word is in white text on a blue background. There are two dots above the "i" in "Meril", one is yellow and the other is white.

of 135° standard, 135° lateral and 125° standard (Coxavera). Uncemented Femoral Stem is intended for press-fit uncemented use only.

Intended use/Indications: 8.

The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is an evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

Non-inflammatory degenerative joint diseases including osteoarthritis, posttraumatic arthritis and avascular necrosis.
A Rheumatoid arthritis.
Congenital hip dysplasia. A
Acute traumatic fracture of the femoral head or neck.
A Certain cases of Ankylosis.
A Dislocation of the hip.
Correction of functional deformity. A
A Revision of failed joint reconstruction or treatment.
Treatment of non-union, femoral neck and trochanteric fractures of the proximal A femur.

Note:

The Titanium coated Modular Acetabular Shell is intended for press-fit, . uncemented use only.
. The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, Uncemented use only
The Proximally Coated Uncemented Femoral Stem is intended for press-fit, . Uncemented use only.
The Cemented Femoral stem is intended for cemented use only.
The Modular Acetabular Liner is intended for use with Modular Acetabular Shell. .

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Meri

The CoCr Modular Femoral Head is intended to articulate with Modular . Acetabular Liner to mate with uncemented stem or cemented stem.
. The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular Liner to mate with uncemented stem or cemented stem.
. The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.
. The Centralizer and Cement Restrictor are intended for use with cemented stem only.

9. Comparison of Technological characteristics:

The subject device is substantially equivalent to legally marketed predicate device with respect to intended use, materials, device design, technological characteristics and manufacturing process including sterilization. The only difference between the subject device and the legally marketed device is the facility where the coating is performed. However, difference in coating facility between subject device and predicate device, does not raise new question of safety and effectiveness

10. Non clinical Performance data:

The subject device was subjected to non-clinical performance testing to evaluate device function/mechanical performance in accordance with applicable ASTM and ISO standard and FDA guidance. The tests include testing on the subject device and the HA powder.

Testing on subject device includes;

Mechanical tests: .
- Bonding Strength (ASTM F1147-05 (Reapproved 2017)e1)
- Shear static strength (ASTM F1044-05 (Reapproved 2017)e1) A
- Fatigue Shear test (ASTM F1160-14 (Reapproved 2017)e1)
- Fatigue bending test (ASTM F1160-14 (Reapproved 2017)e1)

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. Morphology tests:
Meril
A Thickness and Porosity (ASTM F1854-15)
Roughness Ra/Rt (ISO 4288- 1998) A
Scanning Electron Microscope (SEM) (FDA Guidance*)
. Chemical tests:
- Trace elements and heavy metals by ICP (ISO 13779-2 (2018), ISO 13779-3 (2018))
- Ca/P ratio and Phases and Crystallinity by XRD (ISO 13779-2 (2018), ISO 13779-3 (2018))
- A Fourier-transform infrared spectroscopy (FTIR) (FDA Guidance*)
- Solubility (ISO 13779-6 (2015))
- Dissolution (ASTM F1926/F1926M-14)
. Testing on HA powder includes;
- A Granulometry by sieving (ISO 2591-1 (1998))
- Granulometry by laser diffraction (ISO 24235 (2007)) A
- A Morphology by Scanning Electron Microscope (SEM) (ISO 13779-6 (2015))
- Trace elements and heavy metals by ICP (ISO 13779-3 (2018))
- Ca/P ratio & Phases and Crystallinity by XRD (ISO 13779-3 (2018))
- Molecular constitution by Fourier-transform infrared spectroscopy (FTIR) (FDA Guidance*)

*FDA guidance document- "510(k) Information needed for Hydroxyapatite coated orthopedic implants. February 1997"

11. Summary of Biocompatibility testing:

· Cytotoxicity Test ISO 10993-5
· Skin Sensitization Study ISO 10993-10
· Acute irritation/Intracutaneous reactivity test ISO 10993-23
· Acute systemic toxicity study ISO 10993-11
· Material mediated pyrogenicity ISO 10993-11, USP General Chapter <151>
· Sub-chronic systemic toxicity test ISO 10993-11

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Bone Implantation Study ISO 10993-6
Bacterial Reverse Mutation Test ISO 10993-3
· In vitro Mammalian Chromosomal Aberration Test ISO 10993-3

Conclusion: 12.

Based on performance testing results and similarities in intended use, manufacturing process, device design/technological characteristics, materials, and sterilization method, the subject device is considered substantially equivalent to the previously cleared predicate device.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.