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, post-traumatic arthritis 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 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™ Hip Replacement System consists of following components:
Acetabular Cup System

Modular Shell / Cup
Modular Liner
Cobalt Chromium Modular Femoral Head
Biolox® delta Modular Femeral Head
Femoral Stem
Uncemented Femoral Stem
Cemented Femoral Stem
Accessories (Sub components)
Bone Screw
Apical Hole Occluder
Centralizer
Cement Restrictor

Acetabular cup system is a modular acetabular replacement system consisting of a range of Modular Shells, Modular Liners, Cobalt chromium alloy and Biolox® delta Modular Femoral Heads. The Modular Shells are designed for use with dedicated sizes of Modular Liners articulating with a range of dedicated Cobalt chromium alloy and Biolox® delta Modular Femoral Heads.

Modular Shell: Modular Shell is intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shell is fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shell is available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium. Two/Three screw holes are provided in Modular shell for additional immediate fixation with bone by means of Bone screws. A threaded apical hole is provided to attach instruments for surgical insertion. After fixation of Modular shell, apical hole will occlude by Occluder.

Modular Liner: Modular liner is designed to be used with Modular shell and articulate with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads. Modular liner is fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.

Cobalt chromium Modular Femoral Head: Modular femoral head fabricated from cobalt chromium alloy is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.

Biolox® Delta Modular Femoral Head: Modular femoral head fabricated from ceramic material (Biolox® delta, by CeramTec. Germany) is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.

Uncemented Femoral Stem: The Uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. 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 three different neck angles. Uncemented femoral stem is intended for press-fit uncemented use only.

Cemented Femoral Stem: Cemented femoral stem is fabricated from High Nitrogen Stainless Steel (HNSS). It has 12/14 taper trunnion at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted with use of bone cement. These stems are available in different sizes with two different offsets. Cemented stem is intended for cemented use only.

Accessories (Subcomponents):
Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.

Apical Hole Occluder: Apical hole occluder is provided to occlude the apical hole after fixation of the Modular shell in acetabulum. Apical hole occluder is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Apical hole occluder is available in one size.

Centralizer: Centralizer is used for correct positioning of Cemented stem in medullary canal of femur. Centralizer is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Centralizer is designed to be used with Cemented stem only. Centralizer is offered in two sizes.

Cement Restrictor: Cement restrictor is used to occlude and seal intramedullary canal in order to generate sufficient pressure to enhance cement penetration and to prevent distal cement leakage. Cement restrictor is designed to be used with Cemented stem only. Cement restrictor is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Cement restrictor is provided in two sizes.

AI/ML Overview

The provided text is a 510(k) Summary for the Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance testing, rather than presenting a clinical study with acceptance criteria and device performance as one might find for a novel diagnostic or therapeutic device.

Therefore, the requested information elements related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract information related to the non-clinical performance data and the conclusion on substantial equivalence.

Here's the relevant information that can be extracted:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM and ISO standards for mechanical testing of orthopedic implants. The document states that the system "was subjected to following nonclinical performance testing to evaluate device function/mechanical performance." The implication is that the device met the requirements of these standards. Specific numerical acceptance criteria and precise performance values are not detailed in this summary; rather, the successful completion of these tests serves as the proof of meeting criteria for substantial equivalence.

Acceptance Criteria Category (as per referenced standard)	Reported Device Performance (Implied by successful testing)
Material/Component Properties:
Ti coating adhesion (shear) (ASTM F1044-05)	Met requirements of ASTM F1044-05
HA coating adhesion (shear) (ASTM F1044-05)	Met requirements of ASTM F1044-05
Bone Screw Torsion properties (ASTM F543-13e)	Met requirements of ASTM F543-13e
Bone Screw Pull out properties (ASTM F543-13e)	Met requirements of ASTM F543-13e
Bone Screw Driving torque test (ASTM F543-13e)	Met requirements of ASTM F543-13e
Bone Screw Self tapping performance (ASTM F543-13e)	Met requirements of ASTM F543-13e
Acetabular Cup System Performance:
Axial Disassembly (Push out) (ASTM F1820-2013)	Met requirements of ASTM F1820-2013
Offset pull out (Lever Out) (ASTM F1820-2013)	Met requirements of ASTM F1820-2013
Torque Out Disassembly (ASTM F1820-2013)	Met requirements of ASTM F1820-2013
Wear test (ISO 14242-3-2009 & ISO 14242-2-2014)	Met requirements of ISO 14242-3-2009 & ISO 14242-2-2014
Impingement test (ASTM F2582-14)	Met requirements of ASTM F2582-14
Burst test, Fatigue test, Post fatigue burst test, Pull-off test for Biolox® delta Modular femoral head and Uncemented Femoral Stem (ISO 7206-10)	Met requirements of ISO 7206-10
Torque test for Biolox® delta Modular Femoral head (ASTM F1820) / Torsional resistance test (ISO 7206-13)	Met requirements of ASTM F1820 / ISO 7206-13
Burst test for Biolox® delta Modular femoral head and Cemented Femoral Stem	Met requirements (standard not explicitly stated for this specific test)
Femoral Stem Performance:
Fretting Corrosion (ASTM F1875-98) (Uncem. & Cem. Stems)	Met requirements of ASTM F1875-98
Axial pull-off test (ISO 7206-10-2003) (Uncem. & Cem. Stems)	Met requirements of ISO 7206-10-2003
Proximal fatigue test (ISO 7206-6-2013) (Uncem. & Cem. Stems)	Met requirements of ISO 7206-6-2013
Distal fatigue test (ISO 7206-4-2010) (Uncem. & Cem. Stems)	Met requirements of ISO 7206-4-2010
System Level Performance:
Range of motion test (ISO 21535-2007)	Met requirements of ISO 21535-2007
Endotoxin testing (USP sterility & Endotoxin)	Demonstrated manufacturing process does not introduce Endotoxin, confirmed by 14-day USP sterility testing and USP Endotoxin testing prior to release.

1. A table of acceptance criteria and the reported device performance
See table above. The "reported device performance" is implied by the statement "subjected to following nonclinical performance testing to evaluate device function/mechanical performance" and the overall conclusion of substantial equivalence. For 510(k) submissions based on mechanical testing, specific numerical results are often contained in the full submission, but the summary confirms successful completion against established standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the summary document. Mechanical testing for these types of devices typically involves a specified number of samples per test condition as dictated by the respective ASTM/ISO standards.
Data Provenance: Not explicitly stated as "country of origin of the data." The applicant is Meril Healthcare Private Limited, based in Gujarat, INDIA. The testing was non-clinical (laboratory/mechanical testing), not human data.
Retrospective or Prospective: Not applicable, as this is non-clinical performance data (material and mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) for an orthopedic implant, where "ground truth" is established by adherence to recognized mechanical and materials testing standards, not by expert medical interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This describes non-clinical testing, not a clinical study requiring adjudication of expert opinions.

5. 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
Not applicable. This is a 510(k) for an orthopedic implant, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for an orthopedic implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission are the established specifications and performance requirements outlined in the referenced ASTM and ISO consensus standards for orthopedic implants. Successful demonstration of meeting these standards through mechanical and material testing serves as the basis for substantial equivalence.

8. The sample size for the training set
Not applicable. This is a 510(k) for an orthopedic implant based on non-clinical performance and substantial equivalence to predicate devices, not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font, also in blue.

July 19, 2018

Meril Healthcare Pvt. Ltd. % Linda Braddon President & Chief Executive Officer Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock. Georgia 30188

Re: K172857

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: June 22, 2018 Received: June 22, 2018

Dear Linda Braddon:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vincent J. Devlin -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K172857

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, post-traumatic arthritis 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 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.

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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5. 510(k) SUMMARY

510(k) Summary

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

5.1 Applicant:

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

5.2 Regulatory Correspondent:

Linda Braddon, Ph.D. President and CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA, 30188 Email: 1gb@securebme.com Phone: + 1 - 770-837-2681

Meril Healthcare Contact Information:

Bhavik Gondaliya Manager - Regulatory Affairs 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 Cell: +91 - 9687604713 E mail: bhavik.gondaliya@merillife.com

5.3 Date prepared: 18 July 2018

5.4 Device information:Proprietary Name:	Latitud™ Hip Replacement System
Common / Usual Name:	Hip Joint Prosthesis
Classification name:	Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis per 21 CFR888.3358

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Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353

Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350

Product Code: LPH, JDI, LZO

Device Class: Class II

Predicate Devices 5.5

Component	Predicate Device	Manufacturer	Submission Number
Acetabular CupSystem	Corin's TrinityAcetabular System(Includes Modularshell, Modular liner,Cobalt-Chromium alloyand Biolox® deltaModular Femoral head,Bone screw, ApicalHole occluder )	Corin USA	510 k Number:K110087, K103120,K130343 : For Shell,HXLPE liner, Cobalt-Chromium alloy andBiolox® delta ModularFemoral HeadK093472: For Bonescrew and Apical holeoccluder
	Depuy's PinnacleAcetabular System	DePuyOrthopaedics,Inc., USA	510k Number: K000306
Uncementedfemoral stem	Depuy's Corail® HACoated hip Stem	DepuyOrthopaedicsFrance S.A.S	510 k Number:K042992
Cemented femoralstem	Stryker's Exeter® HipStem (IncludesCemented stem,Cement restrictor andCentralizer)	Stryker®,HowmedicaOsteonics, USA	510 k Number:K110290: StemK980843: CementrestrictorK974054, K960258:Centralizer
	Distal centralizer ofNatural hip system	IntermedicsOrthopedics Inc.	K960258: Centralizer

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5.6 Device Description:

The Latitud™ Hip Replacement System consists of following components:

Acetabular Cup System ●

Modular Shell / Cup
Modular Liner
Cobalt Chromium Modular Femoral Head
Biolox® delta Modular Femoral Head

Femoral Stem ●

Uncemented Femoral Stem
Cemented Femoral Stem
Accessories (Sub components) ●
- Bone Screw
- Apical Hole Occluder
- Centralizer

Cement Restrictor

Acetabular Cup System

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Meril

Femoral Stem

Accessories (Subcomponents):

Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.

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5.7 Indications for use:

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, post-traumatic arthritis 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 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 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 ● Acetabular Liner to mate with uncemented stem or cemented stem.
The Biolox® delta Modular Femoral Head is intended to articulate with Modular Acetabular 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.

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Comparison of technological characteristics: 5.8

The Latitud™ Hip Replacement System is substantially equivalent to the previously predicate devices based on similarities in intended cleared use. device design/technological characteristics, materials, and sterilization method.

Non clinical Performance data: 5.9

The components of Latitud TM Hip Replacement System were subjected to following nonclinical performance testing to evaluate device function/mechanical performance.

· Axial Disassembly (Push out) test (ASTM F1820-2013)
· Offset pull out (Lever Out) test Disassembly (ASTM F1820-2013)
· Torque Out Disassembly test (ASTM F1820-2013)
· Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2011)
Wear test (ISO 14242-3-2009 & ISO 14242-2-2014)
· Impingement test (ASTM F2582-14) ( Acetabular Cup System)
· Fretting Corrosion (ASTM F1875-98; Reapproved 2014) (Uncemented Femoral Stem & Cobalt chromium Modular femoral head)
Axial pull-off test (ISO 7206-10-2003) (Uncemented Femoral Stem & Cobalt chromium Modular femoral head)
· Proximal fatigue test (ISO 7206-6-2013) (Uncemented Femoral Stem)
· Distal fatigue test (ISO 7206-4-2010) (Uncemented Femoral Stem)
· Range of motion test (ISO 21535-2007)
· HA coating adhesion (shear) test (ASTM F1044-05, Reapproved-2011)
Proximal fatigue test (ISO 7206-6-2013) (Cemented Femoral Stem)
· Distal fatigue test (ISO 7206-4-2010) (Cemented Femoral Stem)
· Fretting Corrosion (ASTM F1875-98; Reapproved 2014) (Cemented Femoral Stem and Cobalt chromium Modular femoral head)
· Axial pull-off test (ISO 7206-10-2003) (Cemented Femoral Stem & Cobalt chromium Modular femoral head)
· Bone Screw Torsion properties (ASTM F543-13e)
· Bone Screw Pull out properties (ASTM F543- 13e)
· Bone Screw Driving torque test (ASTM F543- 13e)
· Bone Screw Self tapping performance (ASTM F543- 13e)
· Burst test, Fatigue test, Post fatigue burst test, Pull-off test for Biolox® delta Modular femoral head and Uncemented Femoral Stem (ISO 7206-10)
Torque test for Biolox® delta Modular Femoral head (ASTM F1820) / Torsional resistance test (ISO 7206-13)
Burst test for Biolox® delta Modular femoral head and Cemented Femoral Stem

Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.

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Latitud™ Hip Replacement System is subjected to 14 day USP sterility testing and USP Endotoxin testing prior to release.

Meril Healthcare Pvt. Ltd. confirms that the Bacterial Endotoxin Test [(BET)/LAL test] will be conducted on final sterilized device of every batch prior to releasing to US market.

5.10 Conclusion

Based on performance testing results and similarities in intended use, device design/technological characteristics, materials, and sterilization method, the Latitud™ Hip Replacement System is considered substantially equivalent to the previously cleared predicate devices.

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.