(211 days)
Not Found
No
The 510(k) summary describes a mechanical hip replacement system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on mechanical and material properties.
Yes
The device, the Latitud™ Hip Replacement System, is intended to provide patient mobility and reduce pain by replacing the damaged hip joint, which are therapeutic goals.
No.
This device, the Latitud™ Hip Replacement System, is a total hip arthroplasty system intended for replacing damaged hip joint articulation. It is a therapeutic device designed for surgical intervention and treatment, not for diagnosing conditions.
No
The device description clearly states it consists of physical components like acetabular cups, femoral heads, femoral stems, liners, and bone screws, all fabricated from materials like Titanium alloy and Polyethylene. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the Latitud™ Hip Replacement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "total hip arthroplasty" to "provide patient mobility and reduce pain by replacing the damaged hip joint articulation." This describes a surgical procedure and the replacement of a physical body part.
- Device Description: The description details the components of the system (acetabular cup system, femoral heads, femoral stems, bone screws) and their materials. These are all physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing diagnostic information about a patient's condition.
- Using reagents or assays.
The device is a surgical implant intended for the treatment of various hip conditions, not for diagnosing them.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
Latitud™ Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femoral heads, femoral stems and related accessories.
Purpose of this 510(k) is to add following acetabular cup system and femoral stem under previously 510 (k) cleared Latitud Hip Replacement System (K172857).
- Latitud TM Triad Acetabular Cup System.
- Latitud™ Proximally coated Uncemented femoral stem.
Latitud™ Triad - Acetabular Cup System
Latitud™ Triad - Acetabular cup system is a modular cup system. It includes Modular shells, Modular liners and Bone screws.
-
Modular Shell: Modular shells are intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shells are fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shells are available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium.
-
Modular Liner: Modular liners are designed to be used with Modular shell. Modular liners are intended to be articulated with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads previously cleared under K172857. Modular liners are fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.
-
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.
Latitud™ - Proximally coated uncemented femoral stem
The proximally coated uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Femoral head (CoCr and Biolox Delta ceramic) previously cleared under K172857. The proximal portion of the stem is coated with commercially pure Titanium with plasma spray method. The proximal coated femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design). Each design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence.
- o Locking Strength of modular acetabular cup and modular liner per ASTM F1820-13.
- Wear test (ASTM F1877-05, ISO 14242-3-2009).
- Impingement Test (ASTM F2582-14)
- Evaluation of torsion properties, pull out properties, driving torque, and self tapping performance of Bone Screw per ASTM F543-13e
- Proximal fatigue test (ISO 7206-6:2013).
- o Distal fatigue test (ISO 7206-4:2010)
- Range of motion test (ISO 21535-2007/Amd 1:2016).
- Axial pull-off test (ISO 7206-10:2003).
- Fretting corrosion (ASTM F1875-98; Reapproved 2014)
- Evaluation of Ceramic femoral head includes Burst test, Post fatigue burst test, Pull-off test (ISO 7206-10:2003) and Torque test (ASTM F1820-13) (Biolox® delta Modular femoral head and Uncemented Stem)
- Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2017)e1.
- Material Characterization of HXLPE (ASTM F2565-13, ASTM F2759-11, ASTM F648-14, ASTM F2003-15, ISO 5834-3 and ISO 5834-2)
Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K180973, K110087, K033273, K103384, K101086, K062994, K103755, K120030, K043537, K921301, K110400
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Meril Healthcare Pvt. Ltd. Gayathri Nair Senior Manager - Regulatory Affairs/Quality Assurance Survey No. 135/2/B & 174/2, First Floor, H1-H3, Meril Park, Muktanand Marg, Chala, Vapi - 396 191, Gujarat, INDIA
Re: K183532
Trade/Device Name: Latitud™ Hip Replacement System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 21, 2019 Received: June 25, 2019
Dear Gayathri Nair:
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.
July 18, 2019
1
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) 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.
FOR CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183532
Device Name Latitud™ Hip Replacement System
Indications for Use (Describe)
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.
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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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 Contact Person:
Gayathri Nair Senior Manager- Regulatory Affairs/ Quality Assurance Meril Healthcare Private Limited E mail: Gayathri.Nair(@merillife.com Cell: +91 9909033393
5.3 Date prepared: July16, 2019
Device information: 5.4
| Proprietary Name: | Latitud™ Hip Replacement System |
|---|---|
| Common / Usual Name: | Hip Joint Prosthesis |
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented |
| or nonporous uncemented prosthesis per 21 CFR 888.3353 | |
| Product Code: | LZO |
| Device Class: | Class II |
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Predicate Devices ર્ડ
ગુજરાત રાજ્યના અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને જિલ્લાના પાકની ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુ
Latitud™ Hip Replacement System is utilizing the following devices to demonstrate substantial equivalence. Libertas – Hip Replacement System (K180973) is considered as the primary predicate (same Indications for use) and all other devices are included for performance comparison.
| Manufacturer | Device Trade name | 510(k) # |
|---|---|---|
| Maxx Orthopedics Inc, USA | Libertas - Hip | |
| Replacement System | K180973 | |
| Corin, USA | Trinity Acetabular cup | |
| System | K110087 | |
| DePuy Orthopaedics, Inc., USA | Marathon Acetabular | |
| Liner | K033273 | |
| Ortho Development Corporation, | ||
| USA | Escalade Acetabular Cup | |
| System | K103384 | |
| Biomet Manufacturing Corp., | ||
| USA | Taperloc® Complete | |
| Stems | ||
| Taperloc® Complete | ||
| Microplasty System | K101086, | |
| K062994, | ||
| K103755, | ||
| K120030, | ||
| K043537, | ||
| K921301, | ||
| K110400 |
Device Description: 5.6
Latitud™ Hip Replacement System cleared under K172857 consists of modular acetabular cup system, femoral heads, femoral stems and related accessories.
Purpose of this 510(k) is to add following acetabular cup system and femoral stem under previously 510 (k) cleared Latitud Hip Replacement System (K172857).
- Latitud TM Triad Acetabular Cup System .
- Latitud™ Proximally coated Uncemented femoral stem .
Latitud™ Triad - Acetabular Cup System
Latitud™ Triad - Acetabular cup system is a modular cup system. It includes Modular shells, Modular liners and Bone screws.
- . Modular Shell: Modular shells are intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shells are fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shells are available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium.
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Image /page/5/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The letters are a light blue color, and the background is a darker blue. There are two small circles above the "i" in "Meril", one yellow and one white.
- Modular Liner: Modular liners are designed to be used with Modular shell. Modular liners . are intended to be articulated with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads previously cleared under K172857. Modular liners are fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.
- 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.
Latitud™ - Proximally coated uncemented femoral stem
The proximally coated uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Femoral head (CoCr and Biolox Delta ceramic) previously cleared under K172857. The proximal portion of the stem is coated with commercially pure Titanium with plasma spray method. The proximal coated femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design). Each design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).
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:
- o 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.
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Image /page/6/Picture/1 description: The image shows the word "Meril" in a sans-serif font. The letters are white against a blue background. There is a small yellow dot above the "i" in "Meril". The dot is slightly offset to the right.
- . The Proximally coated Uncemented femoral stem is intended for press-fit, uncemented use onlv.
- 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.
Comparison of technological characteristics: 5.8
The Latitud™ Hip Replacement System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, device design/technological characteristics, materials, and sterilization method.
5.9 Non clinical Performance data:
Non-clinical testing conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence.
- o Locking Strength of modular acetabular cup and modular liner per ASTM F1820-13.
- Wear test (ASTM F1877-05, ISO 14242-3-2009) .
- . Impingement Test (ASTM F2582-14)
- . Evaluation of torsion properties, pull out properties, driving torque, and self tapping performance of Bone Screw per ASTM F543-13e
- Proximal fatigue test (ISO 7206-6:2013) .
- o Distal fatigue test (ISO 7206-4:2010)
- Range of motion test (ISO 21535-2007/Amd 1:2016) .
- . Axial pull-off test (ISO 7206-10:2003)
- . Fretting corrosion (ASTM F1875-98; Reapproved 2014)
- Evaluation of Ceramic femoral head includes Burst test, Post fatigue burst test, . Pull-off test (ISO 7206-10:2003) and Torque test (ASTM F1820-13) (Biolox® delta Modular femoral head and Uncemented Stem)
- Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2017)e1 .
- Material Characterization of HXLPE (ASTM F2565-13, ASTM F2759-11, ASTM F648-14, . ASTM F2003-15, ISO 5834-3 and ISO 5834-2)
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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Image /page/7/Picture/1 description: The image features the word "Meril" in a sans-serif font against a light blue background. The letters are all lowercase except for the capital "M". Above the "i" is a small yellow circle, which serves as the dot for the "i". The overall design is simple and clean, with a focus on the text.
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.