(238 days)
No
The document describes a mechanical hip replacement system and its materials and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide patient mobility and reduce pain by replacing damaged hip joint articulation, which directly contributes to the treatment and management of medical conditions like osteoarthritis, rheumatoid arthritis, and bone fractures.
No
This device is a hip implant, specifically a hip replacement system, used in total hip arthroplasty to replace damaged hip joint articulation. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "femoral stem fabricated from Ti6Al4V - ELI" and mentions physical testing like fatigue and pull-off tests, indicating it is a physical implant, not software.
Based on the provided information, the Libertas™ Hip Replacement System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "total hip arthroplasty" to "provide patient mobility and reduce pain by replacing the damaged hip joint articulation." This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The description details the materials and design of a femoral stem, which is a component of a hip implant.
- Performance Studies: The performance studies listed are mechanical and material tests (fatigue, range of motion, pull-off, corrosion, etc.) relevant to the physical function and durability of an implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Libertas™ Hip Replacement System is an in vivo device, meaning it is implanted within the body.
N/A
Intended Use / Indications for Use
The Libertas™ 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 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 nonunion, femoral neck and trochanteric fractures of the proximal femur.
NOTE: - The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
- The Cemented stem is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
Libertas™ Hip Replacement System cleared under K180973 consists of a modular acetabular cup system, femoral heads, femoral stems, and related accessories.
The purpose of this 510(k) is to add Taper uncemented femoral stem under the Libertas™ Hip device family.
The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced 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 was conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence.
- Proximal fatigue test (ISO 7206-6:2013)
- 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
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.
Based on performance testing results and similarities in intended use, device design/technological characteristics, material, and sterilization method, the Libertas™ - Taper uncemented femoral stem is considered substantially equivalent to the previously cleared predicate device.
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.
K120030, K110400, K103755, K101086, K062994, K043537, K921301
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.
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.
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August 23, 2019
Image /page/0/Picture/1 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Maxx Orthopedics Inc. Priscilla Herpai Regulatory Manager 2460 General Armistead Ave, Suite 100 Norristown, Pennsylvania 19403
Re: K183684
Trade/Device Name: Libertas - Taper Uncemented Femoral Stem 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: July 8, 2019 Received: July 26, 2019
Dear Priscilla Herpai:
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 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
1
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 mediation-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 Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices 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)
K183684
Device Name Libertas™ - Taper uncemented femoral stem
Indications for Use (Describe)
The Libertas™ 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 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 nonunion, femoral neck and trochanteric fractures of the proximal femur.
NOTE:
- · The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
- · The Cemented stem is intended for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in bold, black letters, with a gray line underneath. Below the line, the word "orthopedics" is written in a smaller, black font. The logo is simple and modern.
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 92.
Applicant
Date of Summary: December 27, 2018
Maxx Orthopedics Inc. 2460 General Armistead Ave Suite 100, Norristown, PA 19403 USA
| Contact Person | Alternate Contact: |
|---|---|
| Priscilla Herpai | Gayathri Nair |
| Regulatory Manager | Senior Manager – Regulatory Affairs/Quality Assurance |
| Maxx Orthopedics, Inc. | Email: gayathri.nair@merillife.com |
| Phone: +1 484.342.0092 x 507 | Cell: +91 9909033393 |
| Email: priscilla.herpai@maxxortho.com |
Device information:
| Proprietary Name: | LibertasTM – Taper Uncemented Femoral Stem |
|---|---|
| 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 Codes: | LZO |
| Device Class: | Class II |
Predicate Devices
| Equivalent
| device category | Manufacturer | Trade name | 510(k) |
|---|---|---|---|
| Predicate device | Biomet Manufacturing | ||
| Corp., USA | Taperloc® Complete Stems | ||
| Taperloc® Complete Microplasty | |||
| System | K120030, | ||
| K110400, | |||
| K103755, | |||
| K101086, | |||
| K062994, | |||
| K043537, | |||
| K921301, |
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| Equivalent
| device category | Manufacturer | Trade name | 510(k) |
|---|---|---|---|
| Reference | |||
| Device | Maxx Orthopedics, | ||
| Inc, USA | Libertas™ – Hip | ||
| Replacement System | K180973 | ||
| Reference | |||
| Device | Meril Healthcare Pvt. | ||
| Ltd., India | Latitud™ – Hip Replacement | ||
| System | K172857 |
Device Description:
Libertas™ Hip Replacement System cleared under K180973 consists of a modular acetabular cup system, femoral heads, femoral stems, and related accessories.
The purpose of this 510(k) is to add Taper uncemented femoral stem under the Libertas™ Hip device family.
The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).
Intended use/Indications:
The Libertas™ 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 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 nonunion, femoral neck and trochanteric fractures of the proximal femur. .
NOTE:
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Image /page/5/Picture/1 description: The image shows the logo for Maxx Orthopedics. The logo consists of the word "maxx" in bold, black letters, with a gray curved line underneath. Below the line, the word "orthopedics" is written in a smaller, sans-serif font, also in black.
- The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, . uncemented use only.
- . The Cemented stem is intended for cemented use only.
Comparison of technological characteristics:
The subject device is substantially equivalent to the previously cleared predicate devices based on similarities in intended use and technological characteristics, and sterilization method.
Non clinical Performance data:
Non-clinical testing was conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence.
- Proximal fatigue test (ISO 7206-6:2013)
- 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
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.
Conclusion
Based on performance testing results and similarities in intended use, device design/technological characteristics, material, and sterilization method, the Libertas™ - Taper uncemented femoral stem is considered substantially equivalent to the previously cleared predicate device.