(168 days)
No
The summary describes a traditional hip replacement system with mechanical components and does not mention any AI/ML capabilities or related performance studies.
Yes
Explanation: The device is a hip replacement system, indicated for conditions like osteoarthritis and rheumatoid arthritis, aiming to restore patient mobility and reduce pain. These are therapeutic objectives, and the device directly treats the underlying medical condition.
No
Explanation: This device is a hip replacement system, designed to replace damaged hip joints. Its purpose is therapeutic (reducing pain and improving mobility) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly lists multiple hardware components, including acetabular cups, femoral stems, and accessories like screws and centralizers. The performance studies also focus on the mechanical properties and testing of these physical components.
Based on the provided information, the Libertas™ 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 is a surgical procedure involving the implantation of a medical device, not a test performed on samples taken from the body.
- Device Description: The device components are physical implants (acetabular cup system, femoral stem, accessories) designed to replace a joint. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The performance studies listed are also focused on the mechanical and material properties of the implant, which is typical for a surgical device, not an IVD.
Therefore, the Libertas™ Hip Replacement System is a surgical implant, not an In Vitro Diagnostic device.
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 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.
Product codes
JDI, LZO
Device Description
The Libertas™ Hip Replacement System consists of the following components:
● Acetabular Cup System
-
Modular Shell
-
Modular Liner HXLPE
-
Cobalt Chromium alloy 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
-
Screw Hole Occluder
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)
The components of Libertas "" Hip Replacement System were subjected to the following non-clinical performance testing to evaluate device function/mechanical performance.
- Axial Disassembly (Push Out) test (ASTM F 1820-2013) .
- Offset pull out (Lever Out) Disassembly (ASTM F 1820-2013) .
- Torque Out Disassembly (ASTM F 1820-2013) .
- Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2011) ●
- HA coating adhesion (shear) test (ASTM F1044-05, Reapproved-2011) .
- Impingement test (ASTM F2582-14)
- Fretting Corrosion (ASTM F1875-98; Reapproved 2014)
- Axial pull-off test (ISO 7206-10-2003)
- Proximal fatigue test (ISO 7206-6-2013) ●
- Distal Fatigue test (ISO 7206-4-2010) ●
- Range of motion test (ISO 21535-2007)
- Bone Screw Torsion properties (ASTM F543-13e) ●
- Bone Screw Pull out properties (ASTM F543- 13e)
- Bone Screw Driving torque test (ASTM F543- 13e) ●
- o 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 (ISO 7206-10)
- . Torque test for Biolox® delta Modular Femoral head (ASTM F1820)
- Material characterization of HXLPE material. .
- Engineering rationale for wear test ●
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)
K172857, K110087, K103120, K130343, K111481, K093472, K042992, K110290, K933077, K974054
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 28, 2018
Maxx Orthopedics, Inc % Hollace Rhodes Senior Director Musculoskeletal Clinical Regulatory Advisors, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K180973
Trade/Device Name: Libertas Hip Replacement System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LZO Dated: August 27, 2018 Received: August 28, 2018
Dear Ms. Rhodes:
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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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.
Daniel S. Ramsey -S 2018.09.28 12:03:45 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180973
Device Name Libertas™ Hip Replacement System
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 teplacing 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 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 and 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in a bold, sans-serif font and is colored blue. Below the word "maxx" is an orange line, and below the line is the word "orthopedics" in a smaller, blue, sans-serif font.
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92.
Date of Summary: September 26, 2018
Applicant Maxx Orthopedics Inc. 531 Plymouth Road, Suite 526 Plymouth Meeting, PA 19462 USA
Maxx Orthopedics Contact Information:
Contact Person
Corey Perine Chief Operating Officer Email: corey.perine@maxxortho.com Phone: +1- 484.342.0092 Cell: +1 - 215.432.4323
Alternate Contact: Bhavik Gondaliya Regulatory & Clinical Consultant Email: bhavik.gondaliya@maxxortho.com Cell: +91 - 7383919414
Regulatory Correspondent:
Hollace Saas Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 Email: hrhodes@mcra.com Phone: +1-202-552-5807
Device information:
| Proprietary Name: | Libertas™ 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 | |
| Hip joint metal/polymer semi-constrained cemented | |
| prosthesis per 21 CFR 888.3350 | |
| Product Codes: | JDI, LZO |
| Device Class: | Class II |
4
Image /page/4/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in a larger, bold, blue font. There is an orange line underneath the word "maxx". The word "orthopedics" is in a smaller, blue font and is located underneath the orange line.
Predicate Devices
| Component | Predicate Device | Manufacturer | Submission Number |
|---|---|---|---|
| Acetabular Cup | |||
| System | Latitud Hip System | Meril | K172857 |
| Corin's Trinity | |||
| Acetabular System | |||
| Includes Modular shell, | |||
| Modular liner | |||
| (HXLPE), Cobalt- | |||
| Chromium alloy and | |||
| Biolox® delta Modular | |||
| Femoral Head, Bone | |||
| Screw, Apical Hole | |||
| Occluder and Screw | |||
| Hole Occluder | Corin USA | K110087, K103120, | |
| K130343, K111481: For | |||
| Shell, HXLPE liner, | |||
| Cobalt Chromium alloy | |||
| and Biolox® delta | |||
| Modular Femoral Head | |||
| K093472: For Bone | |||
| screw, Apical Hole | |||
| Occluder and Screw | |||
| Hole Occluder. | |||
| DePuy's Pinnacle | |||
| acetabular cup system | |||
| is identified as a | |||
| reference device | DePuy | ||
| Orthopaedics Inc. | K000306, K033273 | ||
| Uncemented | |||
| femoral stem | DePuy's Corail® HA | ||
| Coated hip Stem | DePuy | ||
| Orthopaedics | 510(k) Number: | ||
| K042992 | |||
| Latitud Hip System | Meril | K172857 | |
| Cemented femoral | |||
| stem | Stryker's Exeter® Hip | ||
| Stem (Includes | |||
| Cemented stem, | |||
| Cement restrictor and | |||
| Centralizer) | Stryker®, | ||
| Howmedica | |||
| Osteonics, USA | 510(k) Number: | ||
| K110290: Stem | |||
| K933077: Cement | |||
| restrictor | |||
| K974054 : Centralizer | |||
| Latitud Hip System | Meril | K172857 |
5
maxx orthopedics
K180973
Device Description:
The Libertas™ Hip Replacement System consists of the following components:
● Acetabular Cup System
-
Modular Shell
-
Modular Liner HXLPE
-
Cobalt Chromium alloy 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
-
Screw Hole Occluder
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 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.
6
Image /page/6/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is written in large, bold, blue letters. Below the word "maxx" is a thin orange line, and below that is the word "orthopedics" in smaller, blue letters.
NOTE:
- The Modular Shell and Uncemented Stem are intended are intended for press-● fit, uncemented use only.
- The Cemented stem is intended for cemented use only. o
Comparison of Technological Characteristics:
The Libertas" 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.
Non Clinical Performance Data:
The components of Libertas "" Hip Replacement System were subjected to the following non-clinical performance testing to evaluate device function/mechanical performance.
- Axial Disassembly (Push Out) test (ASTM F 1820-2013) .
- Offset pull out (Lever Out) Disassembly (ASTM F 1820-2013) .
- Torque Out Disassembly (ASTM F 1820-2013) .
- Ti coating adhesion (shear) test (ASTM F1044-05; Reapproved 2011) ●
- HA coating adhesion (shear) test (ASTM F1044-05, Reapproved-2011) .
- Impingement test (ASTM F2582-14)
- Fretting Corrosion (ASTM F1875-98; Reapproved 2014)
- Axial pull-off test (ISO 7206-10-2003)
- Proximal fatigue test (ISO 7206-6-2013) ●
- Distal Fatigue test (ISO 7206-4-2010) ●
- Range of motion test (ISO 21535-2007)
- Bone Screw Torsion properties (ASTM F543-13e) ●
- Bone Screw Pull out properties (ASTM F543- 13e)
- Bone Screw Driving torque test (ASTM F543- 13e) ●
- o 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 (ISO 7206-10)
- . Torque test for Biolox® delta Modular Femoral head (ASTM F1820)
- Material characterization of HXLPE material. .
- Engineering rationale for wear test ●
Endotoxin testing has demonstrated that the manufacturing process does not introduce Endotoxin as a bi-product of the manufacturing and cleaning process.
7
Image /page/7/Picture/0 description: The image shows the logo for Maxx Orthopedics. The word "maxx" is in a bold, dark blue font, with a thin orange line underneath it. Below the orange line, the word "orthopedics" is written in a smaller, lighter blue font.
Conclusion
Based on performance testing results and similarities in intended use, device design/technological characteristics, materials, and sterilization method, the Libertas™ Hip Replacement System is considered substantially equivalent to the previously cleared predicate devices.