(282 days)
Not Found
No
The summary describes a traditional mechanical implant system and its associated instrumentation, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device, a Total Hip Arthroplasty System, is used to replace severely painful and/or disabled joints due to various conditions, aiming to alleviate pain and restore function, which are therapeutic actions.
No
Explanation: The device is a total hip arthroplasty system intended for hip replacement, which is a surgical treatment, not a diagnostic procedure.
No
The device description explicitly lists physical components such as femoral stems, femoral heads, acetabular shells, liners, and instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating various conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a total hip arthroplasty system, consisting of physical components implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on mechanical testing and bacterial endotoxin testing, which are relevant to the safety and function of a surgical implant, not the diagnostic accuracy of an IVD.
In summary, the SurgTech MALUC™ System is a surgical implant used for treatment, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LPH, LZO
Device Description
The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
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: Mechanical testing in accordance with the following standards was performed and the subject MALUC™ THA System met all predetermined acceptance criteria: ISO 21535, ASTM F2996, ISO 7206-4, ISO 7206-6, ISO 7206-10, ASTM F2009, ASTM F1820, ASTM F543. Bacterial endotoxin testing was performed in accordance with USP and ANSI/AAMI ST72 and met the predetermined acceptance criteria.
Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
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.
K023453, K011623, K032300, K040412, K991952, K022077, K010757, K070885, K000306
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
§ 888.3350 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2017
SurgTech, Inc., % Kellen Hills Quality And Regulatory Consultant Orchid Design 4600 E Shelby Dr Memphis. Tennessee 38118
Re: K162125
Trade/Device Name: MALUCTM Total Hip Arthoplasty System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LPH, LZO Dated: April 7, 2017 Received: April 11, 2017
Dear Mr. Hills:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: QMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K 162125 (Page 1 of 1)
Device Name
MANDO Fotal Fotal Bo
Indications for Use (Describe)
The Surg Tech MALL C ™ System is intended for use for cases of severely painful and or disabled joint from osteoarthritis, traumatic arthritis or congenital hip dysplasia, avascular necrosis of the femoral head acute traumatic fracture of the femoral head or neck, failed previews hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and or total arthroplasty), and certain cases of ankylos
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
A STATE FOR FDA USE ONLY CARRET A BREAK A
oncurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
| (a)(1) | Submitted By: | SurgTech, Inc.
24600 Center Ridge Road, Suite 195
Westlake, OH 44145 |
|--------|------------------------------------|----------------------------------------------------------------------------|
| | Phone: | 901-433-1990 |
| | Fax: | 901-433-1989 |
| | Date: | April 7, 2017 |
| | Contact Persons | |
| | Primary: | Kellen Hills (Orchid Design Consulting) |
| | Secondary: | Brian Hewko (SurgTech, Inc.) |
| (a)(2) | Proprietary Name: | MALUC™ Total Hip Arthroplasty System |
| | Common Name: | Total Hip Prosthesis |
| | Classification Name and Reference: | 21CFR 888.3350, 888.3358, 888.3353 |
| | Product Code: | JDI, LPH, LZO |
- (a)(3) Predicate Devices: Primary:
Additional:
DePuy SUMMIT (K023453);
Stryker Exeter V40 (K011623); Stryker Accolade TMZF (K032300); Stryker Trident (K040412, K991952, K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306);
- (a)(4) Device Description:
The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.
The purpose of this submission is to gain initial marketing authorization in the United States.
(a)(5) Indications for Use:
The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.
- Comparison of Technological Characteristics: (a)(6) The MALUC™ Total Hip Arthroplasty System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and
4
mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy.
- (b)(1) Non-clinical testing:
Mechanical testing in accordance with the following standards was performed and the subject MALUC™ THA System met all predetermined acceptance criteria: ISO 21535, ASTM F2996, ISO 7206-4, ISO 7206-6, ISO 7206-10, ASTM F2009, ASTM F1820, ASTM F543.
Bacterial endotoxin testing was performed in accordance with USP and ANSI/AAMI ST72 and met the predetermined acceptance criteria.
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject MALUC™ Total Hip Arthroplasty System demonstrates substantial equivalence to the identified predicate devices.