(282 days)
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.
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.
This document is a 510(k) premarket notification for the MALUC™ Total Hip Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, device performance, and study design for clinical effectiveness is not present in this submission.
Here's a breakdown of what information can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The submission states that non-clinical mechanical testing was performed in accordance with several ISO and ASTM standards, and the device "met all predetermined acceptance criteria." It also mentions bacterial endotoxin testing which "met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values are not provided in this public summary.
| Acceptance Criteria Category | Reported Device Performance | Specific Criteria & Performance Values (not provided) |
|---|---|---|
| Mechanical Testing | Met all predetermined acceptance criteria | N/A |
| Bacterial Endotoxin Testing | Met predetermined acceptance criteria | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical test set or data provenance is mentioned for device performance. The submission explicitly states: "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The tests performed are non-clinical (mechanical and endotoxin).
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)
This information is not applicable as no clinical study involving human interpretation or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring adjudication is described.
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
This information is not applicable as this is a hip arthroplasty system, not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as no clinical ground truth was established for device performance in this submission. The "ground truth" for the non-clinical tests would be the established standards and specifications (e.g., ISO 21535, ASTM F2996, USP <85>), and the device's ability to meet those.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, this is not an AI model.
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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
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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
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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
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| (a)(1) | Submitted By: | SurgTech, Inc.24600 Center Ridge Road, Suite 195Westlake, 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
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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 <85> 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.
§ 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.