(186 days)
The MRP-Titan system is intended to be used as the proximal part of a hip stem arthoplasty. The indications for use of the MRP-Titan system are revision operations and femur fractures of primary hip operated patients as well as tumour situations at the femur.
Primary and revision arthroplasty: Revision of primary hip stem prostheses
Fractures of the proximal femur
Tumor situation of the proximal femur
Reconstructions of the upper area of the proximal femur after both primary hip operation or traumafracture
Recovery of leg-lengthening
Improving antetorsion after failed primary hip stem operation
The patientmatched modular revision hip system MRP-Titan was developed to achieve best fixation of the stem in the femur canal by using a star-shaped design. Depending on the needed length the surgeon is able to decide using the sleeve or not. All necks are available in three sizes to achieve the total length needed. The use of the instruments and the single step to assemble the system is shown very clearly in the enclosed pictures.
The MRP-Titan components are single-use devices.
Here's an analysis of the provided text regarding the ROTEC MEDIZINTECHNIK GmbH MRP-Titan System, focusing on acceptance criteria and study data.
It's important to note that the provided documentation is a 510(k) summary for a medical device (hip prosthesis components). This type of submission focuses on demonstrating "Substantial Equivalence" to previously marketed devices, rather than comprehensive performance studies as might be seen for novel technologies or AI/software. Therefore, many of the typical AI/software performance study elements requested will not be present.
Based on the provided text, the device itself is a mechanical implant, not an AI/software device. The "acceptance criteria" here refer to the mechanical performance and biocompatibility of the implant, not the accuracy of an algorithm.
Acceptance Criteria and Device Performance (for a Mechanical Implant)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | All main components (Stems, Special Implant for Trochanter, Necks, Locking screw, Screws, Extension sleeves) are made of Ti6Al4V (ASTM F136). The hip head (Biolox® forte) is made of Medical Alumina Al2O3 (ISO 6474). |
| Biocompatibility | Implied by the use of established medical-grade materials (Ti6Al4V, Alumina) and reference to FDA Master File for Biolox® forte, suggesting prior approval and known biocompatibility. The statement "We have reviewed all prior literature on this type of implant device and can not find a substantial body of information on the adverse effects with this device" also serves as a general statement towards safety in this context. |
| Mechanical Strength/Fatigue | Fatigue testing according to ISO 7206-4, -8 demonstrated that the device with 12/14 taper survived more than 5 x 10^6 cycles without any failure while loaded according to ISO 7206. This meets or exceeds the standard's requirements for hip stem fatigue. |
| Sterilization Efficacy | Metal elements and Alumina balls will be shipped in sterile packages by Gamma-Radiation, > 25 kGy, by a process shown and validated in Chapter 15 of the submission. A truthful and accurate statement regarding this process is included. |
| Substantial Equivalence to Predicate(s) | The device "functions in a similar manner as predicted commercially available devices and are equivalent to systems cited in this application (table 2-2 new) especially to Link, Modular Revision Hip Stem, K 955296 or Johnson & Johnson, System S-ROM, K 961 939." This is the primary acceptance criterion for a 510(k) submission, confirming the device is as safe and effective as a legally marketed predicate device. This is explicitly stated in the FDA's clearance letter. The indications for use are also accepted as being equivalent to the predicate devices. |
Study Information (as applicable for a mechanical implant 510(k))
Since this is a 510(k) for a medical device (hip prosthesis components) and not an AI/software device, many of the requested AI-specific study details are not applicable or not present in this type of regulatory submission. The studies described are engineering/biomechanical tests.
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Sample size used for the test set and the data provenance:
- Test Set (for Fatigue Testing): The document indicates "the device with 12/14 taper" was tested. It does not specify the exact number of physical samples tested, but usually, multiple samples would be subjected to fatigue testing to establish reliability.
- Data Provenance: The fatigue testing refers to ISO standards (ISO 7206-4, -8), implying these tests were conducted in a controlled laboratory environment, likely in Germany where the manufacturer is located, or by a certified testing facility adhering to these international standards. The data is prospective, as it's generated specifically for regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical fatigue testing, "ground truth" is not established by human experts in the same way as medical image interpretation. The "ground truth" is defined by the physical properties of the material and the engineering standards (ISO 7206 series) that specify failure criteria and loading conditions. The experts involved would be materials scientists, mechanical engineers, and quality assurance personnel overseeing the testing. Their qualifications would involve expertise in biomechanics, material science, and ISO standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations (e.g., diagnosing a condition from an image). For mechanical testing, the failure criteria are objective (e.g., "without any failure" as reported). The lab conducting the test ensures adherence to the ISO standard.
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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:
- Not applicable. This device is a passive mechanical implant and does not involve AI or human readers for diagnostic interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a passive mechanical implant and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the fatigue testing, the "ground truth" for success is defined by the implant (specifically the 12/14 taper) surviving more than 5 x 10^6 cycles without any failure when loaded according to the specifications of ISO 7206 standards. This is a predetermined, objective engineering standard rather than an expert consensus or pathology.
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The sample size for the training set:
- Not applicable. This device is a physical implant, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for it.
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Manufacturers name: ROTEC MEDIZINTECHNIK GmbH Adress: Am Mühlberg 31 D - 91085 Weisendorf Telephone: *49 - 9135 - 32 15 Contact Person: Dr.-Ing. Ulrich Holzwarth Telephone: *49 - 9135 - 71 03 38
Revised Summary of Safety & Effectiveness Information Supplied as part of the 510 (k) Application for the ROTEC MEDIZINTECHNIK GmbH MRP-Titan System
Proprietary Name: ROTEC, MRP-Titan System
Complete device description:
The patientmatched modular revision hip system MRP-Titan was developed to achieve best fixation of the stem in the femur canal by using a star-shaped design. Depending on the needed length the surgeon is able to decide using the sleeve or not. All necks are available in three sizes to achieve the total length needed. The use of the instruments and the single step to assemble the system is shown very clearly in the enclosed pictures.
The MRP-Titan components are single-use devices.
Identification of all device components, sizes and materials:
| Name | Article No. | Diameter/size | Materials |
|---|---|---|---|
| Stem 200 mm, curved | 61013-03 | 13 mm | Ti6Al4V |
| Stem 200 mm, curved | 61014-03 | 14 mm | Ti6Al4V |
| Stem 200 mm, curved | 61015-03 | 15 mm | Ti6Al4V |
| Stem 200 mm, curved | 61016-03 | 16 mm | Ti6Al4V |
| Stem 200 mm, curved | 61017-03 | 17 mm | Ti6Al4V |
| Stem 200 mm, curved | 61018-03 | 18 mm | Ti6Al4V |
| Stem 200 mm, curved | 61019-03 | 19 mm | Ti6Al4V |
| Stem 200 mm, curved | 61020-03 | 20 mm | Ti6Al4V |
| Stem 200 mm, curved | 61021-03 | 21 mm | Ti6Al4V |
| Stem 200 mm, curved | 61022-03 | 22 mm | Ti6Al4V |
| Stem 140 mm, straight | 61013-01 | 13 mm | Ti6Al4V |
| Stem 140 mm, straight | 61014-01 | 14 mm | Ti6Al4V |
| Stem 140 mm, straight | 61015-01 | 15 mm | Ti6Al4V |
| Stem 140 mm, straight | 61016-01 | 16 mm | Ti6Al4V |
| Stem 140 mm, straight | 61017-01 | 17 mm | Ti6Al4V |
| Stem 140 mm, straight | 61018-01 | 18 mm | Ti6Al4V |
| Stem 140 mm, straight | 61019-01 | 19 mm | Ti6Al4V |
| Stem 140 mm, straight | 61020-01 | 20 mm | Ti6Al4V |
| Stem 140 mm, straight | 61021-01 | 21 mm | Ti6Al4V |
| Stem 140 mm, straight | 61022-01 | 22 mm | Ti6Al4V |
| Special Implant for Trochanter | 61000-04 | small | Ti6Al4V |
| Special Implant for Trochanter | 61000-05 | large | Ti6Al4V |
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| Neck with Trochanter | 61000-11 | K | Ti6Al4V |
|---|---|---|---|
| Neck with Trochanter | 61000-12 | M | Ti6Al4V |
| Neck with Trochanter | 61000-13 | L | Ti6Al4V |
| Locking screw | 61000-06 | Ti6Al4V | |
| Neck without fin | 61002-11 | K | Ti6Al4V |
| Neck without fin | 61002-12 | M | Ti6Al4V |
| Neck without fin | 61002-13 | L | Ti6Al4V |
| Neck with fin | 61001-11 | K | Ti6Al4V |
| Neck with fin | 61001-12 | M | Ti6Al4V |
| Neck with fin | 61001-13 | L | Ti6Al4V |
| Screw | 60901-04 | small | Titanium |
| Screw | 60901-07 | large | Titanium |
| Extension sleeve | 61016-04 | 16 mm | Ti6Al4V |
| Extension sleeve | 61018-04 | 18 mm | Ti6Al4V |
| Extension sleeve | 61020-04 | 20 mm | Ti6Al4V |
| Extension sleeve | 61022-04 | 22 mm | Ti6Al4V |
Included are Confidential Detailed Drawings of the MRP-Titan System
Implant Materials: Medical Alloy Ti6Al4V, ASTM F136 Biolox® forte, (Medical Alumina Al2O3), ISO 6474
Statement of Safety: We have reviewed all prior literature on this type of implant device and can not find a substantial body of information on the adverse effects with this device.
Potential Risks:
The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
- Reaction to bone cement Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the ioint Dislocation Metal sensitivity
- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Delayed wound healing
Substantial equivalency: ROTEC MRP-Titan functions in a similar manner as predicted commercially available devices and are equivalent to systems cited in this application (table 2-2 new) especially to Link, Modular Revision Hip Stem, K 955296 or Johnson & Johnson, System S-ROM, K 961 939.
Indications for use: The MRP-Titan system is intended to be used as the proximal part of a hip stem arthoplasty. The indications for use of the MRP-Titan system are revision operations and femur fractures of primary hip operated patients as well as tumour situations at the femur.
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The MRP-Titan System is designed and proven to match with the following hip head: Bioloxforte 12/14, manufactured by Ceramtec CE 0044, FDA Master File. Fatigue testing acc. to ISO 7206-4, -8 has demonstrated that the device with 12/14 taper survived more than 5 x 10 cycles without any failure while loaded acc. to ISO 7206.
Sterilization: The MRP-Titan system metal elements and Alumina balls will be shipped in sterile package by Gamma-Radiation, > 25 kGy, by the process shown and validated in chapter 15, truthful and accurate statement is included.
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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
JAN 21 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. -Ing. Ulrich Holzwarth Head of Quality Assurance ROTEC MEDIZINTECHNIK GmbH Am Muhlberg 31 D-91084 Weisendorf Germany
Re: K992403 Trade Name: MRP-Titan Regulatory Class: II Product Code: LZO Dated: November 12, 1999 Received: November 15, 1999
Dear Dr. -Ing. Ulrich Holzwarth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2- Dr. -Ing. Ulrich Holzwarth
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Henrici Jagan
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K992403
Device Name: MRP-Titan
Indications for use:
- Primary and revision arthroplasty: Revision of primary hip stem prostheses ●
- Fractures of the proximal femur ●
- Tumor situation of the proximal femur ●
- Reconstructions of the upper area of the proximal femur after both primary hip ● operation or traumafracture
- Recovery of leg-lengthening ●
- Improving antetorsion after failed primary hip stem operation ●
Date: 99-11-05
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rumell Lyons
(Division Sign-Off) Division of General Restorative Device 510(k) Number _
Prescription Use X
OR
Over-The=Counter Use
1-3
(Optional Format 1-2-96)
CE
19
N/A