(219 days)
The MRS-Titan system is intended to be used as the acetabular part of a hip arthroplasty. The indications for use of the MRS-Titan system are revision operations and fractures of primary hip operated patients, especially with large bone defects in the acetabulum, as well as tumour situations at the acetabulum.
Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid arthritis, post traumatic arthritis.
Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other procedure.
Clinical management problem solve arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated deficiencies of the acetabulum.
The patientmatched modular revision acetabular system MRS-Titan was developed to achieve best fixation of the cup in the acetabulum by using a cementless bone fixation technique. Depending on the needed diameter the surgeon is able to decide the size between Ø 48 mm and Ø 64 mm in 4 mm steps. All diameters are able to be used either with a caudal hook and a strap, two straps or only with two straps. In general the caudal hook is designed to fix the original center of rotation because generally the use of MRS-Titan is intended after the second, third or fourth revision operation at the natural acetabulum. Typically this condition shows a very bad boney situation. So this device allows the surgeon to create a good remodelling of the acetabular bone as well as a good mechanical stabilisation of the cup. In comparison to other systems having received the SEletter the straps are not fixed in one angle, rotation allows to adapt the straps in best angle situation the patient needs. The MRS components are single-use devices.
The provided text describes the ROTEC MEDIZINTECHNIK GmbH MRS-Titan System, an acetabular revision system. However, it does not contain specific acceptance criteria or a study designed to prove the device meets such criteria in a way that would allow for the detailed answers requested. Instead, the document is a summary of safety and effectiveness information for a 510(k) application, focusing on substantial equivalence to predicate devices and mechanical testing within established standards.
Therefore, many of the requested fields cannot be answered directly from the provided text.
Here's an attempt to answer based on the available information, noting where details are missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Axial and Lever Arm Disassembly) | Axial and lever arm disassembling (ASTM F 1820) testing results showed that there is enough safety regarding the lever arm disassembling force which is double as high as the load of an average human bending. Load values reported: Diameter 48 mm: 1156 N, Diameter 64 mm: 1460 N. |
| Fatigue Life (Hip Stem Compatibility) | Fatigue testing - using the MRS-Titan while testing hip stems - according to ISO 7206-4 has demonstrated that the device survived 5 x 10^6 cycles without failure while loaded according to ISO 7206. (This criteria applies to the system with a compatible hip head, not solely the MRS-Titan). |
| Biocompatibility of Materials | Approved medical-grade materials: Ti6Al4V (accord. to ASTM F 136), Ti1 CP Titanium (accord. to ASTM F 67), UHMWPE. The statement implicitly accepts these materials as suitable for implantation. |
| Sterilization Efficacy | The MRS-Titan system metal and Polyethylene will be shipped in sterile package by Gamma-Radiation > 25 kGy. (Acceptance criteria implicitly met by using a validated sterilization method). |
| Substantial Equivalence (Overall Function & Safety) | "MRS-Titan functions in a similar manner as predicted commercially available devices and are equivalent to systems cited in this application... MRS-Titan is substantially equivalent to other acetabular devices on the market in our design and intended function." (This is the primary acceptance criteria for a 510(k) submission, not a performance metric per se, but an overarching regulatory finding based on comparison to predicate devices and supporting data like mechanical testing). |
| Absence of Substantial Adverse Effects in Prior Literature | "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." (This is a statement regarding the review of existing knowledge, implying that no known adverse effects contradict its safety for market introduction, rather than a direct performance metric). |
| Potential Risks (Identified and Managed) | Potential risks associated with hip replacement devices are acknowledged and listed (e.g., reaction to bone cement, fracture, loosening, infection, etc.). The implication is that these risks are similar to predicate devices and are deemed acceptable given the benefits and design. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any specific clinical test set. The mechanical tests (ASTM F 1820 and ISO 7206-4) would have involved a sample of the manufactured devices, but the exact number of units tested is not stated. These are laboratory tests, not clinical data.
- Data Provenance: Not specified. The company is based in Germany, so it's plausible the testing was conducted there or by affiliated labs. The data is from in vitro mechanical testing, not human clinical trials (retrospective or prospective).
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 question is not applicable. The device's performance was evaluated through in vitro mechanical testing against established standards (ASTM F 1820, ISO 7206). There was no "ground truth" derived from expert consensus on clinical cases. The "experts" involved would be engineers and material scientists conducting the tests and interpreting the results against the standards. Their qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to human review of clinical data, often involving multiple readers and a consensus or adjudication process. The provided document concerns in vitro mechanical testing and a regulatory submission based on substantial equivalence.
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
- Not applicable. This device is a physical implant (acetabular revision system), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's mechanical performance was adherence to recognized international standards for orthopedic implants (ASTM F 1820 for disassembling forces and ISO 7206-4 for fatigue testing) and the use of biocompatible materials. The core of the 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices rather than proving novel clinical efficacy through outcomes data.
8. The sample size for the training set
- Not applicable. This device is a physical implant, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process of such devices involves extensive quality control and verification, but not "training data."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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Manufacturers name: ROTEC MEDIZINTECHNIK GmbH Adress: Am Mühlberg 31 D - 91085 Weisendorf FEB 1 8 2000 Telephone: *49 – 9135 – 32 15 Contact Person: Dr.-Ing. Ulrich Holzwarth Telephone: *49 - 9135 - 71 06 38
Revised Summary of Safety & Effectiveness Information Supplied as part of the 510 (k) Application for the ROTEC MEDIZINTECHNIK GmbH MRS-Titan System, K 992359
Complete device description:
The patientmatched modular revision acetabular system MRS-Titan was developed to achieve best fixation of the cup in the acetabulum by using a cementless bone fixation technique. Depending on the needed diameter the surgeon is able to decide the size between Ø 48 mm and Ø 64 mm in 4 mm steps. All diameters are able to be used either with a caudal hook and a strap, two straps or only with two straps. In general the caudal hook is designed to fix the original center of rotation because generally the use of MRS-Titan is intended after the second, third or fourth revision operation at the natural acetabulum. Typically this condition shows a very bad boney situation. So this device allows the surgeon to create a good remodelling of the acetabular bone as well as a good mechanical stabilisation of the cup. In comparison to other systems having received the SEletter the straps are not fixed in one angle, rotation allows to adapt the straps in best angle situation the patient needs.
The MRS components are single-use devices Identification of all device components, sizes and materials:
| Name | Article No. | Diameter/size | Material |
|---|---|---|---|
| Spherical Cup | 57348-01 | 48 | Ti6Al4V |
| Spherical Cup | 57352-01 | 52 | Ti6Al4V |
| Spherical Cup | 57356-01 | 56 | Ti6Al4V |
| Spherical Cup | 57360-01 | 60 | Ti6Al4V |
| Spherical Cup | 57364-01 | 64 | Ti6Al4V |
| Stayhook caudal | 57248-01 | 48 | TiRT12 |
| Stayhook caudal | 57252-01 | 52 | TiRT12 |
| Stayhook caudal | 57256-01 | 56 | TiRT12 |
| Stayhook caudal | 57260-01 | 60 | TiRT12 |
| Stayhook caudal | 57264-01 | 64 | TiRT12 |
| Staystrap cranial 35 mm | 57248-22 | 48 | TiRT12 |
| Staystrap cranial 35 mm | 57252-22 | 52 | TiRT12 |
| Staystrap cranial 35 mm | 57256-22 | 56 | TiRT12 |
| Staystrap cranial 35 mm | 57260-22 | 60 | TiRT12 |
| Staystrap cranial 35 mm | 57264-22 | 64 | TiRT12 |
| Staystrap cranial 60 mm | 57248-21 | 48 | TiRT12 |
| Staystrap cranial 60 mm | 57252-21 | 52 | TiRT12 |
| Staystrap cranial 60 mm | 57256-21 | 56 | TiRT12 |
| Staystrap cranial 60 mm | 57260-21 | 60 | TiRT12 |
| Staystrap cranial 60 mm | 57264-21 | 64 | TiRT12 |
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| Name | Article No. | Diameter/size | Material |
|---|---|---|---|
| Countersunk screw | 57348-03 | M4 x 9,5 | Ti6Al4V |
| Countersunk screw | 57348-08 | M4 x 12,5 | Ti6Al4V |
| Countersunk screw | 57348-28 | M4 x 15,5 | Ti6Al4V |
| MC-PE-Insert with snapring | 55148-02 | 48 x 32 | UHMWPE |
| MC-PE-Insert with snapring | 55152-02 | 52 x 32 | UHMWPE |
| MC-PE-Insert with snapring | 55156-02 | 56 x 32 | UHMWPE |
| MC-PE-Insert with snapring | 55160-02 | 60 x 32 | UHMWPE |
| MC-PE-Insert with snapring | 55164-02 | 64 x 32 | UHMWPE |
| MC-PE-Insert with snapring | 55148-12 | 48 x 28 | UHMWPE |
| MC-PE-Insert with snapring | 55152-12 | 52 x 28 | UHMWPE |
| MC-PE-Insert with snapring | 55156-12 | 56 x 28 | UHMWPE |
| MC-PE-Insert with snapring | 55160-12 | 60 x 28 | UHMWPE |
| MC-PE-Insert with snapring | 55164-12 | 64 x 28 | UHMWPE |
| Spongiosascrew | 51265-20 | 6,5 x 20 | Ti6Al4V |
| Spongiosascrew | 51265-25 | 6,5 x 25 | Ti6Al4V |
| Spongiosascrew | 51265-30 | 6,5 x 30 | Ti6Al4V |
| Spongiosascrew | 51265-35 | 6,5 x 35 | Ti6Al4V |
| Spongiosascrew | 51265-40 | 6,5 x 40 | Ti6Al4V |
| Spongiosascrew | 51265-45 | 6,5 x 45 | Ti6Al4V |
| Spongiosascrew | 51265-50 | 6,5 x 50 | Ti6Al4V |
| Spongiosascrew | 51265-55 | 6,5 x 55 | Ti6Al4V |
| Spongiosascrew | 51265-60 | 6,5 x 60 | Ti6Al4V |
Included are Confidential Detailed Drawings of the MRS-Titan System
Implant Materials: Medical Alloy Ti6Al4V, accord. to ASTM F 136 Ti1, CP Titanium for medical application, accord. to ASTM F 67
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.
Axial and lever arm disassembling (ASTM F 1820) testing results (see item 3 above) showed that there is enough safety regarding the lever arm disassembling force which is double as high as the load of an average human bending. This value covers all diameters and is explained for the smallest and the biggest version in item no. 3. Load values are: Diameter 48 mm: 1156 N and diameter 64 mm: 1460 N.
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 joint Dislocation Metal sensivitv
- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Delayed wound healing
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Substantial equivalency: ROTEC MRS-Titan functions in a similar manner as predicted commercially available devices and are equivalent to systems cited in this application. (July 1ª 1999 and this one). MRS-Titan is substantially equivalent to other acetabular devices on the market in our design and intended function. The following devices are predicated to the MRS-Titan: Osteonics restauration gap, K963946. Biomeds modular acetabular reconstructive system. K 911718, Biomeds recovery protrusio cup, K 971890, Osteonics modular acetabular cup, microstructured version, K 963946, Biomeds modular protrusio cup. K 990032 (here are several different options with the use of a hook and straps).
Indications for use: The MRS-Titan system is intended to be used as the acetabular part of a hip arthroplasty. The indications for use of the MRS-Titan system are revision operations and fractures of primary hip operated patients, especially with large bone defects in the acetabulum, as well as tumour situations at the acetabulum.
The MRS-Titan System is designed and proven to match with the following hip head: Biolox® forte 12/14, manufactured by Ceramtec CE 0044, FDA Master File, MAF 746. Fatigue testing - using the MRS-Titan while testing hip stems - according to ISO 7206-4 has demonstrated that the device with survived 5 x 10 cycles without failure while loaded according to ISO 7206.
Sterilization: The MRS-Titan system metal and Polyethylene will be shipped in sterile package by Gamma-Radiation > 25 kGy, Statement of Truth and Accuracy 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Dr. Ing Ulrich Holzwarth Head of Quality Assurance Rotec Medizintechnik Am Muhlberg 31 D-91084 Weisendorf Germany
Re: K992359 Trade Name: MRS Titan Regulatory Class: II Product Code: LZO Dated: December 10, 1999 Received: January 28, 2000
Dear Dr. 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 (OS) 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.
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.
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Page 2 – Dr. Ing Ulrich Holzwarth
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,
Néil R.P. Ogden
James E. Dillard II 25 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): K 992359
Device Name: MRS-Titan
Indications for use:
- Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid . arthritis, post traumatic arthritis.
- Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other ● procedure.
- Clinical management problem solve arthrodesis or alternative techniques are less likely to . achieve satisfactory results.
- Bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated deficiencies of the acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | NKO Sw JZD |
| Division of General Restorative Devices | |
| 510(k) Number | K992359 |
| Prescription Use | X |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)
N/A