MRP-TITAN

K992403 · Rotec Medizintechnik GmbH · LZO · Jan 21, 2000 · Orthopedic

Device Facts

Record IDK992403
Device NameMRP-TITAN
ApplicantRotec Medizintechnik GmbH
Product CodeLZO · Orthopedic
Decision DateJan 21, 2000
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3353
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

MRP-Titan is a modular revision hip system designed for femoral canal fixation via a star-shaped stem design. System components include curved or straight stems, necks (with/without fins/trochanter), locking screws, and extension sleeves. Surgeons select components based on required length and anatomical needs. Used in clinical settings by orthopedic surgeons during revision hip arthroplasty, fracture repair, or tumor resection. The device acts as the proximal portion of a hip stem prosthesis, providing structural support and fixation within the femur. It is compatible with Biolox forte hip heads. Benefits include restoration of hip function, leg length, and antetorsion. Components are single-use and provided sterile.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, specifically fatigue testing conducted in accordance with ISO 7206-4 and ISO 7206-8. The device with a 12/14 taper successfully survived more than 5 x 10^6 cycles without failure under specified loading conditions.

Technological Characteristics

Modular hip system components made of Ti6Al4V (ASTM F136) and Titanium. Features a star-shaped stem design for femoral canal fixation. Employs a 12/14 taper for hip head connection. Sterilized via Gamma-Radiation (> 25 kGy).

Indications for Use

Indicated for primary and revision hip arthroplasty, revision of primary hip stem prostheses, proximal femur fractures, proximal femur tumors, reconstruction of the upper proximal femur following primary hip surgery or trauma, leg-lengthening, and improving antetorsion after failed primary hip stem surgery.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K992403 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 | {1}------------------------------------------------ | 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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
Innolitics
510(k) Summary
Decision Summary
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