(210 days)
Not Found
Not Found
No
The device description focuses on a mechanical and electromagnetic lengthening mechanism, with no mention of AI or ML for decision-making, control, or analysis.
Yes
Explanation: The device is a limb salvage prosthesis that is implanted to replace resected bone, restoring function and aiding in recovery from severe conditions like trauma, arthropathy, and oncology indications, which are therapeutic actions.
No
The device description clearly states it is a prosthesis for limb salvage surgery that uses an external electromagnetic transmitter to lengthen the implant, indicating a therapeutic or reconstructive function rather than a diagnostic one.
No
The device description clearly outlines multiple hardware components including a prosthesis kit (Distal Hinge Femur, Tibial Base, Axial Bushing, Axial Pin), an external electro-magnetic transmitter, and an internal lengthening mechanism with tubes, a spring, and a locking mechanism. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The REPIPHYSIS™ Prosthesis is an implantable device used for limb salvage surgery. It is a physical prosthesis designed to replace bone and joint structures.
- Intended Use: The intended use describes surgical procedures for treating severe arthropathy, trauma, revision knee arthroplasties, and oncology indications. This involves surgical intervention and implantation, not the analysis of biological specimens.
- Mechanism of Action: The device works through mechanical expansion activated by an external electromagnetic field, not through biochemical or biological reactions with patient samples.
The information provided clearly describes a surgical implant and its mechanism of action, which is entirely external to the analysis of biological samples.
N/A
Intended Use / Indications for Use
The REPIPHYSIS™ prosthesis is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions:
-
- patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
-
- surgical intervention for severe trauma, revision knee arthroplasties, and/or oncology indications.
-
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)
The REPIPHYSIS™ Limb Salvage System components are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
KRO
Device Description
Malignant bone tumors in children often occur in the long bones, at or near the joints (shoulder, hip, and knee). Removal of the tumor often requires removal of part or the entire joint. Because the joint is where the growth of the limb occurs, one of the major problems in saving the limb in young growing children involves the ability to maintain equal lengths of the operated arm or leg with the unoperated side. Many attempts have been made to design a prosthesis, which could be easily expanded either without surgerv or through a very minor surgical procedure. Most of these designs have had mechanical difficulty or the lengthening procedure becomes a major surgical effort. The REPIPHYSISTM Limb Salvage System the complications that are known to occur with repeated operations. Once the prosthesis is fully implanted, the noninvasive lengthening of the prosthesis is activated by an external electromagnetic field.
The REPIPHYSISTM Limb Salvage System (Wright Medical Technology, Arlington, Tennessee) was previously named the Phenix Growing Prosthesis (Phenix Medical, Paris, France). The Phenix Growing Prosthesis was designed in France in the early 1980s. More than 100 patients have been treated with Phenix Growing Prosthesis in the last 20 years.
IMPLANT DESCRIPTION
The REPIPHYSIS™ Prosthesis is custom assembled for each patient. The REPIPHYSIS™ is implanted the same way as any other joint replacement device using non-allergic, standard materials that have been tested in biological situations. The REPIPHYSIS™ Limb Salvage Prosthesis Kit consists of the following components:
Distal Hinge Femur
The femoral housing is the main body of the distal hinge femoral portion of the implant. The most distal end of the femoral housing forms the outer components of the femoraltibial hinge. It internally houses the following various components of the expansion mechanism.
Tibial Base
The tibial base provides fixation to the proximal tibia. It consists of a cylindrical stem portion, which extends into the proximal tibial medullary canal. The more proximal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are two small tabs that protrude down into the tibial plateau for rotational stability. On the top of this plate is the inner component of the femoral-tibial hinge mechanism.
Axial Bushing
The axial bushing goes inside the center hinge portion of the tibial base. This bushing is held in place by the two outer hinge features of the femoral housing. This bushing supplies the wear surface through which forces are transmitted between the femoral and tibial components and around which rotation occurs.
Axial Pin
The axial pin is introduced through the outer hinge portion of the distal femoral housing and into the axial bushing, which is contained in the center hinge portion of the tibial base. It extends through the other side of the outer hinge mechanism of the femoral housing. The axial pin mates with the outer hinge portions of the distal femoral housing and the inner diameter of the axial bushing. The axial pin is the pivot for the femoraltibial hinge mechanism.
INSTRUMENT DESCRIPTION
The REPIPHYSIS™ prosthesis is implanted the same way as any other Limb Salvage System.
In addition the REPIPHYSIS™ prosthesis uses an external electro-magnetic transmitter to activate the implant lengthening mechanism. The REPIPHYSIS Transmitter Unit operates by producing an electrical current in an inductor coil, which in turn generates a strong electro-magnetic field in the vicinity of the coil. When an electrically conductive material is placed within this electro-magnetic field, an electrical current is induced in the conductive material. If the proper conditions are established, this electrical current is sufficient to cause significant heating in this material.
OPERATION DESCRIPTION
The REPIPHYSIS™ prosthesis is implanted the same way as any other Limb Salvage System.
The lengthening technique for the REPIPHY SIS™ prosthesis is briefly described below:
The REPIPHYSIS™ prosthesis consists of two tubes with a spring mechanism contained in the larger tube (Exhibit 11: Photo of the Femoral Housing and sub-components). It is maintained compressed by a polyacetal locking mechanism. One tube is connected to the stem of the implant, and the second comprises the hinge portion of the hinge prosthesis. The uninvolved side of the joint is minimally resurfaced with a press-fit stem to attempt to preserve function of the non-involved growth plate. Expansion is achieved via exposure to an external electromagnetic field around the extremity. The coil transmits an electromagnetic field around the implant in the vicinity of the v-shaped flange of the spring housing tube. This generates an electrical current within the flange of the spring housing tube and is focused on the receiving antennae within the implant itself. This antenna is heated by the electromagnetic field. The heated element softens the surrounding polyacetal locking mechanism, which allows the spring expansion. The spring expansion pushes the two tubes apart from each other, thus lengthening the overall length of the leg. As skeletal growth occurs on the contralateral side, a discrepancy in the overall length of the two legs occurs. Follow-up scanograms quantify the discrepancy. Once a .5- to 1.0-cm discrepancy has occurred, the patient is taken to the fluoroscopy suite and remains awake without sedation or anesthesia. The receiving antennae within the implant are identified under fluoroscopy guidance and the skin is marked. The electromagnetic device is then applied over the receiving antennae, and the patient activates the device for a period of approximately 15 seconds. A radiograph using magnification markers is then obtained of the level of the spring to determine how much lengthening has occurred. Once the desired amount of lengthening (typically 0.5 to 1cm) is achieved, the process is stopped. One or two activation processes are required to achieve the desired lengthening. The procedure is halted if the patient experiences any discomfort or anxiety. Follow-up radiographs are scheduled at 2 to 3-month intervals until the next lengthening is required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur and/or proximal tibia
Indicated Patient Age Range
Not Found
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)
Not Found
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.
Not Found
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
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" made up of three black triangles, followed by the company name in bold, sans-serif font. Below the company name is the address "5677 Airline Road, Arlington, TN 38002" and the phone number "901-867-9971".
K021489
Page 1 of 4
DEC (1 4 2002
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the REPIPHYSIS™ Limb Salvage System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | May 7, 2002 |
| Contact Person: | Ehab M. Esmail |
| Manager, Regulatory Affairs | |
| Proprietary Name: | REPIPHYSIS™ Limb Salvage System |
| Common Name: | Limb Salvage System |
| Classification Name and Reference: | 21 CFR 888.3510 Prosthesis, Knee, Femorotibial, |
| Constrained, Cemented, Metal/Polymer – Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/KRO |
DEVICE INFORMATION
A. INTENDED USE
The REPIPHYSIS™ prosthesis is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions:
-
- patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
-
- surgical intervention for severe trauma, revision knee arthroplasties, and/or oncology indications.
-
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)
The REPIPHYSIS™ Limb Salvage System components are for single use only.
Image /page/0/Picture/13 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, serif typeface. Below the name is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The overall design is simple and professional.
Image /page/0/Picture/14 description: The image shows a black and white drawing of the Earth. The Earth is partially illuminated, with the continents of Australia and Asia visible. There is a curved line above the Earth, which may represent the atmosphere or a satellite orbit.
1
K02148a
Page 2 of 4
B. DEVICE DESCRIPTION
BACKROUND DESCRIPTION
Malignant bone tumors in children often occur in the long bones, at or near the joints (shoulder, hip, and knee). Removal of the tumor often requires removal of part or the entire joint. Because the joint is where the growth of the limb occurs, one of the major problems in saving the limb in young growing children involves the ability to maintain equal lengths of the operated arm or leg with the unoperated side. Many attempts have been made to design a prosthesis, which could be easily expanded either without surgerv or through a very minor surgical procedure. Most of these designs have had mechanical difficulty or the lengthening procedure becomes a major surgical effort. The REPIPHYSISTM Limb Salvage System the complications that are known to occur with repeated operations. Once the prosthesis is fully implanted, the noninvasive lengthening of the prosthesis is activated by an external electromagnetic field.
The REPIPHYSISTM Limb Salvage System (Wright Medical Technology, Arlington, Tennessee) was previously named the Phenix Growing Prosthesis (Phenix Medical, Paris, France). The Phenix Growing Prosthesis was designed in France in the early 1980s. More than 100 patients have been treated with Phenix Growing Prosthesis in the last 20 years.
IMPLANT DESCRIPTION
The REPIPHYSIS™ Prosthesis is custom assembled for each patient. The REPIPHYSIS™ is implanted the same way as any other joint replacement device using non-allergic, standard materials that have been tested in biological situations. The REPIPHYSIS™ Limb Salvage Prosthesis Kit consists of the following components:
Distal Hinge Femur
The femoral housing is the main body of the distal hinge femoral portion of the implant. The most distal end of the femoral housing forms the outer components of the femoraltibial hinge. It internally houses the following various components of the expansion mechanism.
Tibial Base
The tibial base provides fixation to the proximal tibia. It consists of a cylindrical stem portion, which extends into the proximal tibial medullary canal. The more proximal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are two small tabs that protrude down into the tibial plateau for rotational stability. On the top of this plate is the inner component of the femoral-tibial hinge mechanism.
Axial Bushing
The axial bushing goes inside the center hinge portion of the tibial base. This bushing is held in place by the two outer hinge features of the femoral housing. This bushing supplies the wear surface through which forces are transmitted between the femoral and tibial components and around which rotation occurs.
Image /page/1/Picture/13 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, underlined by a thin line.
Image /page/1/Picture/14 description: The image shows a black and white drawing of a celestial body, possibly a planet or moon. The surface has a rough texture with dark and light patches, suggesting craters or other geological features. A curved line at the top indicates the edge of the sphere, and a small, dark shape is visible at the bottom, possibly a shadow or another object.
-510(K) SUMMARY
2
Axial Pin
The axial pin is introduced through the outer hinge portion of the distal femoral housing and into the axial bushing, which is contained in the center hinge portion of the tibial base. It extends through the other side of the outer hinge mechanism of the femoral housing. The axial pin mates with the outer hinge portions of the distal femoral housing and the inner diameter of the axial bushing. The axial pin is the pivot for the femoraltibial hinge mechanism.
INSTRUMENT DESCRIPTION
The REPIPHYSIS™ prosthesis is implanted the same way as any other Limb Salvage System.
In addition the REPIPHYSIS™ prosthesis uses an external electro-magnetic transmitter to activate the implant lengthening mechanism. The REPIPHYSIS Transmitter Unit operates by producing an electrical current in an inductor coil, which in turn generates a strong electro-magnetic field in the vicinity of the coil. When an electrically conductive material is placed within this electro-magnetic field, an electrical current is induced in the conductive material. If the proper conditions are established, this electrical current is sufficient to cause significant heating in this material.
OPERATION DESCRIPTION
The REPIPHYSIS™ prosthesis is implanted the same way as any other Limb Salvage System.
The lengthening technique for the REPIPH YSIS™ prosthesis is briefly described below:
The REPIPHYSIS™ prosthesis consists of two tubes with a spring mechanism contained in the larger tube (Exhibit 11: Photo of the Femoral Housing and sub-components). It is maintained compressed by a polyacetal locking mechanism. One tube is connected to the stem of the implant, and the second comprises the hinge portion of the hinge prosthesis. The uninvolved side of the joint is minimally resurfaced with a press-fit stem to attempt to preserve function of the non-involved growth plate. Expansion is achieved via exposure to an external electromagnetic field around the extremity. The coil transmits an electromagnetic field around the implant in the vicinity of the v-shaped flange of the spring housing tube. This generates an electrical current within the flange of the spring housing tube and is focused on the receiving antennae within the implant itself. This antenna is heated by the electromagnetic field. The heated element softens the surrounding polyacetal locking mechanism, which allows the spring expansion. The spring expansion pushes the two tubes apart from each other, thus lengthening the overall length of the leg. As skeletal growth occurs on the contralateral side, a discrepancy in the overall length of the two legs occurs. Follow-up scanograms quantify the discrepancy. Once a .5- to 1.0-cm discrepancy has occurred, the patient is taken to the fluoroscopy suite and remains awake without sedation or anesthesia. The receiving antennae within the implant are identified under fluoroscopy guidance and the skin is marked. The electromagnetic device is then applied over the receiving antennae, and the patient
Image /page/2/Picture/10 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. A thin line underlines the text "MEDICAL TECHNOLOGY, INC."
Image /page/2/Picture/11 description: The image shows a black and white drawing of a planet. The planet has a rough, textured surface with dark and light areas. There is a ring around the planet, and a small object is visible below it. The drawing is simple and lacks detail, giving it a somewhat abstract appearance.
3
K021489
Page 4 of 4
activates the device for a period of approximately 15 seconds. A radiograph using magnification markers is then obtained of the level of the spring to determine how much lengthening has occurred. Once the desired amount of lengthening (typically 0.5 to 1cm) is achieved, the process is stopped. One or two activation processes are required to achieve the desired lengthening. The procedure is halted if the patient experiences any discomfort or anxiety. Follow-up radiographs are scheduled at 2 to 3-month intervals until the next lengthening is required.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interface, and design features of REPIPHYSISTM Limb Salvage System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the REPIPHYSIS™ Limb Salvage System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
Image /page/3/Picture/4 description: The image shows the logo for Wright Medical Technology, Inc. The logo features the word "WRIGHT" in large, bold, sans-serif font. Above the word "WRIGHT" is a stylized "W" symbol. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller font.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
DEC 04 2002
200 Cornorate Roulevard
Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road · Arlington, Tennessee 38002
Re: K021489
Trade/Device Name: REPIPHYSIS™ Limb Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: November 18, 2002 Received: November 19, 2002
Dear Mr. Esmail:
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 mav, 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 (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 – Mr. Ehab M. Esmail
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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K021489
Page 1 of 1
REPIPHYSIS™ Limb Salvage System
INDICATIONS STATEMENT
Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions:
-
- patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
-
- surgical intervention for severe trauma, revision knee arthroplasties, and/or oncology indications.
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone 3. tumors)
for Mark A. Millburn
(Division Sign-Off)
Division of General. Restorative and Neurological Devices
510(k) Number K031489
Image /page/6/Picture/11 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.
Image /page/6/Picture/12 description: The image shows a black and white photograph of a person's head and shoulders. The person appears to be wearing a dark garment, and their face is partially obscured by shadows. The background is blurred, but it seems to be an indoor setting. The image has a grainy texture, which suggests that it may have been taken with an older camera or that it has been digitally altered.
-INDICATIONS STATEMENT