(227 days)
Not Found
No
The device description focuses on mechanical expansion and a rotating hinge design. There is no mention of AI, ML, image processing, or data-driven decision-making in the provided text.
Yes
The device is a prosthesis intended to reconstruct large bone defects and allow for expansion as a patient grows, which directly addresses a medical condition (bone defects, trauma, arthritis, etc.) and improves anatomical function.
No
The device is a prosthetic implant used for reconstruction of bone defects, not for diagnosing conditions.
No
The device description clearly states it is a "Distal Femoral Growing Prosthesis System" which is an implantable hardware device used for bone reconstruction. It describes mechanical expansion and surgical implantation, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this is a Distal Femoral Growing Prosthesis, which is an implantable medical device used to reconstruct bone defects in pediatric patients. It is surgically implanted into the body.
- Intended Use: The intended use describes the conditions for which the prosthesis is used (oncology, trauma, etc.) and the anatomical site (distal femur and/or proximal tibia). This is a description of a surgical intervention, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Distal Femoral Growing Prosthesis System offers a treatment option for patients requiring distal femoral replacement who have not achieved full skeletal maturity (open epiphysis). The devices are single use implants.
The Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:
- . Oncology indications
- Severe trauma .
- Noninflammatory degenerative joint disease including osteoarthritis .
- Correction of functional deformity ◆
- Rheumatoid arthritis ●
- Revision procedures where other treatments or devices have failed .
The devices are single use implants and intended only for implantation with bone cement.
Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.
Product codes (comma separated list FDA assigned to the subject device)
87KRO
Device Description
The Distal Femoral Growing Prosthesis System provides a means to reconstruct large bone defects resulting from bone resection in skeletally immature patients. The device can be expanded as a patient grows so that leg-length equality can be achieved. The device utilizes a rotating hinge design. The expansion process is mechanical and is conducted with subsequent minimally invasive procedures following the initial implantation surgery.
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
pediatric who have not achieved full skeletal maturity (open epiphysis)
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. Single-axis and multi-axis life cycle testing of the Distal Femoral Growing Prosthesis was conducted to verify that the expansion feature of the device will not cause the subject component to collapse/retract before, after and during physiological loading. All specimens tested ran out without evidence of collapse of the device. Fatigue testing was also conducted on the Distal Femoral Growing Prosthesis crossover bearing component. All test specimens withstood physiological loading as compared to the predicate device.
Clinical Testing: Clinical testing was not required for this submission.
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.
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
510(k) Summary of Safety and Effectiveness
FEB 2 2 2013
| Proprietary Name: | Distal Femoral Growing Prosthesis System |
|---|---|
| Common Name: | Knee Replacement Prosthesis and Modular |
| Rotating Hinge Knee | |
| Classification Name and Reference: | Prosthesis, Knee, Femorotibial, Constrained, |
| Cemented, Metal/Polymer | |
| 21 CFR § 888.3510 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87KRO: Knee Joint Femorotibial Metal/Polymer |
| Constrained Cemented Prosthesis | |
| For Information Contact: | Christie Pencinger |
| Regulatory Affairs Associate | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365; Fax (201)831-3365 | |
| Legally Marketed Devices to Which | |
| Substantial Equivalence Is Claimed: | K020381: Expandable Knee |
| K023087: Global Modular Replacement System | |
| (GMRS) | |
| K965164: Howmedica Modular Replacement | |
| System-Proximal Femur | |
| Date Prepared: | November 26, 2012 |
Description
The Distal Femoral Growing Prosthesis System provides a means to reconstruct large bone defects resulting from bone resection in skeletally immature patients. The device can be expanded as a patient grows so that leg-length equality can be achieved. The device utilizes a rotating hinge design. The expansion process is mechanical and is conducted with subsequent minimally invasive procedures following the initial implantation surgery.
Intended Use
The Distal Femoral Growing Prosthesis System offers a treatment option for patients requiring distal femoral replacement who have not achieved full skeletal maturity (open epiphysis). The devices are single use implants.
1
Indications
The Distal Femoral Growing Prosthesis is indicated for pediatric who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:
- . Oncology indications
- Severe trauma .
- Noninflammatory degenerative joint disease including osteoarthritis .
- Correction of functional deformity ◆
- Rheumatoid arthritis ●
- Revision procedures where other treatments or devices have failed .
The devices are single use implants and intended only for implantation with bone cement.
Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.
Summary of Technologies
The technological characteristics (material, design, sizes, and operational principles) of the Distal Femoral Growing Prosthesis System are similar or identical to its predicate devices.
Non-Clinical Testing
Non-clinical laboratory testing was performed to determine substantial equivalence. Single-axis and multi-axis life cycle testing of the Distal Femoral Growing Prosthesis was conducted to verify that the expansion feature of the device will not cause the subject component to collapse/retract before, after and during physiological loading. All specimens tested ran out without evidence of collapse of the device. Fatigue testing was also conducted on the Distal Femoral Growing Prosthesis crossover bearing component. All test specimens withstood physiological loading as compared to the predicate device.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The Distal Femoral Growing Prosthesis System devices are substantially equivalent to the predicate devices identified in this premarket notification.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The text is in all capital letters and is black. The eagle is also black and is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2013
Howmedica Osteonics Corporation % Ms. Christie Pencinger Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Re: K122015
Trade/Device Name: Distal Femoral Growing Prosthesis System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: December 20, 2012 Received: December 21, 2012
Dear Ms. Pencinger:
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
3
Page 2 -- Ms. Christie Pencinger
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erin.DKeith
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
510(k) Number (if known): K122015
Device Name: Distal Femoral Growing Prosthesis System
Indications
The Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (open epiphysis), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions:
- . Oncology indications
- Severe trauma .
- . Noninflammatory degenerative joint disease including osteoarthritis
- . Correction of functional deformity
- . Rheumatoid arthritis
- . Revision procedures where other treatments or devices have failed
The devices are single use implants intended only for implantation with bone cement.
Compatible components of the GMRS, MRH, MRS, and KRH when used with the Distal Femoral Growing Prosthesis are intended for use in pediatric patients for the abovementioned indications.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3.02.22 09:58:36 Page 1 of 1 Anton E. Dmitriev, PhD Division of Orthopedic Devices L