(382 days)
No
The summary describes a mechanical orthopedic implant and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a prosthetic replacement used in surgical interventions for conditions like severe trauma and oncology, aiming to restore function and mitigate symptoms.
No
Explanation: The device is a modular replacement system for the distal femur/proximal tibia, used in surgical procedures for limb salvage. It is a prosthetic replacement and not described as providing diagnostic information.
No
The device description clearly states it is a "Modular Replacement System - Distal Femoral/Proximal Tibial Segments," which are physical implants used in surgical procedures. It also mentions fixation by "bone cement," further indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a prosthetic implant used for surgical replacement of the distal femur and proximal tibia. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical replacement in limb salvage procedures, which is a surgical intervention, not an in vitro test.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
Product codes
KRO
Device Description
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur/proximal tibia is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur/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)
A comparison to other legally marketed products was made, and testing of the modular tapers was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 3 1898
- 510(k) Summary
Device: Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur/proximal tibia is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
A comparison to other legally marketed products was made, and testing of the modular tapers was presented.
For information contact:
Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 Fax: (201) 507-6870
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Ms. Margaret F. Crowe ·Group Requlatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K972401 Re: Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments Requlatory Class: II Product Code: KRO Dated: May 13, 1998 Received: May 14, 1998
Dear Ms. Crowe:
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 The general controls provisions of the Act 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 requlation (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 Reqister. 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 - Ms. Margaret F. Crowe
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) 594-4659. 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 807.97). Other gener 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,
Colin M. Witter, Ph.D., M.
Celi M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments
Indications for Use:
The Howmedica® Modular Replacement System - Distal Femoral/Proximal Tibial Segments are presently cleared for use with bone cement in Oncology patients where radical resection and replacement of the distal femur is required (reference premarket notification K952970). Howmedica seeks clearance to expand this indication to include use with bone cement in limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or Oncology indications. All of these surgical interventions have in common the need for radical resection of the distal femur/proximal tibia, and the need for a prosthetic replacement. This device achieves fixation by the use of bone cement.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | Over-The-Counter Use ________ |
(Optional Format 1-2-96)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972401 |
| 510(k) Number |