(212 days)
This femoral component of the hip is indicated for use in patients with: 1 - Osteoarthritis - 2 Rheumatoid Arthritis - 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.
The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use.
The provided text is a 510(k) summary for a medical device (SMC Femoral Component) and does not describe any acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device. This document is a regulatory submission for a traditional medical implant, a hip femoral component, seeking substantial equivalence to predicate devices. It focuses on the physical design, materials, and intended uses of the implant.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because these concepts are not applicable to the content of this 510(k) submission.
The document implicitly states the acceptance criteria were met by the FDA's determination of substantial equivalence to predicate devices (DePuy AML Femoral Component K852198, BioPro Horizon Femoral Component K962769, Whiteside Biomechanics K961625, and StelKast Proform Cemented Femoral Component K951083). This determination is based on the device's design, materials, and indications for use being similar to those legally marketed devices. However, this is a regulatory acceptance, not a performance study as would be conducted for an AI/ML device.
{0}------------------------------------------------
12971681 DEC =4 p
510K SUMMARY OF SAFETY AND EFFECTIVENESS
The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). If further information is required please contact Dr. Louis Serafin, Signal Medical Corporation, 3315 Berry Drive, Lakeport, MI 48059, phone - 810-385-8302. This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use. This femoral component of the hip is indicated for use in patients with:
1 - Osteoarthritis
- 2 Rheumatoid Arthritis
- 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.
-3-
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Louis A. Serafin, Jr., M.D. ·President Signal Medical Corporation 3315 Berry Drive Lakeport, Michigan 48059
K971681 Re : SMC Femoral Component Trade Name: Regulatory Class: II Product Codes: JDI and LPH Dated: September 5, 1997 Received: September 12, 1997
Dear Dr. Serafin:
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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
{2}------------------------------------------------
Page 2 - Louis A. Serafin, Jr., M.D.
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 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,
Celia M. Witten, Ph.D.
a 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}------------------------------------------------
12971681 DEC =4 p
510K SUMMARY OF SAFETY AND EFFECTIVENESS
The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). If further information is required please contact Dr. Louis Serafin, Signal Medical Corporation, 3315 Berry Drive, Lakeport, MI 48059, phone - 810-385-8302. This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use. This femoral component of the hip is indicated for use in patients with:
1 - Osteoarthritis
- 2 Rheumatoid Arthritis
- 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.
-3-
{4}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Louis A. Serafin, Jr., M.D. ·President Signal Medical Corporation 3315 Berry Drive Lakeport, Michigan 48059
K971681 Re : SMC Femoral Component Trade Name: Regulatory Class: II Product Codes: JDI and LPH Dated: September 5, 1997 Received: September 12, 1997
Dear Dr. Serafin:
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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
{5}------------------------------------------------
Page 2 - Louis A. Serafin, Jr., M.D.
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 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,
Celia M. Witten, Ph.D.
a M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k)Number(ifknown):________________________________________________________________________________________________________________________________________________________
SMC FEMORAL COMPONENT Device Name: Indications For Use:
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Where the use of a more conservative procedure has failed or is unacceptable
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General Restorative Devices |
| 510(k) Number | K971681 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The- |
|---|---|---|---|
| Counter Use | |||
| (Per 21 CFR 801.109) |
ﺟﺔ ﻳﺘﺴﻌﺪ ﻳﺎ ﻳ
(Optional Format
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.