LATERAL FLARE INTERNAL COLLAR (LFIC)

K971900 · Pro-Lfic, LLC · LWJ · Dec 18, 1997 · Orthopedic

Device Facts

• Record ID: K971900
• Device Name: LATERAL FLARE INTERNAL COLLAR (LFIC)
• Applicant: Pro-Lfic, LLC
• Product Code: LWJ · Orthopedic
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures. The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., , P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.

Device Story

Lateral Flare Internal Collar (LFIC) is a femoral hip prosthesis component. Device is designed for press-fit insertion into the intramedullary canal of the human femur during total hip replacement surgery. It serves as a structural replacement for the femoral head/neck in patients with degenerative or pathological hip conditions. The device is manufactured from Tivanium (Ti-6Al-4V alloy) and features an anatomic shape. It is intended for use by orthopedic surgeons in a clinical/hospital setting. The device provides mechanical stability and restores joint function, aiming to alleviate pain and disability associated with hip joint failure.

Technological Characteristics

Material: Tivanium (Ti-6Al-4V alloy). Design: Anatomic shape, press-fit femoral stem. Intended for intramedullary canal placement.

Indications for Use

Indicated for patients with severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, failed endoprosthesis/total hip components, or acute femoral neck fractures.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Zimmer LFIC Hip Prosthesis (K952776)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1997

Irving L. Wiesen, Esq. Representing Pro-Lfic LLC 500 West Putnam Avenue, Third Floor Greenwich, Connecticut 06830

Re: K971900 Lateral Flare Internal Collar (LFIC), (proportional sizes) Regulatory Class: II Product Code: LWJ September 24, 1997 Dated: Received: September 29, 1997

Dear Mr. Wiesen:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 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 requlations.

{1}------------------------------------------------

Page 2 - Irving L. Wiesen, Esq.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1997

Irving L. Wiesen, Esq. Representing Pro-Lfic LLC 500 West Putnam Avenue, Third Floor Greenwich, Connecticut 06830

Re: K971900 Lateral Flare Internal Collar (LFIC), (proportional sizes) Regulatory Class: II Product Code: LWJ September 24, 1997 Dated: Received: September 29, 1997

Dear Mr. Wiesen:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 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 requlations.

{3}------------------------------------------------

Page 2 - Irving L. Wiesen, Esq.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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510(k) Number (if known):

Device Name: Lateral Flare Internal Collar (LFIC)

Indications For Use:

The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures.

The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc., , P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for pressfit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

tcoles

Division of General Restorative Devices
510(k) Number

.

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)