B2C HIP SYSTEM

K992490 · Lepine Groupe Spa. · JDI · Aug 19, 1999 · Orthopedic

Device Facts

• Record ID: K992490
• Device Name: B2C HIP SYSTEM
• Applicant: Lepine Groupe Spa.
• Product Code: JDI · Orthopedic
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity. The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup.

Device Story

B2C Hip Stem System is a femoral component for total hip arthroplasty; designed for press-fit or cemented implantation into the femoral cavity. Used in conjunction with an acetabular cup to restore joint function. Operated by orthopedic surgeons in a clinical/surgical setting. Device provides structural replacement of the femoral head and neck; aids in restoring mobility and reducing pain for patients with degenerative joint disease, fractures, or failed prior surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device design and intended use.

Technological Characteristics

Femoral hip stem component; designed for press-fit or cemented fixation. Material composition and specific ASTM standards not provided in the document.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or arthritis secondary to diseases/anomalies. Also indicated for salvage of failed procedures (osteosynthesis, joint reconstruction, arthrodesis, hemi/total hip arthroplasty), bipolar or Austin Moore head revision, fracture or avascular necrosis of the femoral head in the elderly, primary arthroplasty of the acetabulum in dysplastic hips, and replacement of acetabular and stem components.

Regulatory Classification

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1999

Mr. Douglas W. Stuart Lepine Group Spa. C/O Surgical Implants Incorporated 962 South Tamiami Trail, Suite 203 Sarasota, Florida 34326

Re: K992490 Trade Name: Lepine, B2C Hip System Regulatory Class: II Product Code: JDI Dated: July 21, 1999 Received: July 26, 1999

Dear Mr. Stuart:

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 control provisions of the Act. The general control 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 (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 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 action. In addition, FDA may publish further announcements 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.

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Page 2 - Mr. Douglas W. Stuart

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,

Russell Sage

Ser 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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## page 6

## EXHIBIT 9

K 992490 510(K) Number not known Device Name: B2C Hip Stem System

## Statement of Intended Use

## Indications For Use:

The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity.

The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.

Signed:

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Russell Ligone Sor Jr

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992490

**Prescription Use** X
(Per 21 CFR 801.109)

.

OR

Over The Counter Use _

(Optional Format 1-2-96)