REACH HIP COMPONENT

K982367 · Biomet, Inc. · LPH · Aug 24, 1998 · Orthopedic

Device Facts

• Record ID: K982367
• Device Name: REACH HIP COMPONENT
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reach Femoral Component is indicated for use in: non-inflammatory degenerative joint disease a. oseoarthritis b. avascular necrosis c. d. rheumatoid arthritis revisions procedures where other devices or treatments have failed e. f. correction of functional deformities treatment of non-unions, femoral neck and trochanteric fractures of the g. proximal femur with head involvement. The Reach Femoral Stems are intended for press-fit application and for single use implants.

Device Story

Reach Femoral Hip Component; forged titanium femoral stem; designed for press-fit application in total hip arthroplasty. Proximal geometry features bi-planer taper for stress shielding reduction and rotational stability; duckbill porous-coated collar for load transfer and calcar contact. Distal stem is cylindrical with anterior bow to match femoral anatomy; distal tip polished to prevent pedestal effect. Device intended for single use; implanted by orthopedic surgeons in clinical/OR settings. Provides biological fixation via circumferential porous coating for bony ingrowth; compatible with Biomet acetabular components. Benefits include improved rotational stability, anatomical fit, and potential for long-term fixation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and functional characteristics compared to predicate devices.

Technological Characteristics

Forged titanium femoral stem; circumferential closed-pore porous coating; bi-planer proximal taper; cylindrical distal stem with anterior bow; polished distal tip. Designed for press-fit, uncemented application. No software or electronic components.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease, osteoarthritis, avascular necrosis, rheumatoid arthritis, those requiring revision of failed hip components, or treatment of non-unions, femoral neck, and trochanteric fractures of the proximal femur with head involvement.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• The Solution System Depuy (K933942, K941942, K953703)
• Integral Total Hip system, Biomet, Inc. (K921255)
• Foundation Porous Hip Stem, Encore Orthopedics (K973302)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 2 4 1998

K982367

## SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR: | Biomet, Inc. |
|----------|-------------------------|
| | Airport Industrial Park |
| | Warsaw, Indiana 46580 |

Reach Femoral Hip Component DEVICE:

CLASSIFICATION NAME: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis,

INTENDED USE: The Reach Femoral Component is indicated for use in:

- non-inflammatory degenerative joint disease a.
- oseoarthritis b.
- avascular necrosis c.
- d. rheumatoid arthritis
- revisions procedures where other devices or treatments have failed e.
- f. correction of functional deformities
- treatment of non-unions, femoral neck and trochanteric fractures of the g. proximal femur with head involvement.

The Reach Femoral Stems are intended for press-fit application and for single use implants.

DEVICE DESCRIPTION: The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with any Biomet's acetabular component.

The Reach stem geometry is designed for proximal, as well, distal stability and gradual offloading into the bone along the canal. The proximal 100-mm of each stem incorporates a bi-planer taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability.

The stem has a duckbill porous coated collar, which is incorporated to provide component stability and stress transfer. The underside of the collar is porous coated to help ensure collar-clacar contact and stress distribution. This helps to provide rotational stability and load transfer.

Distally, the stem is cylindrical with an anterior bow for left and right specific applications. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. The cylindrical design will also enhance implant stability

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

by providing a potential area of biological fixation in situations of proximal bone deficiencies.

The Reach femoral stems will be fully coated to provide maximum proximal and distal fixation through potential bony ingrowth. This circumferetial closed-pore porous coating potentially seals the femur from debris migration. Porous coating in the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long-term success. The distal tip of the stem is a polished finish, to prevent distal off loading and fixation of the tip (otherwise known as the "pedestal effect").

POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement device. These include, but not limited to:

| Fracture of the component | Bone fracture |
|-----------------------------|-----------------------------|
| Cardiovascular disorders | Hematoma |
| Implant loosening/migration | Blood vessel damage |
| Soft tissue imbalance | Nerve damage |
| Deformity of the joint | Excessive wear |
| Tissue growth failure | Infection |
| Delayed wound healing | Dislocation |
| Metal sensitivity | Breakdown of porous surface |

SUBSTANTIAL EQUIVALENCE: The Reach Femoral Hip Component is substantially equivalent to most femoral devices on the market in overall design and intended function. Predicate devices include:

The Solution System® Depuy, Warsaw, IN 510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem. Encore Orthopedics. Austin TX 510(K) 973302

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Ms. Julie K. Ryan Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

Re : K982367 Reach Femoral Hip Component Regulatory Class: II Product Codes: LPH and LZO Dated: July 6, 1998 Received: July 7, 1998

Dear Ms. Ryan:

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, Druq, and Cosmetic Act (Act). 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.

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. ದ substantially equivalent determination assumes compliance with ----the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlations.

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

## Page 2 - Ms. Julie K. Ryan

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 D. Lyon

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

{4}------------------------------------------------

510(k) NUMBER (IF KNOWN): K982367

Reach femoral Component DEVICE NAME:

INDICATIONS FOR USE:

The indications for use of the Reach Femoral Component are:

.

. .

a.) non-inflammatory degenerative disease

- osteoarthritis b.)
- C.) avascular necrosis
- rheumatoid arthritis d.)
- e.) revisions of hip replacement components
- treatment of non-union, femoral neck and trochanteric £.) fractures of the proximal femur with head involvement.

The Reach stem is intended for press-fit application and for single use implantation.

(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 | 982367 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|

(Division Sign-Off) Division of General Restorative Devices

510(k) Number_