REACH HIP COMPONENT by BIOMET, INC.

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 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").

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Reach Femoral Hip Component." It describes the device, its intended use, potential risks, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics. The FDA's letter explicitly states that the device is determined to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the information provided. The document simply doesn't contain that type of data.

Summary

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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.

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

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

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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.

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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 (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,

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

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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(Per 21 CFR 801.109)	OR	Over-The-Counter-Use(Optional Format 1-2-96)
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(Division Sign-Off) Division of General Restorative Devices

510(k) Number_

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.