X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS

• K Number: K030501
• Device Name: X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2003-03-20 ( 29 days)
• Product Code: LPH
• Regulation Number: 888.3358

Intended Use

Non-cemented total joint replacement in cases of: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5) Revision of previously failed total hip arthroplasty

Device Description

The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.

Predicate Devices

K984296

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant (femoral component for hip replacement) and mentions only engineering analysis and finite element analysis for performance testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML device descriptions.

Therapeutic

Yes

This device is a total joint replacement component, specifically for the hip, indicated for conditions like osteoarthritis, rheumatoid arthritis, and fractures. Its purpose is to treat these medical conditions by replacing damaged anatomical structures, which aligns with the definition of a therapeutic device.

Diagnostic

No
Explanation: The device description clearly states it is a "total joint replacement" and lists indications for conditions requiring such a replacement, not for diagnosing them.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a femoral component manufactured from titanium alloy, indicating it is a physical implant, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
• Device Description: The provided description clearly states that this device is a non-cemented total joint replacement for the hip. It is an implantable device used to replace a damaged joint.
• Intended Use: The intended uses listed are all related to the surgical replacement of a hip joint due to various conditions. This is a surgical procedure, not a diagnostic test performed on a specimen.

Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Non-cemented total joint replacement in cases of:

• 1. Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Product codes

LPH

Device Description

The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip (proximal femur)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.
Clinical Testing: None provided

Key Metrics

Not Found

Predicate Device(s)

K984296

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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K03050/ page 1 of 2

BIOMET

MAR 2 0 2003

Summary of Safety and Effectiveness

Applicant/Sponsor: Biomet Orthopedics, Inc.

Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: [phone]

Proprietary Name: X-Series Integral® Hip Femoral Components

Common Name: Hip replacement prosthesis

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3558)

Legally Marketed Device to which Substantial Equivalence is Claimed: Integral® Hip Femoral Component (K984296)

Device Description: The X-Series Integral® femoral components are identical to the predicate Integral® femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F-620. Additional stem diameters and lengths have been added to the product line. The insertion hole has been moved medially by 6mm.

Indications for Use: Non-cemented total joint replacement in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS SHEFRING ADDRE: Bell Drive: Warsaw, IN 46582

.

()FFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

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page 2 of 2

Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.

Clinical Testing: None provided

Integral is a trademark of Biomet, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle 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

MAR 2 0 2003

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581

Re: K030501

Trade/Device Name: X-Series Integral® Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: February 14, 2003 Received: February 19, 2003

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Patricia Sandborn Beres

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

O Mark McMullen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: X-Series Integral® Femoral Components

Indications For Use:

Non-cemented total joint replacement in cases of:

• 1. Noninflamatory degenerative joint disease including osteoarthritis and avascular necrosis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision of previously failed total hip arthroplasty

Mach N. Melhern
Division Supt. of M

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030501

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use h 2 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)