BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

• K Number: K082446
• Device Name: BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
• Manufacturer: BIOMET, INC.
• Date Cleared: 2008-10-15 ( 51 days)
• Product Code: KWA
• Regulation Number: 888.3330

Intended Use

K993438, K011110, K042037, K043537, K061423, K062995: 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis. 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 using other techniques. 5. Revision of previously failed total hip arthroplasty. K002379, K003363: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Revision procedures where other treatment or devices have failed. 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Device Description

The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo head articulates with Co-Cr-Mo.

Predicate Devices

K993438, K002379, K003363, K003363, K011110, K042037, K043537, K061423, K062995

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hip replacement system consisting of mechanical components and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.

Therapeutic

Yes
The device is a total hip arthroplasty system, which is used to treat various joint diseases and deformities, indicating a therapeutic purpose.

Diagnostic

No

This device is a total hip arthroplasty system, indicated for the treatment of various degenerative joint diseases and fractures, as well as for revision procedures. It is a therapy device (implant) and not intended for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of physical components like acetabular cups, femoral heads, adapters, and inserts, which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended uses clearly describe the device as being used for the treatment of various hip joint conditions through surgical implantation (total hip arthroplasty and revisions). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
• Device Description: The device is described as consisting of physical components (acetabular cups, femoral heads, adapters, inserts) made of materials like Co-Cr-Mo. These are implantable medical devices, not reagents, instruments, or systems used to examine specimens.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The description focuses on the physical components and their function in replacing or repairing a joint.

Therefore, this device falls under the category of an implantable medical device used for surgical treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

K993438, K011110, K042037, K043537, K061423, K062995:

• 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis.
• 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 using other techniques.
• 5. Revision of previously failed total hip arthroplasty.

K002379, K003363:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Revision procedures where other treatment or devices have failed.
• 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Product codes (comma separated list FDA assigned to the subject device)

KWA

Device Description

The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo head articulates with Co-Cr-Mo.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: Non-clinical laboratory testing is not provided as a basis for substantial equivalence.
Clinical Testing: None provided as a basis for substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993438, K002379, K003363, K003363, K011110, K042037, K043537, K061423, K062995

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Summary

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K082446

OCT 1 5 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a registered trademark symbol. Below the logo is the text "MANUFACTURING CORP".

510(k) Summary

October 7, 2008 Preparation Date:

• Applicant/Sponsor: Biomet Manufacturing Corp.
• Contact Person: Becky Earl

Proprietary Name: Biomet® Metal on-Metal Hip Systems-Expanded Contraindications

• Common Name: Hip prosthesis, metal-on-metal articulation
  Classification Name: Class III (Preamendment), 21 CFR §888.3330, KWA

• KWA- Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis .

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Metal-on-Metal Acetabular System-K993438 (Biomet, Inc.) M2a™ 28mm RingLoc™ Liner-K002379 (Biomet, Inc.) M2a™ 32mm Taper System-K003363 (Biomet, Inc.) M2a™ Acetabular System-K011110 (Biomet, Inc.) M2a-Maqnum™ System-K042037 (Biomet, Inc.) TaperLoc® 12/14 Femoral Components and One-Piece Modular Heads-K043537 (Biomet, Inc.) M2a Magnum™ 12/14 Taper Inserts and One-Piece Modular Heads-K061423 (Biomet, Inc.) M2a-Magnum™ Tri-Spike™ Acetabular Component-K062995 (Biomet, Inc.)

Device Description:

The systems consist of acetabular cups, femoral heads, and adapters and inserts. The Co-Cr-Mo head articulates with Co-Cr-Mo.

Indications for Use/Intended Use:

K993438, K011110, K042037, K043537, K061423, K062995:

• 1. Non-inflammatory degenerative ioint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis.
• 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 using other techniques.
• 5. Revision of previously failed total hip arthroplasty.

Mailing Address: P.O Box 587 Wars w IN 46581 0587 Toll Free: 800 3-18 9500 Office: 574 257 6839 Main Fax: [phone] www.blomel.com

Shipping Address: 60 East Bell Drive Warsaw, IN 46582

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510(k) Summary Biomet® Metal-on Metal Hip Systems - Expanded Contraindications Biomet Manufacturing Corp. Page 2 of 2

K002379, K003363:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Revision procedures where other treatment or devices have failed.
• 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Contraindications have been expanded to include patients with chronic renal failure and patients who are pregnant or may become pregnant.

Summary of Technologies:

The technological characteristics (materials, design, sizing, and indications) of the Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications are identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing is not provided as a basis for substantial equivalence.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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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" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K082446

Trade/Device Name: Biomet® Metal-on-Metal Systems- Expanded Contraindications Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: August 20, 2008 Received: August 25, 2008

Dear Ms. Earl:

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 (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 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 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.

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Page 2 - Ms. Becky Earl

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

-082446 510(k) Number (if known):

Device Name: Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications

Indications for Use/Intended Use:

K993438, K011110, K042037, K043537, K061423, K062995:

• 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis.
• 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 using other techniques.
• 5. Revision of previously failed total hip arthroplasty.

K002379, K003363:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Revision procedures where other treatment or devices have failed.
• 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Prescription Use X	AND/OR	Over-The-Counter Use NO
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Nal R firm
Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K082446

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