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
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K993438 , K002379 , K003363 , K011110 , K042037 , K043537 , K061423 , K062995
• Predicate For: K083642

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.

AI/ML Overview

This 510(k) summary is for the Biomet® Metal-on-Metal Hip Systems-Expanded Contraindications. Based on the provided document, the device did not undergo clinical testing to prove its acceptance criteria because it was determined to be "substantially equivalent" to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable

Explanation: The document explicitly states: "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." The basis for clearance was "substantial equivalence" to legally marketed predicate devices, meaning that the technological characteristics (materials, design, sizing, and indications) are considered identical. The only change highlighted is "Contraindications have been expanded to include patients with chronic renal failure and patients who are pregnant or may become pregnant." This indicates a change in labeling rather than a change requiring new performance data.

2. Sample size used for the test set and the data provenance

Not applicable, as no new clinical or non-clinical testing was performed as a basis for substantial equivalence. The clearance was based on demonstrating equivalence to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no new clinical or non-clinical testing was performed.

4. Adjudication method for the test set

Not applicable, as no new clinical or non-clinical testing was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hip prosthesis, not an AI-assisted diagnostic tool or imaging system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hip prosthesis, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no new clinical or non-clinical testing was performed. The "ground truth" for the clearance was the existing performance and safety profile of the predicate devices.

8. The sample size for the training set

Not applicable, as no new development or testing using training sets (as in machine learning) was conducted. The device is a physical hip prosthesis.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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

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

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

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.

{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" 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.

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

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

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

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

Page 1 of 1

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.