Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)

Device Description

Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.

AI/ML Overview

This 510(k) premarket notification describes a medical device, the Biolox® delta Option Ceramic Heads, which is a component of a total hip joint replacement. The document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting de novo clinical study data to meet specific acceptance criteria for a novel device.

Therefore, many of the requested categories (2-9) regarding specific study details, sample sizes, expert involvement, and ground truthing are not applicable or provided in this 510(k) submission. The core of this submission is non-clinical testing and comparison to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
All parameters of the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" were met.	"All parameters of the 'Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems' were meet for the devices contained in this 510(k)." (This statement serves as the primary performance claim, indicating compliance with established non-clinical testing standards for ceramic hip systems).
Substantial Equivalence to Predicate Devices	The device is deemed "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices" (as per the FDA's letter) based on similar technology and meeting the guidance document for ceramic ball hip systems.

Explanation of the "Acceptance Criteria" for this type of submission: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are typically defined by regulatory guidance documents and the demonstration that the new device is as safe and effective as a legally marketed predicate device. For the Biolox® delta Option Ceramic Heads, fulfilling all parameters outlined in the "Guidance Document for the Preparation of Pre-Market Notifications for Ceramic Ball Hip Systems" serves as the primary acceptance criterion related to device performance and safety.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No clinical test set data from human subjects is presented or required for this type of 510(k). The evaluation relies on non-clinical testing and comparison to predicates.
Data Provenance: Not applicable. The "testing" mentioned is non-clinical, likely mechanical and material testing, rather than data from human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No expert ground truth establishment for a test set of human data is described as clinical testing was not provided.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study was not conducted or presented. The submission explicitly states "Clinical Testing: None provided."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This medical device is a physical implant (ceramic hip head), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. For this 510(k), the "ground truth" for the device's acceptability is established through conformity to regulatory guidance documents for ceramic hip systems (non-clinical testing) and demonstration of substantial equivalence to predicate devices with established safety and effectiveness records. There isn't a "ground truth" in the clinical sense (e.g., pathology, outcomes data) derived directly from a study for this submission.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K082996 (pg 1/2)

Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and a registered trademark symbol. Below the logo, the words "MANUFACTURING CORP" are printed in a simple, sans-serif font.

510(k) Summary

Date: December 8, 2008

JAN 1 5 2009

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: Biolox® delta Option Ceramic Heads

Common or Usual Name: Ceramic Modular Head

Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K051411, K061312, K073102

Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.

Indications For Use: Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:

Mailing Address

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

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510(k) Summary 36mm Biolox® delta Option Ceramic Heads Biomet Manufacturing Corp. Page 2

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis.

Summary of Technologies: The Biolox® delta Option Ceramic Heads are technologically similar to the predicate devices.

Non-Clinical Testing: All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were meet for the devices contained in this 510(k).

Clinical Testing: None provided

Biolox is a trademark of CeramTec AG

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet, Inc. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Dr. P.O. Box 587 Warsaw, Indiana 46581

JAN 15 2009

Re: K082996

Trade/Device Name: Biolox delta Option Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZO Dated: December 15, 2008 Received: December 17, 2008

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your because is reley per is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorolate) to regary actment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food. Drug, devices that have been require approval of a premarket approval application (PMA). and Costhere Act (Act) that to hot require appen a controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classifica (sec above) the exist on on regulations affecting your device can
may be subject to such additional controls. Existing major regulations and sec may be subject to such additional controller Entisting Canyon of Solo to 898. In addition, FDA may be found in the Code of I casial roogening your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualles of a substition with other requirements of the Act
that FDA has made a determination that your device with other requires . You must that FDA nas made a decisimilation administered by other Federal agencies. You must or any Federal statules and regulations daministered of not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: re comply with an the Act s requirements, merceing, which and 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 (200 10thi in the quality systems (QD) regalsms (Sections 531-542 of the Act); 21 CFR 1000-1050. product faulation control provisions (Seting your device as described in your Section 510(k) This letter whil anow you to begin marketing your antial equivalence of your device to a legally premarket notification: "The PDF interessification 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 If you desire specific advice for your association is (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 270-0120. This, procese now around of .97). For questions regarding postmarket surveillance, premarket nonneanon (210) It = Liv veillance and Biometric's (OSB's) Division of Postmarket prease contact CDAT 3 Office of Darrensting the reporting of device adverse events Surveillance at (240) 216 317 17103)), please contact the Division of Surveillance Systems (Medical Device Reporting (MDFT)), proacs veral information on your responsibilities under the at (240) 270-5101. Totallay of Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

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

510(k) Number (if known): _ 长沙829966991/1)

Device Name: Biolox® delta Option Ceramic Heads

Indications For Use: Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

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

Specific indications for compatible components that can be used with the above modular heads include:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

(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,
and Neurological Devices

510(k) Number-

Page 1 of 1

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.