BIOLOX DELTA OPTION CERAMIC HEADS

K082996 · Biomet, Inc. · LZO · Jan 15, 2009 · Orthopedic

Device Facts

• Record ID: K082996
• Device Name: BIOLOX DELTA OPTION CERAMIC HEADS
• Applicant: Biomet, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 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. 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.

Device Story

Biolox® delta Option Ceramic Heads serve as modular bearing surfaces for total hip joint replacement. Device consists of highly polished spherical ceramic head articulating with polyethylene acetabular liner. Modular head attaches to metallic femoral stem via taper adapter (Biomet Type I or 12/14 taper). Used by orthopedic surgeons in clinical/OR settings during primary or revision hip arthroplasty. Device provides durable, low-friction articulation to restore joint function and mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing in accordance with the FDA Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems.

Technological Characteristics

Modular ceramic hip head; material: Biolox® delta ceramic; articulation: spherical head against polyethylene liner; connection: taper adapter (Biomet Type I or 12/14); sterilization: not specified.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures/non-union, or revision procedures. Compatible with specific salvage/oncology and interlocking hip systems for cases involving ligament deficiency, tumor resection, trauma, or severe proximal bone loss.

Regulatory Classification

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.

Predicate Devices

• Biolox® delta Ceramic Heads (K042091)
• Biolox® delta Ceramic Heads (K051411)
• Biolox® delta Ceramic Heads (K061312)
• Biolox® delta Ceramic Heads (K073102)

Reference Devices

• Salvage/Oncology Hip and Total Femur System components (K974558)
• Salvage/Oncology Hip and Total Femur System components (K002757)
• Salvage/Oncology Hip and Total Femur System components (K021380)
• Salvage/Oncology Hip and Total Femur System components (K033871)
• Interlocking hip stems (K990830)
• Interlocking hip stems (K042774)

Submission Summary (Full Text)

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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
- 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 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.

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.

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. 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 [phone]. Totallay of 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 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
- 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 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)

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-

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