36MM BIOLOX DELTA CERAMIC HEADS

K061312 · Biomet, Inc. · LZO · Jun 6, 2006 · Orthopedic

Device Facts

• Record ID: K061312
• Device Name: 36MM BIOLOX DELTA CERAMIC HEADS
• Applicant: Biomet, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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

Modular ceramic hip prosthesis component; 36mm diameter Biolox® delta ceramic head. Functions as bearing surface in total hip arthroplasty; articulates with polyethylene acetabular liner. Attaches to metallic femoral stem via Biomet Type I taper. Used in clinical/surgical settings by orthopedic surgeons. Provides stable, wear-resistant articulation for hip joint replacement; facilitates restoration of joint function in patients with degenerative disease, fractures, or revision needs.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing in accordance with FDA guidance document for ceramic ball hip systems.

Technological Characteristics

Material: Biolox® delta ceramic. Form factor: 36mm diameter modular head with -3, 0, +3, +6 neck lengths. Interface: Biomet Type I taper. Application: Bearing surface for total hip replacement. 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, femoral neck, trochanteric), or revision of failed procedures. Compatible with Salvage/Oncology Hip, Total Femur System, and interlocking hip stems 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)

Reference Devices

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

Submission Summary (Full Text)

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K06/3/2

BIOMET

JUN - 6 2006

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: 36mm Biolox® delta Ceramic Heads

Common or Usual Name: Ceramic Modular Head

Classification Name: Hip joint/ceramic/polymer semiconstrained cemented or non-cemented prosthesis

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

Device Description: Biolox® delta Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. This submission covers 36mm diameter heads with neck lengths of -3, 0, +3 and +6.

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.

MAILING ADDRESS P.O. Box 587 50 - 130 130x 587
Warsaw, IN 46581-0587

OFFICE -574.267.6639

FAX
74.267.8137

56 E. Bell Drive Warsaw, IN 46582

SHIPPING ADDRESS

biome

E-MAIL | E-MAIL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

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 36mm Biolox® delta 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IUN - 6 2006

Biomet Manufacturing Corp. c/o Ms. Patricia Sandborn Beres, Senior Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K061312

Trade/Device Name: 36mm Biolox® delta Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II

Product Code: LZO Dated: May 9, 2006 Received: May 10, 2006

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

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## Page 2 - Ms. Patricia Sandborn Beres

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. 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 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/industry/support/index.html.

Sincerely vours.

Herbert Lehner us

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):

Device Name:_36mm Biolox® delta 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, turnor 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)

Hulut Lemen

Division of General, Restorative, and Neurological Devices

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510(k) Number_K061312