TAPERLOC 12/14 TAPER FEMORAL COMPONENTS

K043537 · Biomet, Inc. · LPH · Jan 14, 2005 · Orthopedic

Device Facts

• Record ID: K043537
• Device Name: TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Taperloc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in cemented or non-cemented total hip replacement in cases of: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis - Correction of functional deformity - Correction of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. - Revision of previously failed total joint replacement. The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

Device Story

Taperloc® 12/14 Taper Femoral Components are straight, collarless, flat, tapered femoral stems; available in sizes 5.0mm to 25.0mm; includes lateralized version. Manufactured from titanium alloy (Ti-6Al-4V); proximal third features plasma spray porous coating. Used in total hip arthroplasty; implanted by orthopedic surgeons in clinical/OR settings. Device provides structural support for hip joint replacement; facilitates bone ingrowth via porous coating. Benefits include restoration of joint function and stability in patients with degenerative disease, fractures, or failed prior implants.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by engineering analysis and comparison of design/material characteristics to predicate devices.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F-136 or F-1472. Design: Straight, collarless, flat, tapered femoral stem. Surface: Proximal third plasma spray porous coating. Form factor: Proportional sizing (5.0mm to 25.0mm diameters), lateralized options available. Energy source: None (mechanical implant).

Indications for Use

Indicated for patients requiring total hip replacement (cemented or non-cemented) due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (non-union, neck, trochanteric), or revision of failed joint replacement. Freedom Constrained Modular Head indicated for patients at high risk of dislocation (prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, intra-operative instability).

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis (K030055)
• Taperloc® Femoral Stem and Universal Acetabular Component (K921301)
• CFE Total Hip Femoral Component – Porous Coated (K830313)
• SHP Hip System (K960984)
• M2a™ Acetabular System (K011110)
• Freedom™ Constrained Liner (K030047)

Submission Summary (Full Text)

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K041537 pge 142

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## 510(k) Summary

Applicant/Sponsor:Biomet Manufacturing Corp.

Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist

Proprietary Name: Taperloc® 12/14 Taper Femoral Components

Common Name: Total hip replacement device

## Classification Names:

- 1) Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3358)
- 2) Prosthesis, hip, semi-constrained, metal/polymer, porous coated, cemented (21 CFR 888.3350)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K030055 - Expanded Indications for Non-cemented Porous Coated Total Hip Prosthesis

K921301 – Taperloc® Femoral Stem and Universal Acetabular Component

K830313 – CFE Total Hip Femoral Component – Porous Coated

K960984 - SHP Hip System

K011110 - M2a™ Acetabular System

K030047 - Freedom™ Constrained Liner

Device Description: The Taperloc® 12/14 Taper Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. A lateralized version of the device is available. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and the proximal third of each femoral stem is covered with Biomet's full plasma spray porous coating.

Intended Use: The Taperloc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in non-cemented and/or cemented total hip replacement in cases of:

- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)

MAILING ADDRESS PO. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E Roll Drive Warsaw, 1N 46582

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OFFICE 574 267 6659 100

FAX [phone]

E-MAIL [e-mail]

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510(k) Summary Taperloc® 12/14 Taper Femoral Components Biomet Manufacturing Corp.

- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed total joint replacement. 5)

The Biomet Freedom® Constrained Modular Head is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device

Non-Clinical Testing: Engineering analysis has demonstrated equivalence between the Taperloc® 12/14 Taper Femoral Components and the predicates.

Clinical Testing: None provided

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 a stylized graphic of an abstract human figure, represented by three curved lines, which is a common symbol associated with the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

Ms. Patricia Sandborn Beres Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46582

Re: K043537

Trade/Device Name: Taperloc® 12/14 Taper Femoral components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 21, 2004

Received: December 22, 2004

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 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. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yours ough timing of substantial equivalence of your device to a legally prematics notication. "The 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 If you dosire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whoordinant of responsibilities under the Act may be obtained from the Other general 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 yours,

R. Mark N. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko44537

## Indications for Use

510(k) Number (if known): K043537

Device Name: Taperloo® 12/14 Taper Femoral Components

Indications For Use:

The Taperioc® 12/14 Taper Femoral Components and M²a-38™ Modular Heads are indicated for use in cemented or non-cemented total hip replacement in cases of:

- ated for doe in oomentoo joint disease including osteoarthritis and avascular 1) necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Conection of non-union, femoral neck fracture, and trochanteric fractures of the 4) rroximal femur with head involvement, unmanageable by other techniques.
- Revision of previously failed joint replacement. 5)

The Biomet Freedom® Constrained Modular Head is indicated for use as a component The blomet I recome ochetany and revision patients at high risk of dislocation due to of a lotal hip prostinolo in primary loss, joint or soft tissue laxity, neuromuscular a mistory of phor disionity, and for whom all other options to constrained acetabular components have been considered.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

ORH. Office of Device Evaluation (ODE)

Mark H. Milkern
(Division Sign-Off)

I. Restorative. and Neurological Devices

**510(k) Number** K043537

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