PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS

K073637 · Biomet Manufacturing Corp · KWA · Mar 20, 2008 · Orthopedic

Device Facts

• Record ID: K073637
• Device Name: PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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 of previous failed total hip arthroplasty. The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Device Story

Parallel-Sided Extensively Coated Femoral Stem is a hip joint replacement prosthesis; replaces natural femoral hip component damaged by disease or accident. Device features cylindrical stem design with lateralized offset for patient fit; manufactured from wrought titanium alloy (Ti-6Al-4V) with porous coating for uncemented fixation. Used in orthopedic surgery; implanted by surgeons. Provides structural replacement for proximal femur; restores joint function; benefits patients by addressing degenerative disease, fractures, or failed prior arthroplasty.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence. Bench testing only.

Technological Characteristics

Material: Wrought titanium alloy (Ti-6Al-4V) per ASTM F136. Design: Parallel-sided cylindrical stem with porous coating for uncemented application; includes lateralized offset. Form factor: Femoral hip prosthesis. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) unmanageable by other techniques, and for revision of failed total hip arthroplasty. For uncemented use only.

Regulatory Classification

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).

Predicate Devices

• Reach® Revision System (K982367)
• AML® Hip Stem (K012364)
• XR-Series Bi-Metric® Femoral Stems (K052089)

Submission Summary (Full Text)

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K073637 page '92

MAR 2 0 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics, Inc. The logo is in black and white and features the word "BIOMET" in a stylized font with a superscripted "3". Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products, website, and marketing materials.

## 510(k) Summary

# Parallel-Sided Extensively Coated Femoral Stem

Preparation Date: December 21, 2007

Biomet Manufacturing Corp. Applicant/Sponsor:

Elizabeth Wray Contact Person:

Parallel-Sided Extensively Coated Femoral Stem Proprietary Name:

- Hip ioint femoral replacement device Common Name:
Classification Name: - Class II, 21 CFR §888.3358, §888.3350, and §888.3353.

The mating components (modular heads and acetabular shells/liners) for use with the Parallel-Sided Extensively Coated Femoral Stem have the following classifications:

- Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (888.3310) �
- Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350)
- Prosthesis, Hip, Semi-constrained, Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented (888.3353)
- Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous, Uncemented (888.3358) .
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented (888.3390)

#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Reach® Revision System- K982367, 08/24/98 (Biomet Inc.) AML® Hip Stem- K012364, 10/19/01 (DePuy Inc.) XR-Series Bi-Metric® Femoral Stems- K052089, 02/17/06 (Biomet Inc.)

#### Device Description:

The Parallel-Sided Extensively Coated Femoral Stem is designed to replace the patural femoral hip component due to disease or accident. The femoral hip prosthesis is made from wrought titanium alloy (Ti-6AI-4V) (ASTM F136) and has a porous coat, designed to be used in uncemented applications. The stem diameters and lengths are within the range of the previously cleared predicates. In addition to the cylindrical stem design, the Parallel-Sided Extensively Coated Femoral Stem offers a lateralized offset for optimal patient fit.

P.O. Box 587
Warsaw IN 46581-0557
Toll Free: 800 348 9500
Office 574 767 6539
Main Fax [phone]
www.biomet.com

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## Indications for Use/Intended Use:

- 1. Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2. Rheumatoid arthritis
- 3. Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur 4. with head involvement, unmanageable by other techniques.
- 5. Revision of previous failed total hip arthroplasty.

The Paraliel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

### Summary of Technologies:

The technological characteristics (materials, design, sizing, and indications) of the Parallel-Sided Extensively Coated Femoral Stem are similar or identical to the predicate devices or to other previously cleared devices.

## Non-Clinical Testing:

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc., except for AML®, which is a trademark of DePay, 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

MAR 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. c/o Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K073637 Trade/Device Name: Parallel-Sided Extensively Coated Femoral Stems Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH, JDI, KWY, KWZ Dated: December 21, 2007 Received: December 26, 2007

Dear Ms. Wray:

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. Elizabeth Wray

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 yours.

Mark M. Mulhausen

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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Page 1 of

# Indications for Use

510(k) Number (if known): __ Koフふん3 7

Device Name:

Indications for Use:

- 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 of previous failed total hip arthroplasty.

The Parallel-Sided Extensively Coated Femoral Stems are for uncemented applications only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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)

Souther
(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

**510(k) Number** K073637

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