QUATRO M FEMORAL COMPONENT

K033313 · Whiteside Biomechanics, Inc. · LWJ · Jul 28, 2004 · Orthopedic

Device Facts

• Record ID: K033313
• Device Name: QUATRO M FEMORAL COMPONENT
• Applicant: Whiteside Biomechanics, Inc.
• Product Code: LWJ · Orthopedic
• Decision Date: Jul 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use. It is intended to be used for: 1 . Noninflammatory degenerative joint disease including osteoarthritis 2. Rheumatoid arthritis 3. Avascular necrosis 4. Correction of functional deformity 5. Revision procedures where other treatments or devices have failed 6. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

Device Story

Quatro-M Femoral Component is a hip prosthesis component; designed for press-fit, uncemented implantation. Device consists of a solid, rectangular cross-sectioned wrought titanium 6AL-4V stem with a tapered proximal end; features a modular spherical head interface. Proximal stem surfaces are porous-coated with commercially pure titanium plasma spray for bone ingrowth; distal portion is smooth with grit-blasted surfaces. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Device articulates with a surgeon-selected acetabular implant. Provides structural support and joint articulation to restore hip function; addresses degenerative disease, fractures, and revision needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Wrought titanium 6AL-4V (ASTM F1472). Surface: Commercially pure titanium plasma spray porous coating on proximal stem; grit-blasted distal surface. Design: Solid, rectangular cross-sectioned stem with tapered proximal end for modular head. Sterilization: 100% ethylene oxide and nitrogen per AAMI guidelines.

Indications for Use

Indicated for patients requiring hip arthroplasty due to noninflammatory degenerative joint disease (osteoarthritis), rheumatoid arthritis, avascular necrosis, functional deformity, revision of failed prior treatments, or non-unions/fractures of the proximal femur.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Quatroloc Plasma Spray Femoral Component (K964616)

Submission Summary (Full Text)

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| Section 4: | K033313<br>page 1 of 1<br>510(k) Summary |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| JUL 2 8 2004 | |
| Submitter Name/Address: | Whiteside Biomechanics, Inc.<br>12634 Olive Blvd.<br>St. Louis, MO 63141<br>P: 314-996-8540<br>F: 314-996-8543 |
| Establishment Registration #: | 1932213 |
| Correspondent: | Amy Cranmer |
| Device Name: | Quatro-M Femoral Component |
| Proprietary Name: | Whiteside Biomechanics, Inc. Quatro-M Femor<br>Component |
| Common Name: | Quatro-M |
| Classification Name: | Prosthesis, hip, semi-constrained, metal/polymer<br>uncemented (LWJ); Prosthesis, hip, semi-<br>constrained, metal/polymer, porous uncemented<br>(LPH); and Prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer cemented or non-porous<br>uncemented (LZO) |
| Classification Panel: | Class II |
| Substantial Equivalence To: | Quatroloc Plasma Spray Femoral Component<br>(K964616) |

## Device Description:

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6AL-4V (ASTM 1472) stem with tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and medial – laterally with a grit blasted distal surfaces. The proximal stem will be porous coated with commercially pure titanium plasma spray on all proximal surfaces excluding the articular interface trunion.

The femoral component is made of wrought titanium 6A1-4V (ASTM F1472). The proximal portion of the stem will be porous coated on all surfaces, excluding the ball trunion. The distal portion of the stem will be grit blasted. Sterilization will be 100% ethylene oxide and nitrogen in accordance with AAMI guidelines for sterilization.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 2004

Ms. Amy Cranmer Official Correspondent Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141

Re: K033313

Trade/Device Name: Quatro-M Plasma Spray Femoral Component Regulation Number: 21 CFR 888.3350; 21 CFR 888.3358; 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis

Regulatory Class: II Product Code: LWJ, LPH, LZO Dated: July 8, 2004 Received: July 8, 2004

Dear Ms. Cranmer:

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

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## Page 2 – Ms. Amy Cranmer

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.

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/dsma/dsmamain.html

Sincerely yours,

Mark A Millman

Celia 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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## Indications for Use

510(k) Number (if known): K033313

Device Name: Quatro-M Plasma Spray Femoral Component

Indications for Use:

The Quatro-M Plasma Spray Femoral Component is for press-fit, uncemented use. It is intended to be used for:

- 1 . Noninflammatory degenerative joint disease including osteoarthritis
- ನ Rheumatoid arthritis
- .
Pri Avascular necrosis
- Correction of functional deformity 4.
- ર . Revision procedures where other treatments or devices have failed
- Treatment of non-unions, femoral neck and trochanteric fractures of the proximal Q. femur with head involvement that are unmanageable using other techniques

Prescription Use: Yes (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number***_****_* K033313