PLUS ORTHOPEDICS CEMENTED HIP STEM

K031165 · Plus Orthopedics · JDI · Jun 6, 2003 · Orthopedic

Device Facts

• Record ID: K031165
• Device Name: PLUS ORTHOPEDICS CEMENTED HIP STEM
• Applicant: Plus Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Story

Cemented hip stem prosthesis; fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo). Features trapezoidal proximal body cross-section; cobra flange for compressive stress application; standard 12/14 Morse taper for modular heads; 129° neck/shaft angle; calcar collar. Distal stem includes four flutes for torsional stability and accepts PMMA distal centralizer. Proximal body includes 3mm PMMA spacers to ensure uniform cement mantle. Implanted by surgeons in clinical settings to replace diseased/traumatized femoral heads or failed arthroplasties; relieves pain and restores hip motion.

Clinical Evidence

Bench testing only. Engineering analysis performed to verify cyclic load-bearing capacity compared to predicate devices.

Technological Characteristics

Material: Forged CoCrMo alloy (ASTM F799). Design: Trapezoidal proximal body, cobra flange, 12/14 Morse taper, 129° neck/shaft angle, calcar collar. Distal features: Four flutes, PMMA distal centralizer, 3mm PMMA spacers. Mechanical fixation via bone cement.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to disease or trauma of the femoral head, or for revision of previously failed hip arthroplasties.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Consensus Stem (K922561)
• Foundation Hip (K991227)
• Synergy stem (K990369)
• Summit stem (K013352)

Submission Summary (Full Text)

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#### JUN - 6 2003 510(k) Summary

Date April 10, 2003

# Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

# Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock. TX 78681 212-388-0199

# Common name

Cemented Hip Stem

# Classification name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (per 21 CFR section 888.3350)

#### Equivalent Device

This cemented hip stem is equivalent in design, materials, strength and indications to the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (K991227 - Encore Orthopedics), the Synergy stem (K990369 - Smith & Nephew) and the Summit stem (K013352 - J&J/DePuy).

#### Device Description

This is a cemented hip stem fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799. It has a trapezoidal proximal body cross section, tapering both lateral to medial and proximal to distal. The proximal body has a cobra flange along the lateral aspect that helps to apply compressive stresses to the cement. It has a "standard 12/14" Morse type taper to accept modular heads and a neck/shaft angle of 129°. It also has a calcar collar that extends medially only.

The distal stem is conical in shape, tapering proximal to distal end the stem quickly necks down to accept a PMMA distal centralizer is four flanged and is utilized to assure that the distal stem is centered in the femoral canal and a uniform cement mantle is obtained. The distal stem bas four flutes or grooves that increases torsion stability when implanted in cement.

Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.

# Intended Use

The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural fead has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

#### Summarv Nonclinical Tests

Engineering analysis indicates that this stem will withstand cyclic loads similar to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

PLUS Orthopedics c/o Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd Round Rock, TX 78681

Re: K031165

Trade/Device Name: Plus Orthopedics Cemented Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 10, 2003 Received: April 14, 2003

Dear Mr. Webb:

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

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forth in the quality systems (OS) 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Miriam C. Provost

for 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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KOSTIFFE 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PLUS Orthopedics Cemented Hip Stem

Indications for Use:

# Cemented Hip Stem Indications for Use

The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Miriam C Provost

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

510(k) Number K031165

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