UNI HIP STEM

K024134 · Plus Orthopedics · LWJ · Jan 15, 2003 · Orthopedic

Device Facts

• Record ID: K024134
• Device Name: UNI HIP STEM
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Jan 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNI 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 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

UNI Hip Stem is a cementless, press-fit femoral component for total hip arthroplasty. Device features flat rectangular cross-sectional geometry to manage rotational stress and transmit load to the greater trochanter and calcar. Manufactured from Ti6Al4V titanium alloy with corundum-blasted surface for primary stability. Available in twelve sizes with 12/14 neck taper compatible with 22, 28, or 32mm metal or ceramic heads. Used by orthopedic surgeons in clinical settings to relieve hip pain and restore joint motion in patients with femoral head disease, trauma, or failed prior arthroplasty.

Clinical Evidence

Bench testing only. Fatigue testing performed in accordance with ISO 7206-4.

Technological Characteristics

Cementless femoral hip stem; material: Ti6Al4V titanium alloy (ASTM F136); surface finish: corundum-blasted; geometry: flat rectangular cross-section; interface: 12/14 neck taper; sizes: 12 variations; energy source: none (mechanical implant).

Indications for Use

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

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

• SL-PLUS Stem (K001942)

Submission Summary (Full Text)

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K 014/34 pg19/

# 510(k) Summary

Date December 13, 2002

#### Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121-2700

#### Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-4694

#### Common name

Press-fit hip stem

#### Classification name

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented (per 21 CFR section )

#### Equivalent Device

SL-PLUS Stem cleared on K001942.

#### Device Description

This stem has a flat rectangular cross sectional geometry that is intended to withstand rotational stress. The large proximal surfaces transmits stress to the greater trochanter and the arch of the calcar. This geometry achieves high primary stability and lays the foundation for good secondary stability.

This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.

# Intended Use

The UNI 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 previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

# Summary of Technological Characteristics Compared to Predicate Device

The UNI Stem is similar to the SL-PLUS Stem. Both stems have the same overall stem profile and are manufactured from similar titanium alloys (Ti6Al4V - UNI Stem & Ti6Al7Nb - SL-PLUS Stem). The indications for use are the same for both stems. The only difference are the minor change in material, removal of lateral suture holes from the SL-PLUS stem, and slightly smaller cross section and head offset for the Uni stem.

# Summary Nonclinical Tests

Fatigue testing per ISO 7206-4 was successfully performed.

JAN 1 5 2003

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

PLUS Orthopedics C/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681

Re: K024134 Trade/Device Name: UNI Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LWJ, JDI Dated: December 13, 2002 Received: December 16, 2002

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 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 - Mr. J. D. Webb

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 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,

Mark A. Millman

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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510(k) number (if known):_____________________________________________________________________________________________________________________________________________________

K 024134

Device Name: UNI Hip Stem

Indications for Use:

# UNI Hip Stem Indications for Use

The UNI 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.

Mark N Milkerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices 024134 510(k) Number_