MODULAR PLUS HIP STEM

K032709 · Plus Orthopedics · LWJ · Sep 23, 2003 · Orthopedic

Device Facts

• Record ID: K032709
• Device Name: MODULAR PLUS HIP STEM
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.

Device Story

Modular PLUS Revision Stem is a cementless, two-part modular hip prosthesis consisting of a distal anchorage module and a proximal revision module. Components connect via a multi-stage tapered coupling secured by a cylindrical screw. Proximal module features a 12/14 taper for modular head attachment. Device is implanted by orthopedic surgeons in a clinical/surgical setting to replace damaged femoral bone structure. Engineering analysis confirms bending stresses in the taper connection are reduced in the modified longer modules compared to the predicate. Device provides structural support for hip joint reconstruction in patients with extensive femoral bone damage.

Clinical Evidence

Bench testing only. Engineering analysis performed to evaluate bending stresses in the taper connection of the modified modules.

Technological Characteristics

Material: Ti-6Al-4V alloy (ASTM F136). Surface: Grit blasted with corundum (roughness 4-6um). Design: Two-part modular cementless hip stem; distal anchorage and proximal revision modules; multi-stage tapered coupling; cylindrical screw fixation; 12/14 taper for modular heads. Dimensions: Added proximal modules (AX, BX, CX) with increased lengths (15.4mm, 18.7mm, 22.7mm respectively) compared to predicate.

Indications for Use

Indicated for patients with femoral fractures requiring cementless fixation where bone damage necessitates anchoring in the distal half of the 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

• Modular PLUS stem (K030971)

Submission Summary (Full Text)

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2 3 2003

510(k) Summary

**Date**
August 28, 2003

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

### Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name

Hip stem

## Classification name

Prosthesis, hip, semi-constrained, metal/polymer, uncemented per 21 CFR Sec. 888.3360

#### Equivalent Device

The modifications to this device continue to be equivalent in design, fundamental scientific technology, indications and material to the Modular PLUS stem cleared on K030971.

## Device Description

The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw.

The proximal module has a standard 12/14 taper to accept modular heads.

The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.

This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.

#### Intended Use

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.

#### Summary of Technological Characteristics Compared to Predicate Device

The modifications to this device continue to be equivalent in design, fundamental scientific technology, indications and material to the Modular PLUS stem cleared on K030971.

#### Summary Nonclinical Tests

Engineering analysis shows that the bending stresses in the taper connection are less for the modified, longer modules.

032709
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle, which is the symbol of the HHS.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032709

Trade/Device Name: Modular PLUS Revision Stem Regulation Numbers: 21 CFR 888.3360 Regulation Names: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ Dated: August 28, 2003 Received: September 2, 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 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 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 N. Milkeson

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): _ K032709

Device Name:

Indications for Use:

# Modular PLUS Revision Stem Indications for Use

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional format 1-2-96)

for Mark A. Milken

ivision of General, Restorative and Neurological Devices

(k) Number K032709