MODULAR REPLACEMENT SYSTEM CEMENTED STEMS

K040749 · Howmedica Osteonics Corp. · KRO · Jun 17, 2004 · Orthopedic

Device Facts

• Record ID: K040749
• Device Name: MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
• Applicant: Howmedica Osteonics Corp.
• Product Code: KRO · Orthopedic
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular Replacement System (MRS -- found substantially equivalent in K952970, K965164 and K972 al) has been successfully used in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.

Device Story

Modular Replacement System (MRS) Cemented Stems are orthopedic implants used for segmental bone replacement in the proximal femur, distal femur, or proximal tibia. Stems are available in standard and small configurations, with straight or curved geometries and optional porous coating. Devices are implanted by orthopedic surgeons in clinical settings to address bone loss from tumor resection, trauma, or revision of failed prostheses. Stems utilize a Morse taper (2 degrees 52 minutes) to connect to other MRS/GMRS system components and are secured using bone cement. A recessed hole at the distal end allows for an optional cement centralizer. By providing structural support and restoring skeletal integrity, the system aims to improve patient mobility and function following extensive bone loss.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by engineering analysis.

Technological Characteristics

Cemented femoral/tibial stems; Morse taper connection (2 degrees 52 minutes); available in straight/curved configurations; lengths 102mm-203mm; distal diameters 8mm-17mm; seat diameters 24mm-36mm; optional porous coating; intended for use with bone cement.

Indications for Use

Indicated for femoral and/or proximal tibial replacement in patients with extensive bone loss due to trauma, failed previous prosthesis, or tumor resection. Contraindicated in patients with pathological fracture, overt infection, inopportune biopsy incision, rapid disease progression, or neuromuscular disorders creating unacceptable risk of instability or fixation failure.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• MRS Proximal Femoral Stems (K952970)
• Distal Femoral Stems (K965164)
• Proximal Tibial Stems (K972...)

Submission Summary (Full Text)

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Modular Replacement System Cemented Stems Confidential

510(k) Premarket Notification

ん

| Confidential | | K040749<br>page 1 of |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| JUN 17 2004 | 510(k) Summary | |
| Submission Information | | |
| Name and Address of Sponsor: | Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, New Jersey 07430 | |
| For Information contact: | Margaret F. Crowe<br>Regulatory Affairs Consultant<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, New Jersey 07430 | |
| Device Identification | | |
| Proprietary Name: | Modular Replacement System Cemented Stems | |
| Common Name: | Proximal Femoral Replacement<br>and<br>Modular Rotating Hinge Knee | |
| Classification Name and Reference: | Prosthesis, Hip, Semi-constrained Metal/Polymer<br>Porous Uncemented<br>21 CFR §888.3358<br>and<br>Knee joint femorotibial metal/polymer<br>constrained cemented prosthesis<br>21 CFR §888.3510 | |
| Proposed Regulatory Class: | Class II | |
| Device Product Code: | OR(87) LPH and KRO | |

### Intended Use

The Modular Replacement System (MRS -- found substantially equivalent in K952970, K965164 and K972 al) has been successfully used in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.

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Modular Replacement System Cemented Stems ____________________________________________________________________________________________________________________________________ Confidential

page 20f

040749

It is the intention of Howmedica Osteonics Corp. to expand the indications for use of the standard Proximal/Distal Femoral Stems to include use in the proximal tibia. In order to accomplish this change, the product label for these stems will change to "Cemented Stem". In addition, a minor design change is being made - the diameter at the base of the male taper of these stems will be changed from 28mm to provide a minimal transition when assembled to a variety of components.

Likewise, it is the intention of Howmedica Osteonics Corp. to expand the indications for use for the Small Distal Femoral Stems to include use in the proximal tibia, and to expand the clinical situations where this product can be used to include failed previous prosthesis and trauma. In order to accomplish this change, the product label description for these devices will be changed to "Small Cemented Stem". In addition, the diameter at the base of the male taper of these small stems will be changed from 24mm to provide a minimal transition when assembled to a variety of components.

All of the stems currently cleared for use in the distal femur would also be available for use in the proximal tibia. All of these stems would be indicated for use with the other segments of the Modular Replacement System (MRS) and/or Global Modular Replacement System (GMRS™) in the treatment of extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These stems are intended for use with bone cement.

Specific indications for these MRS Cemented Stems are discussed below:

#### Indications

Femoral and/or proximal tibial replacement due to

- . Trauma
- Failed previous prosthesis .
- Tumor resection .

#### Contraindications

- As related to Bone Tumors A.

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510(k) Premarket Notificati

Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication. Examples of such conditions include:

- pathological fracture; .
- overt infection; .
- inopportune placement of biopsy incision; and, .
- rapid disease progression beyond a respectable margin. .
- As related to Failed Previous Prosthesis and Trauma B.
- Any active or suspected latent infection in or about the hip joint. .
- Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
- Bone stock compromised by disease, infection, or prior implantation that cannot . provide adequate support and fixation of the prosthesis.

## Device Description

The following configurations of MRS Cemented Stems will be available:

## Standard Cemented Stems:

- Straight stem with 40mm porous coated body distal diameters/seat diameters are ◆ 11mm/24mm, 13mm/28mm, 15mm/32mm, 17mm/36mm - 127mm in length
- Straight stem without body distal diameters/seat diameters are 11mm/24mm, . 13mm/28mm, 15mm/32mm, 17mm/36mm - 127mm in length
- Curved stem with 40mm porous coated body distal diameters/seat diameters are . 11mm/24mm, 13mm/28mm, 15mm/32mm, 17mm/36mm - 127mm in length
- Curved stem without body distal diameters/seat diameters are 11mm/24mm, . 13mm/28mm, 15mm/32mm, 17mm/36mm - 127mm in length
- Curved stem with 40mm porous coated body distal diameters/seat diameters are . 11mm/24mm, 13mm/28mm, 15mm/32mm, 17mm/36mm - 203mm in length

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40749 page 4 of 4

Modular Replacement System Centeried Sions ___________________________________________________________________________________________________________________________________ Confidential

510(k) Premarket Notification

- Curved stem without body distal diameters/seat diameters are 11mm/24mm, . 13mm/28mm, 15mm/32mm, 17mm/36mm - 203mm in length
Standard cemented femoral stems will be used in the proximal femur, distal femur, and proximal tibia. These stems may be used with the standard and small distal femoral component, and standard and small proximal tibial component of the MRS and/or GMRS™ systems.

# Small Cemented Stems:

- Straight stem with 40mm porous coated body distal diameters/seat diameters are . 8mm/24mm, 9mm/24mm, 10mm/24mm - 102mm in length
- Straight stem without body distal diameters/seat diameters are 8mm/24mm, . 9mm/24mm, 10mm/24mm - 102mm in length
- Curved stem with 40mm porous coated body distal diameters/seat diameters are . 8mm/24mm, 9mm/24mm, 10mm/24mm - 102mm in length
- Curved stem without body distal diameters/seat diameters are 8mm/24mm, . 9mm/24mm, 10mm/24mm - 102mm in length

These stems may be used with the small Distal Femoral component, and small proximal tibial component of the MRS and/or GMRSTM systems.

All of the stems utilize a Morse taper to connect to the proximal femoral/distal femoral or proximal tibial components. The taper angle is 2 degrees 52 minutes. At the distal end of the larger stems is a recessed hole to allow the optional use of a cement centralizer.

Equivalent products include the existing MRS Proximal Femoral Stems, Distal Femoral Stems and Proximal Tibial Stems.

An engineering analysis was presented to support a claim of substantial equivalence to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K040749

Ko40747
Trade/Device Name: Modular Replacement System (MRS) Cemented Stems Regulation Number: 21 CFR 888.3510 Regulation Name: 21 CFTC 000.5010
Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: March 19, 2004 Received: March 23, 2004

Dear Ms. Crowe:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becarel be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreation of tegally to regists of the Medical Device Amendments, or to conninered pror to rilly 20, 1978, is accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Cosmetic Act (710) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provision 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 rr your device is olassified (600 world). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and the may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri 8 issuance or with other requirements of the Act that I DIT has made a acterimations administered by other Federal agencies. You must of any it catal statuter and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rail 607); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality bytellis (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Margaret F. Crowe

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maileans your device of your device to a legally premaired notincation. The PDF intellig of the mailing of 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 If you desire spocitie acritor for your 201) 594-4659. Also, please note the regulation entitled, Connect the Office of Court Courtemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Sincerely yours,

Mark A. Mulkerson

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): _ KOYO749

Device Name:___Modular Replacement System (MRS) Cemented Stems

Femoral and/or proximal tibial replacement due to

- Trauma .
- Failed previous prosthesis .
- Tumor resection .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Millheim

ថ្វើក្រោ sion Division of General, Restorative, and Neurological Devices

KO4 6799 510(k) Number_