GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT

K031480 · Howmedica Osteonics Corp. · KRO · Jul 31, 2003 · Orthopedic

Device Facts

• Record ID: K031480
• Device Name: GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
• Applicant: Howmedica Osteonics Corp.
• Product Code: KRO · Orthopedic
• Decision Date: Jul 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS™ Pediatric Tibial Bearing Component are listed below:

Device Story

Single-use, stemmed tibial bearing component; mates distal femoral components of GMRS or MRH systems to pediatric all-polyethylene tibial components. Connects via bushings, axle, and locking bumper. Designed for smaller bone structures or skeletally immature patients. Implanted using bone cement. Used in orthopedic oncology or limb salvage surgery. Provides structural replacement of resected bone; restores joint function. Surgeon-operated in clinical/OR setting.

Clinical Evidence

Bench testing only. Finite element analysis (FEA) was used to support the claim of substantial equivalence.

Technological Characteristics

Stemmed tibial bearing component; metal/polymer construction; modular design; connects via bushings, axle, and locking bumper. Designed for cemented fixation. Dimensions reduced compared to MRH XS/XL components. Single-use.

Indications for Use

Indicated for replacement of distal femur and/or proximal tibia in oncology cases or limb salvage procedures (severe trauma, failed previous prosthesis) requiring radical bone resection. Intended for patients with smaller bone structure or skeletally immature patients. Contraindicated in cases of local/distant tumor spread, pathological fracture, overt infection, poor biopsy incision placement, rapid disease progression, or neuromuscular disorders creating risk of instability/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 Pediatric Tibial Bearing Component
• MRH Crossover Tibial Bearing Component

Submission Summary (Full Text)

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K031480 - Page 1 of 3

# JUL 3 1 2003

#### 510(k) Summary

| Submission Information | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Name and Address of Sponsor: | Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401 |
| For Information contact: | Margaret F. Crowe<br>Regulatory Affairs Consultant<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, NJ 07401 |
| Device Identification | |
| Proprietary Name: | Global Modular Replacement System Pediatric<br>Tibial Bearing Component |
| Common Name: | Modular Rotating Hinge Knee System |
| Classification Name and Reference: | Knee joint femorotibial metal/polymer<br>constrained cemented prosthesis<br>21 CFR §888.3510 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR(87) KRO |

### Intended Use

The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS™ Pediatric Tibial Bearing Component are listed below:

## Indications

Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where

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radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is

## Contraindications

- A. As related to Bone Tumors
intended to be implanted using bone cement.

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. .
- B. As related to Failed Previous Prosthesis and Trauma
- Any active or suspected latent infection in or about the affected 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 GMRS™ Pediatric Tibial Bearing Component is a single use device that is available in one size. The GMRS™ Pediatric Tibial Bearing Component is designed to mate with the all sizes of the femoral components of the GMRS™ or the MRH systems, and the MRS pediatric all poly tibial components. The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set

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of bushings and an axle. A bumper locks this assembly. In terms of dimensions, the subject The GMRS™ Pediatric Bearing has a smaller distal stem diameter, and reduced anterior-posterior and medio-lateral dimensions when compared to the MRH XS/XL Tibial Bearing Component. These reduced dimensions are identical to those seen in the MRS Pediatric Tibial Bearing Component.

Equivalent products include the MRS Pediatric Tibial Bearing Component (Howmedica Osteonics Corp.) and the MRH Crossover Tibial Bearing Component (Howmedica Osteonics Corp.).

Finite element analysis (FEA) was presented to support a claim of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2003

Mr. William J. Cymbaluk Vice President, Quality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401

K031480 Re:

Device Name: Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: May 9, 2003 Received: May 12, 2003

Dear Mr. Cymbaluk:

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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Page 2 - Mr. William J. Cymbaluk

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,

Sincerely yours,

Mark N. Milliken

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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GMRS™ Pediatric Tibial Bearing Component Confidential

510(k) Premarket Notification

510(k) Number (if known): K 03 (480

GMRS™ Pediatric Tibial Bearing Component Device:

The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS"" Pediatric Tibial Bearing Component are listed below:

#### Indications

Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

# Contraindications

- As related to Bone Tumors A.
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. .
- B. As related to Failed Previous Prosthesis and Trauma

for Mark H. Millener

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

510(k) Number K 031480

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- Any active or suspected latent infection in or about the affected 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR 801.109)

Over-the Counter-Use

Mark A. Melkers

(Division Sign-Off) eneral. Restorative Division o and Neurological Devices 031486

510(k) Number -