MOST OPTIONS SYSTEM

K013031 · Sulzer Orthopedics, Inc. · KRO · Dec 7, 2001 · Orthopedic

Device Facts

• Record ID: K013031
• Device Name: MOST OPTIONS SYSTEM
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: KRO · Orthopedic
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MOST System is intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Proximal femoral replacement components are available for press-fit or cemented applications. Components used for replacement of the distal femur and proximal tibia are available in a variety of sizes. Specific diagnostic indications for use of the MOST include: - metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) and trauma requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; - patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory (IJD), e.g. rheumatoid arthritis, requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and - revision cases requiring resection(s) and replacement(s) of the proximal, distal or total femur and/or proximal tibia.

Device Story

Modular orthopedic prosthesis system for extensive femoral/tibial resection and reconstruction; oncology and revision applications. Components include distal femoral replacements (condylar/hinged), proximal femoral replacements, proximal tibial replacements, intramedullary stems with Cancellous Structured Titanium (CSTi) coating, and all-poly patella. System utilizes hinge-type mechanism for femorotibial articulation. Implantation performed by orthopedic surgeons in clinical/surgical settings. Modularity allows intraoperative adjustment for bone loss. Provides structural restoration of limb; enables joint function in patients with severe bone loss or malignancy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Modular orthopedic prosthesis; materials include metal (CSTi coated titanium) and polymer components. Features hinge-type articulation mechanism, intramedullary stems, and modular segments for varying resection lengths. Designed for cemented or press-fit application.

Indications for Use

Indicated for patients requiring extensive resection and replacement of proximal, distal, or total femur and/or proximal tibia due to metastatic bone disease (e.g., osteosarcoma, chondrosarcoma, giant cell tumor), trauma, non-inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), or revision surgery.

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

• Sulzer Orthopedics MOST™ System
• Johnson & Johnson S-ROM® Noiles™ Rotating Hinge Knee System
• Howmedica Osteonics® Modular Rotating Hinge Knee (MRS)

Submission Summary (Full Text)

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K013031
page 1 of 2

#### 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics MOST Options™ System

| Manufacturer: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | September 7, 2001 |
| Contact Person: | Frances E. Harrison, RAC<br>Senior Regulatory Affairs Specialist |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented<br>prosthesis - 21 CFR Part 888.3510 |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis - 21 CFR Part 888.3353 |
| Common/Usual Name: | Total Hinged Knee for Total Knee Replacement<br>Femorotibial Prosthesis |
| Trade/Proprietary Name: | MOST Options™ System (MOST) |

### PRODUCT DESCRIPTION

The MOST Options System (MOST) is used for the replacement of the proximal, distal or total femur and/or the proximal tibia. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system can be used where extensive femoral and/or tibial resection and restoration is required (e.g., oncology cases). Modularity of the system allows for the resection of varying amounts of the femur and the proximal tibia (and patella, if necessary) before implantation. A total replacement is possible in cases where no part of the femur can be salvaged. Moreover, the system provides additional options for revision or severe bone loss of the tibia. The components of the MOST System include:

- . a distal femoral replacement (Condylar End or Hinged Femur) which mates with a tibial component via a hinge type mechanism (Hinge-Kit or 4mm Hinge Kit):
- a proximal femur replacement that is available in two designs to address the . presence or absence of the greater trochanter;
- intramedullary (I/M) stems with Cancellous Structured Titanium™ (CSTi™) and . MOST segments which will be used in conjunction with the proximal and distal femoral replacements, the Proximal Tibia and the MOST Revision Stem Adapter;
- an all poly patella; ●

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- a proximal tibia replacement (Proximal Tibia or Hinged Tibia) which mates with the . Proximal Tibia Insert and Hinged Tibia Insert, respectively and features a distal female taper for attachment of a MOST Revision Stem Adapter, Sulzer Revision Stems or Hinged Tibia Stem Plug (Hinged Tibia only);
- femoral and tibial spacers for use in conjunction with the Hinged Femur and Hinged . Tibia, respectively to augment uni-compartmental or bi-compartmental defects; and
- revision stem adapter with and without CSTi coating used to convert the MOST . taper to the Sulzer taper.

## SPECIFIC DIAGNOSTIC INDICATIONS

Components of the MOST System are intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use of the MOST include:

- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors ) and trauma requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
- patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis and inflammatory (IJD), e.g. rheumatoid arthritis, requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
- revision cases requiring resection(s) and replacement(s) of the proximal, distal or total . femur and/or proximal tibia.

#### SUBSTANTIAL EQUIVALENCE

The MOST Options System is similar to the following commercially available devices in terms of materials, general design features, and intended uses:

- Sulzer Orthopedics MOST™ System .
- Johnson & Johnson S-ROM® Noiles™ Rotating Hinge Knee System .
- Howmedica Osteonics® Modular Rotating Hinge Knee (MRS) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Ms. Frances E. Harrison, RAC Senior Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K013031

Trade/Device Name: MOST Options System Regulation Number: 21 CFR 888.3510; 21 CFR 888.3353 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: KRO, LZO Dated: September 7, 2001 Received: September 10, 2001

Dear Ms. Harrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your becemined the device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the enorosals) to 10gains actual device Amendments, or to commerce prior to rias 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercesses maines 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 If your device is olassined (600 a00 voyals. Existing major regulations affecting your device can may be subject to back as back as a submit ons, 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 I lease of advised that I Drivisan that your device complies with other requirements of the Act that I Dr Has made a wond regulations administered by other Federal agencies. You must of any I vith 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 OF IT in the quality systems (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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premaired notification. The PDF intelling of easification 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 and IT you desire specific ad roo for your witto diagnostic devices), please contact the Office of additionally 21 CHC Far 007.10 Tor questions on the promotion and advertising of Compliance at [phone] of Compliance at [phone]. Also, please note the your devices, proced volisbranding by reference to premarket notification" (21CFR Part 807.97). regulation on this contrass on your responsibilities under the Act may be obtained from the Outcr general miormation turers, 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 McMillan

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): | K013031 |
|---------------------------|-------------|
| Device Name: | MOST System |

# Indications for Use:

The MOST System is intended to replace the proximal, distal or total femur and/or The MOST System is intendou to rep that require extensive resection and the proximal tibla, especially in odoco the rouve also include replacement of the restoration. Replacement of the usities with neelssary Proximal femoral
proximal tibia and possible resurfacing of the patella, if necessary Proximal femoral proximal tible and possible for press-fit or cemented applications.
replacement components are available for press-fit or cement within are replacement components are available in a proximal tible are Components used for replacemont of the distances for use of the MOST include:

- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, 1. metastatic discases (c.g., octoboarders), and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
- patient conditions of non-inflammatory degenerative joint disease (NIDJD), 2. patient conditions of non inflammatory and inflammatory (IJD), e.g. rheumatoid e.g., avascular necrosis, octobar.mn.org.inn.its) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
- revision cases requiring resection(s) and replacement(s) of the proximal, distal 3. or total femur and/or proximal tibia.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

for Mark N. Melkerson
(Division Sign-Off)
Division of Ge
and Neurologic Devices

510(k) Number K013031

Prescription Use X OR Over-the Counter Use **__**

(Optional Format 1-2-96)