MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

K964350 · Intermedics Orthopedics · JDI · Jan 16, 1997 · Orthopedic

Device Facts

• Record ID: K964350
• Device Name: MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
• Applicant: Intermedics Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: Jan 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include: metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; and, severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacement(s) of the proximal and/or distal femur.

Device Story

Modular orthopedic prosthesis system for proximal, distal, or total femur replacement; indicated for oncology cases or severe trauma/revision requiring extensive bone resection. System components include proximal femoral replacements (with/without greater trochanter design), distal femoral replacements (hinge-type mechanism allowing 15-degree rotation), intramedullary stems with Cancellous Structured Titanium (CSTi), femoral segments, and all-poly patella. Used by orthopedic surgeons in clinical/surgical settings. Modularity allows intraoperative length adjustment and restoration of bone loss. Distal components require cement; proximal components allow press-fit or cement. Device restores joint function and structural integrity in patients with significant bone loss.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, intended use, and mechanical comparison to predicate devices.

Technological Characteristics

Modular femoral/tibial prosthesis system. Materials include Cancellous Structured Titanium (CSTi) for I/M stems and all-polyethylene for patellar components. Features hinge-type knee mechanism allowing 15-degree internal/external rotation. Proximal components support press-fit or cemented fixation; distal components are cemented. Modular design allows for variable femoral resection lengths.

Indications for Use

Indicated for patients requiring extensive resection and replacement of proximal, distal, or total femur due to metastatic bone disease (e.g., osteosarcoma, chondrosarcoma, giant cell tumors), revision surgery, or severe inflammatory/non-inflammatory degenerative joint disease.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Segmented Oncology System (S.O.S.) Proximal Femur (Wright Medical Technology, Inc.)
• MP Reconstruction Prosthesis (Waldermar Link)
• Noiles Total Knee Prosthesis (Joint Medical Products Corporation)
• Kinematic II Rotating Hinge (Howmedica, Inc.)

Submission Summary (Full Text)

{0}

JAN-14-97 TUE 10:42
INTERMEDIOS ORTHOPELOUS
FAX NO. 15.2432323
P. 02
JAN 16 1997
K964350

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Modular Options for Severe bone loss and Trauma (MOST) System.

| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
[phone] |
| --- | --- |
| Date: | January 10, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented prosthesis 21CFR 888.3510
Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis 21CFR 888.3353 |
| Common/Usual Name: | Hinge Knee for Total Knee Replacement/Hip Stem for Total Hip Replacements/Total Hip and Knee Replacement |
| Trade/Proprietary Name: | Modular Options for Severe bone loss and Trauma (MOST) System |

## PRODUCT DESCRIPTION

The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this 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 those cases where no part of the femur can be salvaged. The components of the MOST System include:

- the proximal femoral replacement that is available in two designs to address the presence or absence of the greater trochanter, with suture holes for soft tissue attachment;
- the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, allowing 15 degrees of internal and external rotation;
- intramedullary (I/M) stems with Cancellous Structured Titanium™ (CSTi™) and femoral segments which will be used in conjunction with the proximal and distal replacements, and,
- an all-poly patella.

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JAN-14-97 TUE 10:42
INTERMEDICS ORTHOPEDICS
FAX NO. 15124329291
P. 03

# DIAGNOSTIC INDICATIONS

This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include:

- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur; and,
- severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacement(s) of the proximal and/or distal femur.

# SUBSTANTIAL EQUIVALENCE

The MOST System is substantially equivalent to products offered by Wright Medical Technology, Inc., Waldermar Link, Joint Medical Products Corporation and Howmedica, Inc. The Segmented Oncology System (S.O.S.™) Proximal Femur (Wright Medical) and the MP Reconstruction Prosthesis (Link) are both modular stem designs which allow for necessary length adjustment. This provides surgeon's with intraoperative flexibility in a variety of clinical situations.

The Hinge-Type Knee of the MOST System is substantially equivalent to the Noiles Total Knee Prosthesis (Joint Medical Products Corporation) and the Kinematic II Rotating Hinge (Howmedica).

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