MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)

K960626 · Intermedics Orthopedics · JDI · Apr 18, 1996 · Orthopedic

Device Facts

• Record ID: K960626
• Device Name: MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
• Applicant: Intermedics Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: Apr 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular Oncology System Technology (MOST) 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.

Device Story

Modular oncology prosthesis system; replaces proximal, distal, or total femur; includes proximal tibia and patella components. Components: proximal femoral replacement (with/without CSTi), intramedullary stems, distal femoral replacement with hinge-type knee mechanism, all-poly patella. Used in orthopedic oncology surgery; allows intraoperative length adjustment via modular segments. Provides structural restoration after extreme bone resection. Surgeon-operated in OR. Benefits: restores limb function/stability in patients with significant bone loss.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Modular orthopedic prosthesis. Materials: Cancellous-Structured Titanium (CSTi), metal, polymer. Components: proximal/distal femoral replacements, intramedullary stems, hinge-type knee mechanism, all-poly patella. Suture holes for soft tissue attachment. Mechanical assembly.

Indications for Use

Indicated for patients requiring extreme femoral resection and restoration, typically oncology cases, involving proximal, distal, or total femur replacement, including proximal tibia and patella resurfacing as needed.

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)
• MP Reconstruction Prosthesis (Link)
• Noiles Total Knee Prosthesis (Joint Medical Products Corporation)
• Kinematic II Rotating Hinge (Howmedica)

Submission Summary (Full Text)

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K960626

# 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 Oncology System Technology (MOST).

Submitter: Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
[phone]

Date: February 12, 1996

Contact Person: Jacquelyn Hughes
Regulatory Affairs Manager

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 Oncology System Technology (MOST)

## PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE

The Modular Oncology System Technology (MOST) 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. The components of the MOST include:

- a proximal femoral replacement available with or without Cancellous-Structured Titanium™ (CSTi™),
- suture holes on the Proximal Femur provide for soft tissue attachment, if necessary,
- intramedullary stems with CSTi and femoral segments which will be used in conjunction with the proximal and distal replacements,
- the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, and
- an all-poly patella.

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The Modular Oncology System Technology 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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