OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM

K962152 · Osteonics Corp. · JWH · Aug 14, 1996 · Orthopedic

Device Facts

• Record ID: K962152
• Device Name: OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
• Applicant: Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 14, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure. Ligamentous instability requiring implant bearing surface geometries with increased constraint. Absent or non-functioning posterior cruciate ligament.

Device Story

Total knee replacement system for cemented application; replaces articulating surfaces of distal femur, tibia, and patella. Femoral components (cobalt chromium alloy) available with grit-blasted, waffle, or porous-coated surfaces; optional nitrogen ion implantation. Tibial components (UHMWPE) include all-polyethylene version or bearing inserts for metal trays; feature posteriorly sloping eminence and keeled post for constraint. Patellar components (UHMWPE) available in dome configurations. Used by orthopedic surgeons in clinical settings to restore knee function and stability in patients with severe joint disease or ligamentous deficiency. System provides load transfer and range of motion approximating natural knee anatomy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Cobalt chromium alloy (femoral), UHMWPE (tibial/patellar). Fixation: Cemented. Design: Posteriorly stabilized, semi-constrained. Femoral surface options: grit-blasted, waffle, MicroStructured porous coating, nitrogen ion implantation. Tibial features: radiographic locator wire, keeled post. Patellar features: three-peg fixation, dome geometry.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of failed knee replacement, ligamentous instability, or absent/non-functioning posterior cruciate ligament.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Osteonics Series 7000 Total Knee Primary Posteriorly Stabilized Femoral Components
• Osteonics Series 7000 Total Knee Primary Posteriorly Stabilized All-Polyethylene Tibial Component
• Osteonics Series 7000 Total Knee Tibial Bearing Insert - P/S I Series
• Osteonics Series 7000 Total Knee Resurfacing Patellar Components

Reference Devices

• Osteonics Omnifit Total Knee Tibial Trays

Submission Summary (Full Text)

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AUG 14 1996

Osteonics® Scorpio Posteriorly Stabilized Total Knee System

510(k) Premarket Notification

K962152

# 510(K) PREMARKET NOTIFICATION

# SUMMARY OF SAFETY AND EFFECTIVENESS

# OSTEONICS® SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM

## Submission Information

Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900

Contact Person:
Donna S. Wilson
Regulatory Affairs Specialist

Date Summary Prepared:
June 3, 1996

## Device Identification

Proprietary Name:
Osteonics® Scorpio Posteriorly Stabilized Total Knee System

Common Name:
Knee Prosthesis

Classification Name and Reference:
Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis
21 CFR §888.3560

## Predicate Device Identification

Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are substantially equivalent to the Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized Femoral Components. The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is substantially equivalent to the Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized All-Polyethylene Tibial Component. The Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is substantially equivalent to the Osteonics® Series 7000 Total Knee Tibial Bearing Insert - P/S I Series. The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are substantially equivalent to the Osteonics® Series 7000 Total Knee Resurfacing Patellar Components.

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Osteonics® Scorpio Posteriorly Stabilized Total Knee System
510(k) Premarket Notification

# Device Description

## Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components

The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are fabricated from cobalt chromium alloy, and are intended for cemented application to replace the articulating surface of the distal femur. These posteriorly stabilized femoral components are utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.

The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available in right and left configurations, and with three different interior surface textures to supplement the cement fixation of the device: basic grit-blasted surface roughness, waffle pattern, and MicroStructured® porous coating. The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available either with or without nitrogen ion implanted bearing surfaces.

## Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component

The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is a one-piece total knee replacement tibial component, fabricated from ultra-high molecular weight polyethylene (UHMWPE). The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component, when used in conjunction with its mating Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Component, provides the constraint needed to compensate for an absent or incompetent posterior cruciate ligament.

The bearing surface of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component employs a single medial lateral (M/L) radius, and incorporates a posteriorly sloping, raised tibial eminence, a radiographic locator wire, and a swept back, keeled post. The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is intended for cemented fixation. Primary fixation is to be achieved through interface of the bone cement with the tibial post.

## Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert

The Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is fabricated from ultra-high molecular weight polyethylene (UHMWPE). This tibial bearing insert is assembled to the tibial tray component intraoperatively via a locking wire mechanism.

The articulating surface area of the Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is identical to that of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component.

## Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components

The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE), and are intended for cemented application

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Osteonics® Scorpio Posteriorly Stabilized Total Knee System
510(k) Premarket Notification

onto the surgically prepared posterior patella. They replace the patellar articulating surface of the knee joint and simulate the natural anatomy and function of the knee.

The articular geometry is designed with a single medial lateral (M/L) radius. The overall geometry essentially consists of an oval patellar button configuration with three fixation pegs in the anterior surface of the component. The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are available in three design configurations - Concentric Dome, Medialized Dome, and Superior-Medialized Dome.

## Intended Use

The indications for the use of these posteriorly stabilized total knee components, in keeping with those of other legally marketed Class II posteriorly stabilized total knee components, are as follows:

## Indications:

- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure.
- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.

## Statement of Technological Comparison

The Osteonics® Scorpio Posteriorly Stabilized Total Knee System components share the same materials, indications and intended use, surgical techniques, basic design features, and basic manufacturing methods of their respective predicate devices. These components are substantially equivalent to predicate devices by virtue of providing for cemented application of the femoral, patellar, and all-polyethylene tibial components, security of fixation, proper load transfer, and a biomechanical function and range of motion which approximate the normal knee when used in conjunction with each other and/or the associated Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit Total Knee Tibial Trays, as applicable. Although the articulating surfaces of the subject devices differ slightly from that of their predicate devices, applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs.

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