PATELLOFEMORAL JOINT PROSTHESIS

K962190 · Intermedics Orthopedics · KRR · Oct 28, 1996 · Orthopedic

Device Facts

• Record ID: K962190
• Device Name: PATELLOFEMORAL JOINT PROSTHESIS
• Applicant: Intermedics Orthopedics
• Product Code: KRR · Orthopedic
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include: 1. Patients with osteoarthritis in the distal femur and patella. 2. Patients with a history of patellar dislocation or patellar fracture. 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

Device Story

Patellofemoral Joint Prosthesis is a cemented orthopedic implant designed for patellofemoral arthroplasty. The device replicates the anatomic features of the femoral patellar groove; it features a highly polished concave gliding anterior surface to facilitate patellar tracking, matching the geometry of the Natural Knee II System. The posterior surface includes two fixation pegs for stability and a grit-blasted surface (175-225 µinch roughness) to enhance interdigitation with bone cement. The device is asymmetric, available in left and right configurations, and is implanted by an orthopedic surgeon in a clinical/OR setting to restore joint function and alleviate pain in patients with degenerative or traumatic patellofemoral conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Material: Cast CoCr Alloy. Fixation: Cemented with two posterior pegs. Surface: Grit-blasted posterior (175-225 µinch roughness) and polished concave anterior gliding surface. Configuration: Asymmetric (left/right specific).

Indications for Use

Indicated for patients with osteoarthritis of the distal femur and patella, history of patellar dislocation or fracture, or failed prior surgical interventions (e.g., arthroscopy, tibial tubercle elevation, lateral release) resulting in persistent pain, deformity, or dysfunction.

Regulatory Classification

Identification

A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” (vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and (viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”

Predicate Devices

• Bechtol Patello-Femoral Joint Replacement (Preamendment Status)
• Type I Femoral Component (Preamendment Status)
• Type II Femoral Component (Preamendment Status)
• Lubinus Total Patella Glide Femoral Component (Preamendment Status or 510(k) unknown)

Reference Devices

• Natural Knee II System (K936159)

Submission Summary (Full Text)

{0}

OCT-24-96 THU 10:53
INTERMEDICS ORTHOPEDICS
FAX NO. 15124329291
P.01
K962190
OCT 28 1996

510(k) Premarket Notification
Summary of Safety and Effectiveness
for the
Patellofemoral Joint Prosthesis

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Patellofemoral Joint Prosthesis.

Submitter:
Intermedics Orthopedics, Inc. (IOI)
9900 Spectrum Drive
Austin, Texas, 78717
Tel.: [phone]
Fax: [phone]

Contact Person:
Regarding this submission:
Name: Sam Mirza
Tel.: [phone]
Fax: [phone]

Official Correspondent
Name: Jacquelyn Hughes
Tel.: [phone]
Fax.: [phone]

Date: October 24, 1996

Proprietary name: Patellofemoral Joint Prosthesis
Common Name: Patellofemoral Joint Prosthesis

Classification name: Knee Joint patellofemoral polymer/metal semi-constrained cemented prosthesis, 21 CFR 888.3540, Class III, 87KRR

Predicate Devices:
The features employed by the Patellofemoral Joint Prosthesis are substantially equivalent to the features employed by the following predicate legally marketed devices:

- Bechtol Patello-Femoral Joint Replacement; Smith and Nephew Richards, Inc. (Preamendment Status);
- Type I Femoral Component; Smith and Nephew Richards, Inc. (Preamendment Status);
- Type II Femoral Component; Smith and Nephew Richards, Inc. (Preamendment Status);

{1}

OCT-25-96 FRI 10:23
INTERMEDICS ORTHOPEDICS
+4x 15.24-32228
F. 32

> Lubinus Total Patella Glide Femoral Component; Waldemar Link (510(k) number or Preamendment Status unknown to IOI).

## Device Description:

The design of the Patellofemoral Joint Prosthesis closely replicates the anatomic features of the patellar groove on a femur. In addition, the design of the highly polished concave gliding anterior surface of the Patellofemoral Joint Prosthesis is identical to the proximal anterior surface of the articulating geometry of the Natural Knee II System's femoral component which has been determined substantially equivalent by the FDA via 510(k) K936159. The highly polished concave gliding surface of the Patellofemoral Joint Prosthesis complements the design of the articulating geometry of the IOI's patella components for optimal patellar tracking.

The posterior surface of the Patellofemoral Joint Prosthesis employs two fixation pegs for enhanced stability of the prosthesis when cemented into the femur. In addition, the posterior surface of the Patellofemoral Joint Prosthesis employs a grit blasted roughened surface to facilitate interdigitation with bone cement. The roughness of the grit blasted surface ranges from 175 - 225 $\mu$inch.

The Patellofemoral Joint Prosthesis is an asymmetrically designed component and, therefore, is available in both left and right configurations.

## Intended Use:

The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include:

1. Patients with osteoarthritis in the distal femur and patella.
2. Patients with a history of patellar dislocation or patellar fracture.
3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

## Summary of Technological Characteristics:

A side by side tabular comparison of the characteristics of the Patellofemoral Joint Prosthesis to those of the currently marketed IOI and competitive devices follows:

{2}

OCT-24-96 THU 10:54
INTERMEDICS ORTHOPEDICS
FAX NO. 15124329291
P. 03

| Characteristics | Subject Device | Predictor Period | | | |
| --- | --- | --- | --- | --- | --- |
| | | Patello-remoral Joint Prosthesis | Bridal Patello-remoral Joint | Type I Femoral Component | Type II Femoral Component |
| Manufacturer | Intermedics Orthopedics, Inc. | Smith and Nephew Richards, Inc. | Smith and Nephew Richards, Inc. | Smith and Nephew Richards, Inc. | Waldemar Link |
| 510(k) No. | - | Preamend. | Preamend. | Preamend. | Preamend. or 510(k) status unknown |
| Application | Cemented | Cemented | Cemented | Cemented | Cemented |
| Material | Cast CoCr Alloy | Cast CoCr Alloy / Stainless Steel | Cast CoCr Alloy / Stainless Steel | Cast CoCr Alloy / Stainless Steel | Cast CoCr Alloy |
| Concave | Yes | Yes | Yes | Yes | Yes |
| Fixation pegs | Two | Three | One | Three | Three |
| Assymmetric | Yes | No | No | No | Yes |