PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT

K964395 · Hayes Medical, Inc. · LZO · Jan 27, 1997 · Orthopedic

Device Facts

• Record ID: K964395
• Device Name: PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
• Applicant: Hayes Medical, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PSI device is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture or the failure of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.

Device Story

Patient-specific hip femoral component; designed using patient CT or X-ray data to match natural femoral bone geometry; intended for uncemented total hip arthroplasty. Device manufactured within defined dimensional envelope parameters. Used by orthopedic surgeons in clinical settings to replace damaged hip joints. Provides improved fit and fill of the femoral canal compared to standard hip stems. Benefits include anatomical customization for patients with specific bone geometry needs. Fatigue performance verified via engineering stress analysis and mechanical testing on representative stems.

Clinical Evidence

Bench testing only. Engineering stress analysis performed on the design envelope to ensure fatigue performance comparable to standard hip stems. Mechanical testing conducted on a representative PSI stem to verify stress analysis calculations.

Technological Characteristics

Materials: Wrought or Forged Titanium (Ti-6Al-4V). Design: Patient-specific geometry within defined dimensional envelope (8mm-20mm distal diameter, 90mm-300mm length). Features: Collar, distal flutes. Surface treatments: Smooth or grit blasted. Sterilization: Sterile and non-sterile options.

Indications for Use

Indicated for patients requiring total hip arthroplasty (THA) due to degenerative joint disease, fracture, or failure of previous arthroplasty. Specifically for patients benefiting from a femoral component matched to natural femoral bone geometry. Intended for uncemented use.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Patient Matched Implant (PMI) Hip Femoral Component (Biomet, Inc.)

Reference Devices

• Techmedica CAD/CAM Custom Hip (Techmedica, Inc.)
• Biopro DRG Custom Hip Replacement System (Biopro, Inc.)

Submission Summary (Full Text)

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JAN 27 1997
K964395

# Premarket Notification
510(k) Summary

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act (SMDA) of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) Summary for the Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component.

## Submitter:
Kairos™ Orthopaedics
819 Striker Avenue, Suite 10
Sacramento, California 95834
Telephone: [phone]
Fax: [phone]

## Date:
November 1, 1996

## Contact Person:
Brian Cleary
Director, Regulatory Affairs

## Classification Name:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)

## Common Name:
Patient Matched Hip Stem

## Trade/Proprietary Name:
Patient Specific Implant (PSI) Hip Femoral Component

## Product Code:
87 LZO

## Device Description:
The Kairos™ Orthopaedics Patient Specific Implant (PSI) hip femoral component is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient to patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.

The PSI device is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture or the failure of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.

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# Substantial Equivalence:

Several commercially available standard line hip products are substantially equivalent to the Kairos™ Orthopaedics' PSI hip femoral component with respect to overall design, materials, intended use, and sterilization methods. Additionally, the manufacturing methods and applied surface treatments are substantially the same as those used in the production of a wide range of currently marketed standard line hip products.

It is our understanding that other anatomically based hip stems have received 510(k) clearance in the past, including the following:

1. Patient Matched Implant (PMI) Hip Femoral Component
Biomet, Inc. (Warsaw, Indiana)

2. Techmedica CAD/CAM Custom Hip
Techmedica, Inc. (Camarillo, California)

3. Biopro DRG Custom Hip Replacement System
Biopro, Inc. (Port Huron, Michigan)

Of these, Biomet's Patient Matched Implant (PMI) is the most similar and is still presently marketed. Biomet's PMI hip stem is also a patient matched hip stem which uses patient data to design and manufacture a hip stem to match a particular patient's naturally occurring bone geometry. Due to the similarities in the general device design concept, Kairos™ Orthopaedics believes that the Biomet PMI stem is ideal for comparison to demonstrate the substantial equivalence of Kairos™ Orthopaedics' PSI stem. The table on the following page summarizes these feature comparisons.

Additionally, an engineering stress analysis was performed on the envelope of design parameters to ensure fatigue performance of the PSI femoral component comparable to a clinically proven standard hip stem. Mechanical testing performed by Kairos™ Orthopaedics on a representative PSI stem verified these stress analysis calculations.

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Feature comparisons between the Kairos™ Orthopaedics PSI hip femoral component and Biomet, Inc. PMI hip femoral component. Differences are indicated in bold print.

| Characteristics | Subject Device
Kairos™ Orthopaedics
Patient Specific Implant (PSI) | Predicate Device
Biomet, Inc.
Patient Matched Implant (PMI) |
| --- | --- | --- |
| Manufacturer | Kairos™ Orthopaedics | Biomet, Inc. |
| 510(k) Approved | - | Yes |
| Materials | Wrought or Forged Titanium (Ti-6Al-4V) | Wrought Cobalt Chromium (Co-Cr-Mo) or Wrought Titanium (Ti-6Al-4V) |
| Intended Use | Uncemented | Cemented/Uncemented |
| Patient Matched | Yes | Yes |
| Collar | Yes | Yes |
| Distal Flutes | Yes | Yes |
| Surface Treatments | • Smooth
• Grit Blasted | • Smooth
• Grit Blasted
• Plasma Sprayed Coating
• Ion Nitride (NTS) |
| Stem Length from
Resection Level | 90mm - 300mm | unknown |
| Distal Diameter | 8mm - 20mm | unknown |
| Patient Information | CT or X-Ray | CT or X-Ray |
| Sterilization Status | Sterile & Non-sterile | Sterile |