PEEK MILLED IMPLANTS

Derived from CT data for satisfying reconstructive results1, 2, *

PEEK MILLED IMPLANTS

OVERVIEW

INDICATIONS
Intended for replacement of bony voids in the cranial/craniofacial skeleton.

Features and Benefits

  • Better anatomic fit versus conventional fixation/reconstruction methods1, 2, *
  • Reduced operating time compared to traditional reconstruction methods that require extensive contouring1, 2, **
  • Satisfying aesthetic results for surgeon and patient1, 2, **
  • Suitable materials for definitive treatment
  • Any necessary modifications of a PEEK implant (e.g., drainage, monitoring devices) can be performed in the OR with standard instruments
  • Implant fixation with DePuy Synthes plates and screw systems
  • Short turnaround time.

PEEK MILLED IMPLANTS

PEEK MILLED IMPLANTS

PEEK MILLED IMPLANTS

PEEK MILLED IMPLANTS


Other Services Offered

  • One-to-one online design sessions for preoperative surgical planning
  • Online surgeon accounts
  • 3D tools for implant reviews
  • Supply of 3D data (format STL)

MATERIAL

PEEK (Polyetheretherketone)

  • Engineered for strength and stability
  • Radiolucent (minimal MRI artifact)
  • Bone-like stiffness and strength
  • Surgeon can determine plate and screw placement during surgery
  • Lightweight
  • Autoclavable

PEEK MILLED IMPLANTS

Notes regarding the use of PEEK Patient Specific Implants:

PEEK Patient Specific Implants require minimal (if any) modification. For minor fit modifications, it is suggested that the surgeon modify the patient bone rather than modifying the PEEK Patient Specific Implant. PEEK Patient Specific Implants can be modified with a high-speed burr, if needed. PEEK implants should be modified and rinsed in sterile saline solution away from the implant/surgical site to ensure that the particulate debris does not infiltrate the surgical site after any modifications.

DePuy Synthes standard plates and self-tapping or self-drilling screws should be used to attach the PEEK Patient Specific Implant to the patient.

Screw holes, regardless of screw size and type, must be predrilled away from the surgical site.

APPLICATIONS

DePuy Synthes PEEK Milled Implants (PSI) can be designed to fit voids in the cranial and craniofacial skeleton.

Depending on the size (length, width, and height) of the implant required, DePuy Synthes may design a single or multi-piece implant. Multi-piece implants allow the surgeon greater flexibility when treating larger defects. Multi-piece implants may be joined together using DePuy Synthes standard cranial and craniofacial fixation systems.

Onlays

1-piece onlay

1-piece onlay
 

2-piece onlay

2-piece onlay
 

2-piece onlay mandible

2-piece onlay mandible
 

1-piece

1-piece
 

2-piece

2-piece
 

3-piece

3-piece
 

1-piece

1-piece
 

2-piece

2-piece
 

1-piece

1-piece
 

1-piece

1-piece
 

2-piece

2-piece
 

3-piece

3-piece
 

 

WORKFLOW

  • Start by filling in a Request for Service (go to Download section) and upload the CT scan on PROPLAN CMF Online
  • We will design the implant according to your instructions and provide a quote; if required, an interactive design session can be done
  • Approve the implant when you are satisfied and place an order; your sales representative can help you with this
  • We will manufacture the implant and deliver it to you.
PEEK MILLED IMPLANTS

Supporting Documentation

Frequently Asked Questions (FAQ)

GETTING STARTED – PEEK MILLED IMPLANTS (ONLINE) REQUEST

I already have a PROPLAN CMF Online account, but I forgot my password. How can I access my account? 
Click on "Forgot your password?" in the PROPLAN CMF Online Sign In window. You have to enter the e-mail address you used to create your PROPLAN CMF Online account. You will then receive an e-mail with your password.

I have successfully logged-in to PROPLAN CMF Online. How can I create my first medical case?
Choose “Add Case” in your Home Screen. Follow the instructions on the screen and fill in the required fields in order to create your first case. Once the case is created, you can upload your CT Data and any other imaging files, and a filled-out Request for Service Form for your required procedure.

What if I forget what email address I signed up with?
Please contact us by email at [email protected]
or call +41 61 965 61 66

How do you provide the CT scan data?
The fastest method to make the CT data available to us is using PROPLAN CMF Online platform. Alternatively, you can ask your local DePuy Synthes representative for help or mail the CT scan data along with the filled-in Request for Quote (RFQ) form to:

Synthes GmbH
TRUMATCH CMF Team
Eimattstrasse 3
4436 Oberdorf
Switzerland 

Are there any specific requirements for CT Scan Data?
Yes, follow the Scan Protocol provided under the “Downloads” section in order to acquire CT Data that fulfills the requirements for PEEK Milled Implants.

I have successfully filled in and sent a Request for Quote form and uploaded the CT data. What follows?
You will be contacted by the clinical design team or by your local representative. In some cases, there will be a need to schedule a web meeting to discuss details of the case.
After all information is clear to the design team, your local representative will receive a document called "Order and Images for Approval", with the design and details of your case.

TIMELINES

How long does the process take?
From the validation of the CT scan data a minimum of 12 business days are required until the availability of the implant at the hospital. DePuy Synthes is committed to continuously improving the lead times of the patient specific devices, therefore please consult your local De Puy Synthes representative or send an enquiry by email at [email protected] for the latest information. 

My patient requires immediate surgery. Can you accommodate urgent requests?
We are able to accommodate few urgent requests on a special-request basis. Please contact your sales representative or call +41 61 965 61 66 to discuss your specific need.

How should I approve the "Order and Images for approval" document?
This document needs to be printed out, signed and send back via email at [email protected] or fax at the number +41 61 965 66 02, which is mentioned on the document.

COSTS

What are the costs for PEEK Milled Implants?
If a PEEK Milled Implant is to be purchased, the data preparation, the planning session and additional support to receive the product is included in the product price. For further information about the cost of the PEEK Milled Implant article you may contact your local DePuy Synthes representative.

When is a PEEK Milled Implant invoiced?
If the signed "Order and Images for approval" document has not been sent back, a case can be cancelled without any cost for the hospital. As soon as the signed document is sent back to the TRUMATCH CMF team, the implant will be invoiced.

What are the sterilization parameters for preparation for processing of the PEEK Milled Implants in the hospital?
Please refer to the product Instructions for Use (IFU).

Downloads

 

References

1  Jalbert F, Boetto S, Nadon F, Lauwers F, Schmidt E, Lopez R. One-step primary reconstruction for complex craniofacial resection with PEEK custom-made implants. J. Cranio-Maxillofacial Surg. 2014;42:141–148. 
2  Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016;27(8):2061-2072.
* Results from case studies are not predictive of results in other cases. Results in other cases may vary.

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