OsteoFlap®
System Overview
Product Training
- Raj Sarkar, PM
OsteoFlap®
Market Overview
Several methods are usually utilized to
achieve re-attachment of the cranial flap
after a craniotomy:
Plates and screws
Steel wire sutures
Clamping rachet designs
OsteoFlap®
Product Overview
Indications: OsteoFlap™ is indicated for
the re-attachment of the cranial flap after a
craniotomy.
Device Specification:
Made of titanium alloy (6Al-4V)
MRI compatible
Available in 11mm, 17mm and 22mm disk
diameters
Two tools available for disk removal
OsteoFlap®
Features & Benefits
Feature
Benefit
Titanium Alloy
Strength & Biocompatibility
Concave shape
Conforms to shape of cranial surface
Reduces soft tissue irritation
Strength due to formed shape
Recess formed to reduce potential
fixation rod protruding into soft tissue
Small, Fine threads
Infinite adjustability for adapting to flap
thickness
Narrow diameter chosen to allow for
intra-kerf placement
Threaded & welded into inferior plate for
additional strength
®
OsteoFlap
Features & Benefits
Outward radiating slots on
plate
Flanged for flexibility in adapting to cranium
interior
Flanges also can conform independently
and add rotation resistance of implant
Plate thickness, 0.83mm
Minimal invasion & protrudence into dura
3/4” Outer Diameter of Tool Large diameter for ease of use, minimal
effort required
Grooves on Outer
Diameter of Tool
Easy grip with gloved fingers
Instrument-free design
No instrumentation to be sterilized
OsteoFlap®
Surgical Technique
Implant Placement
After the surgical intervention, position the OsteoFlap Cranial
Flap Fixation Disks equally spaced on the dura. Position the
inferior disk so that the anti-rotation tab on the inferior disk
falls within the kerf width. Replace the bone flap, allowing it
to rest between the inferior and superior disks.
The superior disks are threaded down on each device with
the use of the attached driver tool. Tighten the superior disk
by pulling the rod in a superior direction with one hand, and
turning the driver tool with the other hand (Fig. A). DO NOT
secure any single device until all of the devices are loosely
tightened and the flap is correctly oriented. Final tightening
should be firm and represent the maximum force of the
fingers. Avoid capturing soft tissue or debris between the
disks and the bone.
NOTE: If the tab on the superior plate is not in the kerf width
when the device is secured, continue to turn the driver tool
until the tab is in the kerf width.
DRIVER TOOL
ANTI-ROTATION TAB
OsteoFlap®
Surgical Technique
Fig. B
Once all the implants have been secured, rock the disposable
driver tool in the direction of the arrows on the driver tool (Fig. B).
The center rod should break clean. Dispose of the driver tool and
broken center rod according to standard hospital procedure.
Repeat for all implants.
OsteoFlap®
Surgical Technique
Fig. C
Removal of Implant
Note: Removal Tool Kit is
required for removal.
Using the Tab Bending Tool
from the Removal Tool Kit ,
lift up on the anti rotation
tab until the tab clears the
kerf. Engage the removal
tool with the superior plate
and turn counter-clockwise
to remove superior disk.
OsteoFlap®
CLINICAL PHOTOGRAPHS
Ordering Information
Part Number
Description
219-0011
11mm Cranial Flap Fixation Device
219-0017
17mm Cranial Flap Fixation Device
219-0022
22mm Cranial Flap Fixation Device
219-0004
Cranial Flap Fixation Removal Kit
OsteoFlap®
Clinical Articles
Reliability of Cranial Flap Fixation Techniques:
Comparative Experimental Evaluation of Suturing,
Titanium Mini-plates, and a New Rivet-like Titanium
Clamp (CranioFix) Neurosurgery, Vol. 44, No. 4, April
1999
Bone Flap Fixation With Titanium Clamps: A New
Technique Surgical Neurology, Volume 53, Number 4,
April 2000
Cranial Bone Flap Fixation Clamps: Compatibility at MR
Imaging
Radiology, June 1998
OsteoFlap®
Competitive Product
Aesculap
CranioFix™ Titanium Clamp System
Advantages:
 First to market
 Sterile packaged
Disadvantages:
 Requires instrumentation
 Holding Forceps
 Applying Forceps
 Pin Cutter
 Removal Forceps
 4 steps to fixation
 Sterilizing, organizing, storing of instruments.
 Finite adjustability
Other Information:
 Available in 11mm, 16mm & 20mm
 Made of Titanium Alloy
 Biocompatible
 MR-compatible
OsteoFlap®
Competitive Product
Synthes
Flap-Fix™ Cranial Clamp
Advantages:
 Low profile reduces palpability
 Clover leaf design helps provide for
adaptation to the curvature of the
cranium.
Disadvantages:
 Requires instrument to cut implant
Other Information:
 Available in 13mm & 18mm
OsteoFlap®
Competitive Product
W. Lorenz
RapidFLAP™
Advantages:
 Sterile packaged
Disadvantages:
 Requires instrumentation
 Applier
 Post Cutter
 Post Holder
 Removal Forceps
 4 steps to fixation
 Sterilizing, organizing, storing of
instruments
Other Information:
 Available in 12mm, 16mm & 20mm
 Made of Titanium Alloy
Also available in Spin Down design
OsteoFlap®
Competitive Product
Leibinger
QuikDisk Cranial Fixation System
Advantages:
 Unique Grip-n-Zip application
 Packaged sterile
 Easy removal
Disadvantages:
 Requires instrumentation
 Sterilizing, organizing, storing of
instruments
Other information:
 Available in 14mm & 20mm
OsteoFlap®
FOR FURTHER PRODUCT RELATED QUESTIONS,
PLEASE CONTACT RAJ SARKAR ( Product ManagerNeuro) AT rsarkar@osteomedcorp.com or CALL
(972)677-4735.
For all sales related questions please
contact your regional sales support
representative.