Rapid Resorbable Cranial Clamp - Synthes

RAPID Resorbable Cranial Clamp

Rapid Resorbable Cranial Clamp

For cranial bone flap fixation

Indications

The Synthes Rapid Resorbable Cranial Clamps are
intended for covering burr holes and for fixation of
cranial bone flaps, in pediatric and adult patients.

Contraindications

The Synthes Rapid Resorbable Cranial Clamps are
not intended for use in the presence of:
• Active or latent infection
• Limited blood supply
• Insufficient quantity or

quality of bone

Features Material

• Facilitates rapid fixation (and removal, if necessary) • Manufactured from 85:15 poly(L-lactide-
of a cranial bone flap co-glycolide), the same substantially
amorphous copolymer used in other
• Only one instrument required to tighten and cut clamps Synthes Rapid Resorbable Fixation
System implants
• Appropriate fixation for bone healing of approximately
8 weeks postoperatively • Resorption time of approximately
12 months allows the vascular system
• Resorption time of approximately 12 months to remove material gradually

• Eliminates the need to drill or tap for screw fixation • Proven biocompatible material1

• 18 mm diameter 1. Based on biocompatibility testing per ISO10993-1:2003(E)
conducted by Synthes (USA).
• Flexible disk design produces compressive force to
firmly secure flap

• Ratcheting feature allows preliminary placement
of top disk until final fixation is achieved

• Resorbable material eliminates the need for a second
procedure for implant removal

• Radiolucent in X-ray, MRI, and CT scan procedures

Instruments and implants
approved by the AO Foundation

RAPID Resorbable Cranial Clamp
Surgical Technique

1 Place clamps 2 Replace the cranial bone flap

With the cranial bone flap removed, position the Replace the bone flap, ensuring the shafts of the
cranial clamps equidistant around the opening. Place cranial clamps remain vertical in the kerf.
the bottom disks between the dura and the skull.
Pretension each clamp by pressing the top disk
Note: A minimum of three cranial clamps is required to the cranial surface. A two-finger pinching
for secure fixation of cranial bone flaps in pediatric technique is suggested.
patients. Depending on the patient, e.g. adult, and
bone-flap size, more fixation points may be required. When using more than three clamps, tighten the
clamps in a crisscross pattern.

3 Engage application device 4 Apply tension

Flip the ratcheting mechanism forward to engage. Squeeze the instrument handles to tension the
Place the application device over a clamp shaft cranial clamp.
and lower the instrument to the top disk.
Note: If clamps were not pretensioned as described
in step 2, the tensioning step may be repeated to
fully fixate the clamp.

Ratcheting
mechanism

Application Device for Resorbable
Cranial Clamps
[329.317]

Cutting trigger

5 Cut the stem Removal
To re-enter the cranium postoperatively, use
While maintaining tension on the clamp, cut the stem forceps to grasp the top disk of the clamp along
by squeezing the cutting trigger. After cutting a stem, the kerf. Release the disk by lifting and rotating
release the ratcheting mechanism on the instrument. it parallel to the kerf.
Repeat steps 3–5 until all clamps have been secured.
Repeat this procedure with the remaining
Notes: clamps. The bone flap can now be removed.
• The Rapid Resorbable Cranial Clamps are single-use
• The clamps are not recommended for kerf
only and must be discarded after removal. Use new widths less than 1.5 mm or greater than
clamps to reattach the cranial bone flap. 4 mm. Clamps are not recommended for burr
• The kerf must be perpendicular to the surface of the holes larger than 10 mm in diameter.
cranium for proper placement of the clamps.

RAPID Resorbable Cranial Clamp

Product Information

Implants

851.801.01S Rapid Resorbable Cranial Clamp, 18 mm, sterile, 1/pkg

Instrument

329.317 Application Device, for Resorbable Cranial Clamp

Instrument Tray

305.880 Resorbable Cranial Clamp Instrument Tray Assembly

305.880 consists of:

305.881 Lid

304.686 Instrument Tray

305.882 Insert

Synthes CMF Synthes (Canada) Ltd. www.synthes.com
1302 Wrights Lane East 2566 Meadowpine Boulevard
West Chester, PA 19380 Mississauga, Ontario L5N 6P9
Telephone: (610) 719-5000 Telephone: (905) 567-0440
To order: (800) 523-0322 To order: (800) 668-1119
Fax: (610) 251-9056 Fax: (905) 567-3185

© 2004 Synthes, Inc. or its affiliates. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/07 J5393-E