TITANIUM TUBE TO TUBE CLAMP

K960782 · Synthes (Usa) · JEC · May 8, 1996 · Orthopedic

Device Facts

• Record ID: K960782
• Device Name: TITANIUM TUBE TO TUBE CLAMP
• Applicant: Synthes (Usa)
• Product Code: JEC · Orthopedic
• Decision Date: May 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes.

Device Story

Titanium alloy clamp; connects carbon fiber rods or stainless steel tubes; used in external fixation frames for long bone fracture treatment; operated by surgeons in clinical/OR settings; provides mechanical stability to fracture site; facilitates bone healing via rigid fixation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy construction; mechanical clamping mechanism; designed for carbon fiber rods or stainless steel tubes.

Indications for Use

Indicated for patients with long bone fractures requiring external fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Ace Medical’s Articulation Coupler

Submission Summary (Full Text)

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SYNTHES
MAY - 8 1996
K960782

**Attachment VII:** Summary of Safety and Effectiveness Information [510(k) Summary]

| Synthes (USA)
1690 Russell Road
P.O. Box 1766
Paoli, PA 19301 | [phone]
Contact: Angela J. Silvestri
February 22, 1996 |
| --- | --- |

Synthes Ti Tube to Tube Clamp is compared to Ace Medical’s Articulation Coupler.

Synthes Ti Tube to Tube Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.

Ace Medical’s Articulation Coupler is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the two rods. The clamps attach the two carbon fiber rods or stainless steel tubes. The device is manufactured from a Titanium Alloy.

Based on mechanical test results, the Ti Tube to Tube Clamp has been found to be substantially equivalent to the Articulation Coupler.