Who is the manufacturer of TITANIUM TUBE TO TUBE CLAMP?

Synthes (Usa) filed the 510(k) submission for TITANIUM TUBE TO TUBE CLAMP (K960782).

What is the FDA product code for TITANIUM TUBE TO TUBE CLAMP?

JEC. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for TITANIUM TUBE TO TUBE CLAMP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TITANIUM TUBE TO TUBE CLAMP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Related Devices

K962484 — SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) · Synthes (Usa) · Sep 5, 1996
K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM · Orthopaedic Innovations, Inc. · Mar 18, 1996
K030390 — SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE · Synthes (Usa) · Apr 1, 2003
K961618 — MONOTUBE TUBE TO RING CLAMP · Howmedica Corp. · May 28, 1996
K954053 — BERLIN EXTERNAL FIXATOR · Encore Orthopedics, Inc. · May 16, 1996

Submission Summary (Full Text)

{0} 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 | (610) 647-9700 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.