Who is the manufacturer of MONOTUBE TUBE TO RING CLAMP?

Howmedica Corp. filed the 510(k) submission for MONOTUBE TUBE TO RING CLAMP (K961618).

What is the FDA product code for MONOTUBE TUBE TO RING 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 MONOTUBE TUBE TO RING CLAMP?

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

What are the predicate devices for MONOTUBE TUBE TO RING CLAMP?

Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling); Synthes Ring-to-Rod Clamp; Zimmer Torus Ring-to-Rod Clamp.

Who can help prepare an FDA 510(k) submission like MONOTUBE TUBE TO RING 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.

MONOTUBE TUBE TO RING CLAMP

K961618 · Howmedica Corp. · JEC · May 28, 1996 · Orthopedic

Device Facts

Record ID	K961618
Device Name	MONOTUBE TUBE TO RING CLAMP
Applicant	Howmedica Corp.
Product Code	JEC · Orthopedic
Decision Date	May 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

This device is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Device Story

External fixation clamp; connects Monticelli/Spinelli circular frame rings to Monotube external fixation system tubes. Enables angulation between circular frame and tube components. Used in orthopedic surgery for fracture stabilization. Physician-operated in clinical/OR settings. Provides hybrid construct combining pin fixation with ring/wire fixation.

Clinical Evidence

Bench testing only. Performance comparison of Monotube Hybrid Frame versus Monticelli/Spinelli Hybrid Frame using Hoffmann External Fixation System components.

Technological Characteristics

Materials: Stainless steel and aluminum. Function: Mechanical fixation clamp for external frame systems. Design: Articulating coupling for angulation between circular rings and fixation tubes.

Indications for Use

Indicated for patients with open and/or unstable fractures where soft tissue injury precludes alternative treatments like IM rodding or casting.

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

Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling)
Synthes Ring-to-Rod Clamp
Zimmer Torus Ring-to-Rod Clamp

Reference Devices

Monotube External Fixation System
Monticelli/Spinelli Circular External Fixation System
Hoffmann External Fixation System

Related Devices

K960782 — TITANIUM TUBE TO TUBE CLAMP · Synthes (Usa) · May 8, 1996
K011948 — HOFFMAN II HYBRID RING CLAMP · Howmedica Osteonics Corp. · Jul 13, 2001
K960269 — TITANIUM UNIVERSAL CLAMP · Synthes (Usa) · Apr 4, 1996
K111376 — CONSTRUX EXTERNAL FIXATION DEVICE · Ebi, LLC · Aug 3, 2011
K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM · Orthopaedic Innovations, Inc. · Mar 18, 1996

Submission Summary (Full Text)

{0} MAY 28 1996 K961618 510(k) Summary Prepared: April 19, 1996 Trade Name: Monotube® Tube to Ring Clamp Common Name: External Fixation Clamp Classification Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER 888.3040 This submission describes an external fixation clamp to used to provide a hybrid construct combining the pin fixation of the Monotube® External Fixation System with the Ring and wire fixation of the Monticelli/Spinelli Circular External Fixation System. This device is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. The Monotube® Tube to Ring Clamp is designed to connect the Ring of a Monticelli/Spinelli Circular Frame to a Monotube® Tube. The Clamp provides for angulation between the circular frame and the tube of the external frame system. The Clamp is manufactured from Stainless Steel and Aluminum. Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Howmedica Monticelli/Spinelli Sliding Clamp (with Articulating Coupling), the Synthes Ring-to-Rod Clamp and the Zimmer Torus Ring-to-Rod Clamp. Testing of this device is presented within the submission. Testing was preformed to compare the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame using components of the Hoffmann External Fixation System. For information contact: John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870