MITEK THREADED ANCHOR (MODIFICATION)

K961094 · Mitek Products · MBI · Oct 3, 1996 · Orthopedic

Device Facts

• Record ID: K961094
• Device Name: MITEK THREADED ANCHOR (MODIFICATION)
• Applicant: Mitek Products
• Product Code: MBI · Orthopedic
• Decision Date: Oct 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used to anchor suture into bone. The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to expand the indications to include the browlift procedure. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

Device Story

Threaded bone anchor; 2.0mm diameter; 3.6mm length; Titanium 6Al 4V construction. Used by surgeons to anchor USP #2/0 suture into bone for soft tissue reattachment. Delivery system includes anchor tab, drill bit, and inserter. Operates by mechanical fixation below bone surface. Provides higher pull-out strength than suture alone; facilitates tissue approximation during healing. Used in clinical settings for orthopedic or reconstructive procedures.

Clinical Evidence

Safety and effectiveness supported by clinical trials under IDE #G880026 and comparison to historical data for identical surgical procedures. Bench testing: pull tests from cadaveric locations (N=30) yielded average failure load of 32.7 lbs (SD 1.9).

Technological Characteristics

Material: Titanium 6Al 4V. Dimensions: 2.0mm diameter, 3.6mm length. Design: Threaded anchor. Delivery system: Anchor tab, drill bit, inserter. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring soft tissue to bone reattachment, including browlift procedures, during rehabilitation.

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

• Mitek Threaded Anchor (K945203)

Reference Devices

• Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al, The American Journal of Sports Medicine, Vol. 14, No. 5, 1986

Submission Summary (Full Text)

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K961094
Oct. 3, 1996

SUMMARY OF SAFETY AND EFFECTIVENESS
MITEK THREADED 2.0mm ANCHOR

SUBMITTER:
NAME: Mitek Surgical Products, Inc.
ADDRESS: 60 Glacier Drive, Westwood, MA 02090
TEL#: [phone]
CONTACT: Edward F. Kent, Vice President, Regulatory Affairs
DATE: March 12, 1996

NAME OF DEVICE
CLASSIFICATION NAME: Staple, Fixation, Bone
COMMON NAME: Appliance for reconstruction of bone to soft tissue
PROPRIETARY NAME: MITEK THREADED ANCHOR

PREDICATE DEVICE: MITEK THREADED ANCHOR

DESCRIPTION OF DEVICE

FUNCTION
Fixation of USP #2/0 suture below bone surface.

DEVICE DESIGN
The Mitek Threaded Anchor is a threaded design, 2.0 mm in diameter and 3.6 mm in length. It is manufactured from Titanium 6Al 4V. It is similar in design to the 3.0mm, 4.0mm and the 5.2mm Mitek Threaded Anchor. These designs were cleared to market in K945203.

MATERIALS USED
The Mitek Threaded Anchor delivery system consists of a Mitek Threaded Anchor Tab, a drill bit, and an Inserter.

INTENDED USE
The device is used to anchor suture into bone. The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to expand the indications to include the browlift procedure. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.

COMPARISON TO PREDICATE DEVICE
It has greater strength than USP #2/0 suture, and is the same design as the Mitek 3.0mm, 4.0mm and 5.2mm Mitek Threaded Anchors.

DESCRIPTION OF NON CLINICAL TESTS
The Mitek Threaded Anchor pull tests from cadaveric locations produced an average failure load of 32.7 lbs, SD 1.9, N=30.

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USP knot pull synthetic sterilized suture, double strand, is 6.34 lbs.

Suture tissue failure tendinous tissue is 15.75 lbs, and capsular tissue is 21.80 lbs. Reference: Soft Tissue Fixation to Bone, Daniel B. Robertson, M.D. et al, The American Journal of Sports Medicine, Vol. 14, No. 5, 1986.

## DESCRIPTION OF CLINICAL TESTS

The clinical tests were done in accordance with IDE #G880026. Safety and effectiveness was based upon the results obtained in the clinical trials and their equivalence to historical data for the identical surgical procedure.

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