MITEK MICRO ANCHOR

K962511 · Mitek Products · MBI · Nov 6, 1996 · Orthopedic

Device Facts

• Record ID: K962511
• Device Name: MITEK MICRO ANCHOR
• Applicant: Mitek Products
• Product Code: MBI · Orthopedic
• Decision Date: Nov 6, 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 obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. 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

Bone fixation device; anchors USP #4/0 suture below bone surface. Components: 3.7mm x 1.3mm titanium anchor with Nitinol arc; delivery system includes drill bit and inserter. Used by surgeons in clinical settings to reattach injured soft tissue to bone. Provides mechanical fixation for collateral ligaments of PIP joint; facilitates tissue approximation during rehabilitation. Offers greater strength than suture alone.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dimensions: 3.7mm length, 1.3mm diameter. Materials: Titanium 6Al 4V, Nitinol arc. Delivery system: drill bit and inserter. Mechanical fixation principle.

Indications for Use

Indicated for anchoring suture into bone to reattach soft tissue to bone, specifically for collateral ligament(s) around the proximal interphalangeal (PIP) joint.

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

• SUTURE
• Mitek GII Mini Anchor (K915089, K930892)

Submission Summary (Full Text)

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NOV - 6 1996
K962511

SUMMARY OF SAFETY AND EFFECTIVENESS
MITEK MICRO ANCHOR

SUBMITTER:
NAME: Mitek Surgical Products, Inc.
ADDRESS: 60 Glacier Drive, Westwood, MA 02090
TELEPHONE: [phone]
CONTACT: Edward F. Kent, Vice President, Regulatory Affairs
DATE: June 28, 1996

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

PREDICATE DEVICE: SUTURE

DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #4/0 suture below bone surface.

DEVICE DESIGN
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal Anchors. The Mitek Mini Anchor design was first cleared to market by US FDA in K915089 and K930892.

MATERIAL USED
The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, 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 obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. 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 #4/0 suture, and is the same "design" as the Mitek Mini Anchor.