Who is the manufacturer of MITEK MICRO ANCHOR?

Mitek Products filed the 510(k) submission for MITEK MICRO ANCHOR (K962793).

What is the FDA product code for MITEK MICRO ANCHOR?

JDR. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for MITEK MICRO ANCHOR?

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

What are the predicate devices for MITEK MICRO ANCHOR?

Suture; Mitek GII Mini Anchor (K915089, K930892).

Who can help prepare an FDA 510(k) submission like MITEK MICRO ANCHOR?

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.

MITEK MICRO ANCHOR

K962793 · Mitek Products · JDR · Oct 1, 1996 · Orthopedic

Device Facts

Record ID	K962793
Device Name	MITEK MICRO ANCHOR
Applicant	Mitek Products
Product Code	JDR · Orthopedic
Decision Date	Oct 1, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
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 lateral canthoplasty and 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

Mitek Micro Anchor is a bone fixation device (3.7mm length, 1.3mm diameter) used to anchor USP #4/0 suture below the bone surface. Operated by surgeons in clinical settings to reattach injured soft tissue to bone. Device consists of titanium 6Al 4V body with Nitinol arc; delivered via drill bit and inserter. Provides secure fixation point for suture, facilitating tissue approximation during rehabilitation. Benefits include improved fixation strength compared to traditional suture-only methods.

Clinical Evidence

Safety and effectiveness established via clinical trials under IDE #G880026 and comparison to historical data for identical surgical procedures. Bench testing included pull tests in cadaveric (hand, skull) and porcine (metacarpal) models, showing average failure loads of 7.28–9.67 lbs, exceeding USP #4/0 suture (2.64 lbs).

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 lateral canthoplasty and collateral ligament repair around the proximal interphalangeal (PIP) joint in patients requiring soft tissue to bone reattachment.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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)

Related Devices

K982420 — MITEK MICRO ANCHOR · Mitek Products · Aug 24, 1998
K112237 — MICROSUTURE ANCHORS · Arthrex, Inc. · Sep 2, 2011
K180118 — Arthrex NanoSuture Anchor · Arthrex, Inc. · Feb 12, 2018
K991024 — BONE BULLET SUTURE ANCHOR · Linvatec Corp. · Nov 16, 1999
K962511 — MITEK MICRO ANCHOR · Mitek Products · Nov 6, 1996

Submission Summary (Full Text)

{0} K962793 OCT 1 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS ## MITEK MICRO ANCHOR ### SUBMITTER: NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive, Westwood, MA 02090 TEL#: 617-461-9700 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 lateral canthoplasty and 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. {1} 15962793 ## DESCRIPTION OF NON CLINICAL TESTS The MitekMicro Anchor pull tests from cadaveric and porcine locations produced an average failure load (LBS) of: 1) CADAVER HAND 9.67, SD 1.32 2) CADAVER SKULL 7.97, SD 1.92 3) PIG METACARPALS 7.28, SD 0.72 4) SUTURE W/ BONE TUNNELS 5.73, SD 0.46 USP Class I knot pull synthetic sterilized #4/0 suture, double strand, single knot, is 2.64 lbs. Suture tissue failure for 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.