← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K962511 # MITEK MICRO ANCHOR (K962511) _Mitek Products · MBI · Nov 6, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962511 ## Device Facts - **Applicant:** Mitek Products - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Nov 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K915089.md), [K930892](/device/K930892.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 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 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962511](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K962511) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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