HOWMEDICA MAINSTAY ANCHOR
Device Facts
| Record ID | K965175 |
|---|---|
| Device Name | HOWMEDICA MAINSTAY ANCHOR |
| Applicant | Howmedica Corp. |
| Product Code | JDR · Orthopedic |
| Decision Date | Mar 13, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Howmedica Mainstay™ Soft Tissue Anchor is a titanium alloy self-drilling, self-tapping cancellous screw threaded device for the attachment of soft tissue to bone. The device is available in three sizes and has a proximal thru-hole for the attachment of the desired suture material. The purpose of the device is to hold, with sutures, the soft tissue against the bone for a prescribed healing period. This device is to be used for soft tissue attachment in the shoulder, ankle, foot, wrist, hand, elbow, knee and pelvis.
Device Story
Titanium alloy self-drilling, self-tapping cancellous screw; proximal thru-hole for suture attachment; used by surgeons to secure soft tissue to bone in various orthopedic sites; holds tissue against bone during healing; provides initial fixation strength.
Clinical Evidence
Bench testing only; performed per FDA 'Bone Anchor Devices: Guidance for Testing - April 20, 1996'. Results show initial fixation strength not significantly different from Mitek SuperAnchor.
Technological Characteristics
Titanium alloy; self-drilling, self-tapping cancellous screw design; three sizes; proximal thru-hole for suture.
Indications for Use
Indicated for soft tissue attachment to bone in shoulder, ankle, foot, wrist, hand, elbow, knee, and pelvis, including soft tissue reconstruction following total hip arthroplasty.
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
- Howmedica Mainstay™ Soft Tissue Anchor (K953531)
Reference Devices
- Mitek SuperAnchor
Related Devices
- K040331 — SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS · Smith & Nephew, Inc. · Apr 14, 2004
- K213104 — Auxilock Titanium Screw-In Suture Anchor · Auxein Medical Private Limited · Jul 29, 2022
- K013534 — SELF-COUNTERSINKING BONE SCREW · Biomet Orthopedics, Inc. · Dec 17, 2001
- K042460 — TI - SCREW ANCHOR SP · Arthrotek, Inc. · Oct 29, 2004
- K012503 — METAL SCREW ANCHOR · Biomet Manufacturing, Inc. · Oct 22, 2001
