← Product Code [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR) · K965175 # HOWMEDICA MAINSTAY ANCHOR (K965175) _Howmedica Corp. · JDR · Mar 13, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K965175 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR.md) - **Decision Date:** Mar 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K953531.md)) ## Reference Devices - Mitek SuperAnchor ## 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} K965175 510(k) Summary MAR 13 1997 Device: Howmedica Mainstay™ Soft Tissue Anchor 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. The 510(k) for this device K953531 was determined to be substantially equivalent on September 26, 1995. This present submission is being made to introduce an additional indication for use in soft tissue reconstruction following total hip arthroplasty. Testing was performed in accordance with that described in the FDA "Bone Anchor Devices: Guidance for Testing - April 20, 1996." Results of this testing indicated that the initial fixation strength of the Mainstay™ Soft Tissue Anchor did not differ significantly from that of the Mitek SuperAnchor when used in the same anatomic site. For information contact: John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K965175](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K965175) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com