← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K964945 # INNOVASIVE DEVICES ROTATOR CUFF FASTNER (K964945) _Innovasive Devices, Inc. · MBI · Feb 24, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964945 ## Device Facts - **Applicant:** Innovasive Devices, Inc. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Feb 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The 3.5mm ROC XS Suture Bone Fastener is intended for use in bladder neck suspension for female urinary incontinence due to urethral hypermobility. ## Device Story Implantable soft tissue fixation device; used for bladder neck suspension. System includes fastener and deployment instrumentation. Fastener consists of acetal plastic; deployed via polysulfone handle. Mechanism: crown component cams over stationary anvil, spreading device fingers to anchor in predrilled bone hole. Accompanied by stainless steel drill, drill guide, and awl. Used by surgeons in open or arthroscopic procedures. Provides secure suture fixation to bone; facilitates soft tissue repair. Benefits patient by stabilizing bladder neck to treat urinary incontinence. ## Clinical Evidence Bench testing only. Bone model testing compared ultimate holding strength and strength with #2 suture against the predicate device. Results confirmed the 3.5mm ROC XS Suture Bone Fastener holding strength is equivalent to the predicate. ## Technological Characteristics Materials: acetal plastic (fastener), polysulfone (deployment handle), stainless steel (drill, drill guide, awl). Mechanism: mechanical crown-to-anvil camming for finger expansion. Form factor: 3.5mm fastener. Sterilization: sterile, single-use fastener; reusable, autoclavable instrumentation. ## 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 - Innovasive 3.5mm ROC Suture Bone Fastener ([K964945](/device/K964945.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} K964945 510(k) SUMMARY FEB 24 1997 # 1. SUBMITTER: Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Contact: Eric Bannon, Vice President of Quality Assurance and Regulatory Affairs Date Prepared: December 4, 1996 # 2. DEVICE: Innovasive 3.5mm ROC XS Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices ROC Suture Bone Fastener # 3. PREDICATE DEVICE: The predicate device used to determine substantial equivalence for the Innovasive Devices 3.5mm ROC XS Suture Bone Fastener was the Innovasive 3.5mm ROC Suture Bone Fastener # 4. DEVICE DESCRIPTIONS: The Innovasive Rotator Cuff Fastener is an implantable soft tissue fixation device complete with the instrumentation needed to effect soft tissue to bone repair. The devices consist of a three component system comprised entirely of acetal plastic. The Fastener is deployed through the use of a deployment handle made of molded polysulfone. The Fastener is deployed into the bone by causing a crown component to cam over a stationary anvil causing the fingers of the device to spread. The Fastener comes with various non-absorbable suture material. In addition to the Fastener, a stainless steel drill, drill guide and awl are available to establish the proper hole for in the bone for the Fastener. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose. The Fastener will be available as a sterile, simple use device in both an open and arthroscopic version. Both sutured and sutured/less versions will be marketed. {1} # 5. INTENDED USE: The 3.5mm ROC XS Suture Bone Fastener is intended for use in bladder neck suspension for female urinary incontinence due to urethral hypermobility. # 6. COMPARISON OF CHARACTERISTICS: The Innovative Devices Rotator Cuff Fastener is comprised of acetal plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through the spreading of the fingers of a crown component resulting in an inverted umbrella design. The Innovative Devices ROC Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device. # 7. PERFORMANCE DATA: The following performance data was provided in support of the substantial equivalence determination: 1. Bone model testing: Comparison of the ultimate holding strength and the strength with #2 suture in a bone model compared to the predicate device. The Innovative 3.5mm ROC XS suture bone fastener holding strength was found to be equivalent to the strength of the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964945](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K964945) **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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