← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K955837 # CANNULATED PLUS HIP SCREW (STERILE) (K955837) _Wrightmedicaltechnologyinc · HWC · Mar 4, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K955837 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Mar 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to: 1. femoral neck fractures; 2. arthrodesis of the hip; 3. femoral condyle fractures; 4. tibial plateau fractures; 5. ankle malleolar fractures; or 6. elbow fractures ## Device Story Cannulated bone screw; optional beveled washer for osteoporotic bone; available in various sizes. Used by orthopedic surgeons for internal fixation of cancellous bone fractures or arthrodesis. Device provides mechanical stabilization of bone fragments to facilitate healing. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Cannulated bone screw and optional washer; material: stainless steel; sterile. ## 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 - Cannulated PLUS™ Hip Screw ## 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} K955837 ![img-0.jpeg](img-0.jpeg) # WRIGHT ## MEDICAL TECHNOLOGY, INC. 5677 AIR INF ROAD ARLINGTON, IN 38002 901 877 9971 **510(k) SUMMARY** Contact Person: Judy English Date Prepared: December 22, 1995 Trade Name: Cannulated PLUS™ Hip Screw (Sterile) Common Name: Hip Bone Screw Classification: II Predicate Device: Cannulated PLUS™ Hip Screw This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. ## Description/Intended Use The Cannulated PLUS™ Hip Screw (Sterile) is a cannulated bone screw. An optional beveled washer is available for use with osteoporotic bone. The device is available in a range of sizes to fit varying anatomical requirements. The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to: 1. femoral neck fractures; 2. arthrodesis of the hip; 3. femoral condyle fractures; 4. tibial plateau fractures; 5. ankle malleolar fractures; or 6. elbow fractures ## Material The Cannulated PLUS™ Hip Screw (Sterile) is manufactured from stainless steel. The optional washer is also manufactured from stainless steel. 000040 71 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K955837](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K955837) **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