← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K955306 # OMEGA+ COMPRESSION SCREW SYSTEM (K955306) _Howmedica Corp. · KTT · Apr 10, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K955306 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Apr 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). ## Device Story Metallic bone fixation system; includes lag screws, proximal hip sideplates, supracondylar side plates, and compression screw. Used for temporary stabilization of proximal and distal femoral fractures. Components previously cleared; current submission introduces sterile packaging option. Intended for use by orthopedic surgeons in clinical/surgical settings. No changes to design, materials, manufacturing, or surgical technique. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence established via comparison to previously cleared predicate devices. ## Technological Characteristics Metallic bone fixation appliances; components include lag screws, sideplates, and compression screws. No changes to materials or design from predicate devices. Sterilization provided via validated technique for sterile packaging option. ## 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 - [K850886](/device/K850886.md) - [K872223](/device/K872223.md) - [K922295](/device/K922295.md) - [K930156](/device/K930156.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} K955306 510(k) Summary of Safety and Effectiveness Proprietary Name: Omega+ Compression Screw System Common Name: Compression Screw System Classification Name and Reference: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories Proposed Regulatory Class: Class II Device Product Code: KTT OR(87) For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica 359 Veterans Boulevard Rutherford, New Jersey 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870 Date Summary Prepared: 11-9-95 The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile. Directions for one recommended sterilization technique are included in the labeling for the device. There is no change in intended use, design, material, method of manufacture, or surgical technique for the device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K955306](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K955306) **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