← Product Code [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK) · K965056 # OSTEONICS SCREW HOLE PLUGS (K965056) _Osteonics Corp. · JDK · Feb 28, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K965056 ## Device Facts - **Applicant:** Osteonics Corp. - **Product Code:** [JDK](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JDK.md) - **Decision Date:** Feb 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.3300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to acetabular shell components-- would be subject to all of the indications and contraindications of the associated acetabular shells. ## Device Story Small circular plugs; manufactured from low density polyethylene; designed to occlude unused acetabular dome screw holes in Osteonics acetabular shell components. Factory-assembled to shell; surgeon removes plugs intraoperatively from holes requiring bone screws. Function: prevent bone cement intrusion into shell and debris migration into acetabulum. Used in OR by orthopedic surgeons during hip arthroplasty. Non-load bearing; no contact with acetabular insert or host bone. ## Clinical Evidence Bench testing only. Laboratory testing performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading. ## Technological Characteristics Material: low density polyethylene. Form factor: small circular disks. Function: non-load bearing mechanical occlusion of acetabular screw holes. Pre-assembled to acetabular shell components. ## Regulatory Identification Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. ## Predicate Devices - Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System - Osteonics® Acetabular Screw Hole Plugs - Osteonics® Universal Cement Plug ## 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} FEB 28 1997 K965056 510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Screw Hole Plugs ## Submission Information | Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 | | --- | --- | | Contact Person: | Terry Sheridan Regulatory Affairs Specialist | | Date of Summary Preparation: | December 17, 1996 | ## Device Identification | Proprietary Name: | Osteonics® Screw Hole Plugs | | --- | --- | | Common Name: | Prosthesis, hip, cement restrictor | | Classification Name and Reference: | Surgical mesh 21 CFR §878.3300 | ## Predicate Device Identification The Osteonics® Screw Hole Plugs are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA: - Osteonics® Omnifit® UHMWPE Acetabular Shell Cement Spacer System, - Osteonics® Acetabular Screw Hole Plugs, - Osteonics® Universal Cement Plug ## Device Description The Osteonics® Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene and which are intended to occlude all acetabular dome screw holes not occupied by bone screws. The Osteonics® Screw Hole Plugs will be factory-assembled to every Page 1 {1} acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum. ## Intended Use: The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-- as accessories to acetabular shell components-- would be subject to all of the indications and contraindications of the associated acetabular shells. ## Statement of Technological Comparison: The substantial equivalence of the subject devices to the predicate devices, in terms of design, materials, and intended use are discussed below. ## Design: The subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are both circular disks intended to occlude unused screw holes. The subject devices are pre-assembled to their shells at Osteonics, and may be removed by the surgeon intraoperatively. The predicate devices were not pre-assembled, but instead were assembled to their shells intraoperatively. ## Materials The subject devices are made from low density polyethylene. The predicate cement plug is made from the same low density polyethylene as the subject device. The subject devices have been designed so that they contact neither the acetabular insert nor the acetabular host bone. Because the subject devices are non-load bearing, low density polyethylene is an appropriate material for this application. ## Intended Use: Both the subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are intended to occlude unused screw holes, thus preventing potential intrusion of bone cement and potential emigration of debris through the shell screw holes into the acetabulum. Both the subject and predicate devices are intended for cemented or cementless applications, depending upon the intended use of the associated acetabular shell. ## Performance Data: Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading. Page 2 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K965056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDK/K965056) **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