← Product Code [KHJ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHJ) · K970910 # XOMED SILICONE BLOCK/STRIP (K970910) _Xomed, Inc. · KHJ · May 2, 1997 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHJ/K970910 ## Device Facts - **Applicant:** Xomed, Inc. - **Product Code:** [KHJ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHJ.md) - **Decision Date:** May 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3620 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Indications for Use The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery. ## Device Story Sterile silicone elastomer implants; molded into square or rectangular shapes of varying sizes, thicknesses, and durometers. Used in otorhinolaryngological and head/neck reconstructive surgeries as space-occupying augmentation or surgical repair aids. Implanted by surgeons during procedures. Provides structural support or volume replacement in surgical sites. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence based on material composition and historical clinical use of silicone elastomers in ENT surgery. ## Technological Characteristics Material: Silicone elastomer. Form factor: Molded blocks and strips of varying dimensions and durometers. Sterilization: Sterile. ## Regulatory Identification Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene. ## Predicate Devices - Xomed Silicone Sheeting ([K953013](/device/K953013.md)) - Implantech Silicone Block ([K913882](/device/K913882.md)) - Dow Silicone Block - McGhan Silicone Block ## 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} MAY - 2 1997 XOMED SURGICAL PRODUCTS K970910 # 510(k) Summary 1.0 Date Prepared March 6, 1997 2.0 Submitter (Contact) David Timlin Xomed Surgical Products Jacksonville, FL (904) 279-7532 3.0 Device Name Proprietary Name: Xomed Silicone Block/Strip Common Name(s): Silicone Block/Strip Classification Name: ENT synthetic polymer material 4.0 Device Classification ENT: Procode 77 Class II: 21 CFR 874.3620 Tier 3 General and Restorative: Unclassified 5.0 Device Description Xomed Silicone Block/Strip are sterile, implants produced from silicone elastomer molded into a squares and/or rectangular shapes of various sizes and thicknesses and durometer as specified on each product label. 6.0 Intended Use The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery. 7.0 Substantial Equivalence Both silicone sheeting and silicone block were marketed by Xomed prior to May 16, 1976. A reinforced version of the Silicone Sheeting was introduced in 1995 via 510(k) [K953013]. The Silicone Block and Strip proposed in this submission are substantially equivalent to these predicate products in that they have the same intended use and are made from essentially the same base material. Additionally, the proposed devices are similar to predicate products from other manufacturers, i.e. Implantech Silicone Block (K913882), Dow Silicone Block and McGhan Silicone Block (510k unknown). Again, the intended use and base materials are essentially identical. 6743 Southpoint Dr. N., Jacksonville, Florida 32216-0980 • 904-296-9600 Customer Service 1-800-874-5797 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHJ/K970910](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/KHJ/K970910) **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