← Product Code [MIB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MIB) · K982688 # SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (K982688) _Spectrum Designs, Inc. · MIB · Oct 13, 1998 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K982688 ## Device Facts - **Applicant:** Spectrum Designs, Inc. - **Product Code:** [MIB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MIB.md) - **Decision Date:** Oct 13, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3620 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use The Spectrum Designs Pre-Form Contour Carving Block is a pre-formed solid silicone block to be used where a shaped, cut-to-fit implant is desired. The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation. ## Device Story The Spectrum Designs Pre-Form Contour Silicone Carving Block is a solid silicone elastomer implant with a pre-formed, rounded shape. It is intended for use by surgeons in clinical settings to augment or reconstruct cartilaginous, soft, or bone tissue. The surgeon manually cuts and shapes the block to fit the specific anatomical requirements of the surgical site. By providing a pre-shaped starting point, the device offers increased flexibility for customization during the procedure. The implant is intended to provide structural support or volume restoration in reconstructive or aesthetic surgical applications. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Fabricated from solid silicone elastomer. Pre-formed, rounded geometry. Designed for manual intraoperative carving and customization. Non-active, mechanical implant. ## 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 - Spectrum Designs Silicone Block Implant - Spectrum Designs Pectoral Implant - Silimed Elastomer, Silicone Block - SILIMED Calf Implant ## Related Devices - [K974480](/device/K974480.md) — SILIMED CALF IMPLANT · Silimed, LLC · Feb 24, 1998 - [K981851](/device/K981851.md) — SILIMED SILICONE CARVING BLOCK · Silimed, LLC · Jul 9, 1998 - [K021820](/device/K021820.md) — AART SILICONE CARVING BLOCK · Aesthetic and Reconstructive Technologies, Inc. · Jul 16, 2002 - [K974654](/device/K974654.md) — SILICONE BLOCKS · Specialty Surgical Products, Inc. · Feb 24, 1998 - [K974482](/device/K974482.md) — SILIMED GLUTEAL IMPLANT · Silimed, LLC · Feb 24, 1998 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '982688'. The numbers are written in a cursive style, with some of the digits connected to each other. The image has a clear and legible quality, making the characters easily distinguishable. OCT 13 1998 ## SUMMARY OF SAFETY AND EFFECTIVENESS # SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK IMPLANT ## 510K SUMMARY #### 1. Submitter's Data Spectrum Designs Inc. 6387 B. Rose Lane Carpinteria, CA 93117 Contact Person: Jim Dishman (805) 684 -7678 Telephone: Date Prepared: July 22, 1998 ## 2. Device Name, Classification Name: Spectrum Designs Pre-Form Contour Silicone Carving Block FDA Classification: Class II FDA Code: MIB ## 3. Identification of Substantially Equivalent Devices Spectrum Designs Silicone Block Implant Spectrum Designs Pectoral Implant Silimed Elastomer, Silicone Block , SILIMED Calf Implant #### 4. Device Description The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape. #### 5. Indications for Use The Spectrum Designs Pre-Form Contour Carving Block is a pre-formed solid silicone block to be used where a shaped, cut-to-fit implant is desired. ## 6. Contraindications for Use Contraindications for routine aesthetic surgery include the presence of infection anywhere in the body and in particular, in the region in which the device will be implanted. ## 7. Warnings, Precautions Possible complications include: - Displacement of the implant may occur, especially from dissection of too large a pocket. . - . Errors in positioning the implant may result in patient dissatisfaction - Tissue necrosis may result in extrusion of the implant. This can occur as a result of such factors . as the pocket created being too small, use of too large an implant, or when soft tissues are inadequate to maintain coverage over the prosthesis - Resorption of the underlying bone may occur with use of the implant. . - . Fibrous tissue encapsulation can occur around any implant, with subsequent increased firmness, possible displacement, and/or pains. - Complications from this or any similar surgery may include infection, neural damage, hematoma, . poor would healing, patient intolerance to foreign body implantation, and other similar complications. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 13 1998 Mr. Jim Dishman President Spectrum Designs, Inc. 6387 B Rose Lane Carpinteria, California 93013 Re: K982688 Trade Name: Spectrum Designs Pre-Form Contour Silicone Carving Block Regulatory Class: Unclassified Product Code: мів Dated: July 22, 1998 Received: August 03, 1998 Dear Mr. Dishman: We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Mr. Jim Dishman This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html". Sincerely yours, C. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE Applicant: Spectrum Designs Inc. 510(k) Number : K982688 Device Name: Spectrum Designs Pre-Form Contour Silicone Carving Block Indications for Use: The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH Office of Device Evaluation (ODE) | | |-------------------------------------------------------|-----------------------------------------| | | (Division Sign-Off) | | | Division of General Restorative Devices | | 510(k) Number | 12982688 | | Prescription use<br>Per 21 CFR 801.109 | or Over the counter | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K982688](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K982688) **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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