← Product Code [KGS](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS) · K030031 # SOFT TISSUE ANCHORING WASHERS (K030031) _Accu-Speed, Incorporated · KGS · Jan 28, 2003 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K030031 ## Device Facts - **Applicant:** Accu-Speed, Incorporated - **Product Code:** [KGS](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS.md) - **Decision Date:** Jan 28, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4930 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] are to be used for anchoring soft tissue to bone. ## Device Story Soft Tissue Anchoring Washers are surgical implants designed to anchor soft tissue to bone. Used by surgeons in clinical settings to provide mechanical fixation during orthopedic or reconstructive procedures. Device functions as a physical interface between suture/fastener and bone surface to prevent tissue pull-through or hardware migration. Benefits include enhanced stability of soft tissue repair. No electronic, software, or algorithmic components. ## Clinical Evidence Bench testing only. ## Technological Characteristics Mechanical suture retention device (washer/bolt/nut configuration). Materials and dimensions consistent with standard orthopedic fixation hardware. No energy source, connectivity, or software. ## Regulatory Identification A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Accu-Speed, Inc. Robert W. Secovich President P. O. Box 1008 65 Gay Road Groton, Massachusetts 01450 JAN 2 8 2003 Re: K030031 Trade/Device Name: Soft Tissue Anchoring Washers Regulation Number: 878.4930 Regulation Name: Suture retention device Regulatory Class: Class II Product Code: KGS; MBI Dated: December 24, 2002 Received: January 3, 2003 Dear Mr. Secovich: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally {1}------------------------------------------------ Page 2 - Mr. Robert W. Secovich 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Sincerely yours, Mark A Millman Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## VII. INDICATIONS FOR USE STATEMENT 510(k:) Number: Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Device Name: The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone. Mark A. Wilkerson Jivision Sign-Off) Division of General, Restorative and Neurological Devices Number K03003/ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K030031](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGS/K030031) **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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