← Product Code [MBI](/productcode/MBI) · K013553 # PRE-LOADED ULTRAFIX RC (K013553) _Linvatec Corp. · MBI · Dec 19, 2001 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K013553 ## Device Facts - **Applicant:** Linvatec Corp. - **Product Code:** [MBI](/productcode/MBI.md) - **Decision Date:** Dec 19, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the site of either arthroscopically or in an open technique. ## Device Story Pre-Loaded UltraFix® RC is a sterile, single-use suture anchor system; consists of a suture anchor preloaded with USP#2 non-absorbable polyester suture onto a disposable inserter; used by surgeons in clinical settings for rotator cuff repair; device facilitates tissue fixation to bone; provides mechanical stability during healing; intended for both arthroscopic and open surgical procedures. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: 316(L) stainless steel per ASTM F138-92/ISO 5832-1. Components: Suture anchor, USP#2 non-absorbable polyester suture, disposable inserter. Sterilization: Sterile. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - UltraFix® RC Linvatec ([K963812](/device/K963812.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}------------------------------------------------ # DEC 1 9 2001 October 23, 2001 # SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the requirements of the Safe Medical Device Act of In accordance with the requirements of the Sale Medical Donatting the Market Corporation of the Market Corporation of the Pre-Loaded UltraFix in 20 1990 and 21 CFR 807.92, Linvatec Corporation is nereoy addining of the Pre-Loaded UltraFix® 510(k) Summary of Safety and Effectiveness for the Pre-Loaded UltraFix® RC. RC. 510(k) Number _K013553. #### Submitter A. Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 #### Company Contact B. Laura D. Seneff, RAC Laurager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX #### Device Name C. Trade Name: Pre-Loaded UltraFix® RC Common Name: Suture Anchor Fastener, Fixation, Nondegradable, soft Classification Names: tissue Proposed Class/Device: Class II, MBI Product Code {1}------------------------------------------------ Summary of Safety and Effectiveness Summary UltraFix® RC Kol3553 510(k) # _ October 23, 2001 Page 2 of 2 ### Predicate/Legally Marketed Devices Predicate/Legally Marketed Devices D. K963812 UltraFix® RC Linvatec ## E. Device Description The Pre-Loaded UltraFix® RC is supplied sterile and consists of an the Pre-Loaded UltraFix® with USP#2 non-absorbable polyester The Pre-Loaded UltraFix® RC is supplied stenie and other Hick To suture anchor with USP#2 noreadson onto a single from suture with cartidge and needles preloaded onto a single from suture with carting The Bre-Loaded UltraFix® RC is Oltania With carridge and needles preloaded UltraFix® RC is made from disposable inserter. The Pre-Loaded UltraFix® RC is made from disposable inserter. The Pre-Loaded UltraF Suture The Fre-Loaded UntraPRS Tre-Loaded UntraPRS TRO-18 The Free States 316(L) stainless steel per ASTM F138-92 or ASTM F138-92 and 316(L) stainless steel per ASTM F138-92 conforms to ISO 5832-1. ### r. Intended Use The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff es and the site of be sither arthroscopically or in an open technique. mtendop on ## Substantial Equivalence Substantial Equivalence The Pre-loaded UltraFix® RC is substantially equivalent in design, The Pre-loaded by total use to Linvateds existing UltraFix® RC G. The Pre-loaded UltraFix® RC is substantially equivalorit works of technology and intended use to Linvated testing has been conducted to Suture Anchor System. Performance testing has been conduction in toonliness Suture Anchor System. Performance testing has boon controller in the modeling the modeling the model safety and effectiveness. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle with three stylized lines representing its wings, and a wavy line below, possibly representing water or a ribbon. The logo is printed in black and white. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 1 9 2001 Ms. Laura Seneff Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Re: K013553 K013535 Trade/Device Name: Pre-Loaded UltraFix® RC Trade/Device Name: Pre-Loaded UltraFix® RC Coade/Device Name: CAR 2019 2010 Trade/Device rumber: 21 CFR 888.3040 Regulation Number: 21 CFF 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener T Regulatory Class: Class II Product Code: MBI Dated: October 23, 2001 Received: October 25, 2001 Dear Ms. Seneff: Dour reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 5 I (K) prematics not incent of the indications referenced above and have determined the device is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market device Institute America Amendments, or to commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactment and of ho received by the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of the Feder devices that have been reclassified in accordance with the proval online to more of the Act. and Cosmetic Act (Act) that do not require approval of a premarket approval optiv and Cosmetic Act (Act) that do not require approval or approval or the Act. The You may, therefore, market the device, subject to the general controls of the Act. The Act You may, therefore, market the device, subject to the general conner provincial controls. general controls provisions of the Act include requirements for ammanding and general controls provisions of the Act include requirements for allude organism misbranding and adulteration. at antil is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (Special Conaction of the country to comments of the can may be subject to such additional controls. Existing m may be subject to such additional controls. Existing major regalatown a literation, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, Frito 21, Children please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's ssuance of a substanted activals.ited adverseasing of the Act that FDA has made a determination that your device complies with other requires. that FDA has made a determination that your are complet Federal agencies. You must or any Federal statutes and regulations soluncian but not limited to: registration and li or any Federal statutes and regulations administed by out a ugestiration and listing (21 comply with all the Act's requirements, including, but not limited to regultents as s comply with all the Act's requirements, including, but not mines were requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 801); godd manufacture; pract and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f ap forth in the quality systems (QS) regulation (21 CFR Part 22) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {3}------------------------------------------------ Page 2 - Ms. Laura Seneff This letter will allow you to begin marketing your device as described in your Section 510(k) I allegally and the TDA Finding of substantial equivalence of your device to a This letter will allow you to begin marketing your device of your device of your device to a legally premarket notification. The in a cleasification for your device and thus, premarket notification. The FDA finding of substantial equivalite on 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 If you desire specific advice for your device on our labeling regulation of the Office of additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the It you are at (201) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4659. Additionally, for questions on the promotion and Compliance at (301) 594-4659. Additionally, for questions on and promotes of the one the your device, please contact the Office of Complance at (01) 397 (1) 37 Part 807.97). regulation entitled, "Misbranding by reference to prematket may be otained from the regulation entitled, "Mishranding by reference to premailer homments" ( Other general information on your responsibilities under the Act may be obtained from the 1984 - 1988 - 1998 - 1998 - 1998 - 1995 - 1995 - 1998 - 1998 - 1998 - 1998 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -Division of Small Mianufacturers, Incat its Internet address (800) 638-2041 or (301) 443-6597 or at its Internet in . ht (800) 638-2041 or (301) 445-6597 or ar le no no no no no http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. D/t: SWFoster:bxw:12/18/01 {4}------------------------------------------------ Page 1 of 1 October 23, 2001 510(k) Number (if known): John 3553 Device Name: Pre-Loaded UltraFix® RC Indications for Use: The Pre-Loaded UltraFix® RC is intended to be used for rotator cuff repairs in the The FTC-Eoadou Oldar of an open technique. (Division Sign-Off) Division of Gener Restorative and Neurological ... vices 510(k) Number L (Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (Per 21 CFR 801.109) Over-the-Counter Use_ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/device/K013553](https://fda.innolitics.com/device/K013553) **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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