← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K063584 # STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 (K063584) _Regeneration Technologies, Inc. · HWC · May 9, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K063584 ## Device Facts - **Applicant:** Regeneration Technologies, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** May 9, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT. ## Device Story Sterling IF Screw Eyelet is a bovine bone-derived fixation device; used for securing soft tissue grafts (ligaments/tendons) during cruciate ligament reconstruction. Device features 25mm x 8mm dimensions with an oval eyelet. Designed for use in conjunction with Sterling Interference Screw HT (K060253). Operates as a mechanical fixation component; implanted by surgeons during orthopedic procedures. Benefits include biological graft fixation in reconstructive surgery. ## Clinical Evidence No clinical data. Bench testing included a viral inactivation study using a worst-case representation of the BioCleanse Tissue Sterilization Process, demonstrating reduction of a viral panel to below detectable limits. ## Technological Characteristics Material: Bovine bone from U.S. closed herd. Processing: BioCleanse Tissue Sterilization Process. Dimensions: 25mm length, 8mm width, oval eyelet. Mechanical fixation device. ## 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 - LinX HT - Sterling Interference Screw ST - Sterling Interference Screw HT ([K060253](/device/K060253.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}------------------------------------------------ # Regeneration Technologies, Inc. K063584 STERLING® IF Screw Evelet # 510(K) Summarv ### MAY - 9 2007 Date: May 4, 2007 Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: 386-418-8888 x4326 Fax: 386-462-1627 Proprietary Name: Sterling® IF Screw Eyelet Common Name: soft tissue graft fixation device Product Code: HWC. Orthopedics Panel Code Section: 21 CFR 888.3040 #### Substantial Equivalence: The Sterling IF Screw Eyelet is substantially equivalent to the LinX HT in design and function, and substantially equivalent to the Sterling Interference Screw ST and Sterling Interference Screw HT in materials and function. ### Description: The Sterling IF Screw Eyelet is manufactured from bovine bone processed with the BioCleanse® Tissue Sterilization Process. The Sterling IF Screw Eyelet is 25mm long by 8mm wide with an oval eyelet. The subject Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT cleared via K060253. #### Intended Use: This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT. ## Summary of Technological Characteristics: The Sterling IF Screw Eyelet, Sterling Interference Screw ST and Sterling Interference Screw HT are composed of the same materials processed in the same manner. The source of bovine bone used in the manufacture of the Sterling IF Screw Eyelet is a closed herd located in the U.S.A. A viral inactivation study using a worst-case representation of the BioCleanse® Tissue Sterilization Process, used in the manufacture of the Sterling IF Screw Eyelet, has shown a reduction of a panel of viruses to below detectable limits. {1}------------------------------------------------ Public Health Service OF HEALTH & HUMAN SERVICES · USA Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Regeneration Technologies, Inc. % Ms. Lisa Simpson Director of Regulatory Affairs 11621 Research Circle Alachua, Florida 32616-2650 MAY - 9 2007 Re: K063584 Trade/Device Name: Sterling® IF Screw Eyelet Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, JDR Dated: April 20, 2007 Received: April 23, 2007 Dear Ms. Simpson: 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Lisa Simpson 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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbari bucherp Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use 510(k) Number (if known): K063584 Device Name: Sterling® IF Screw Eyelet Indications for Use: This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT. Over-The-Counter Use Prescription Use X AND/OR · (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Laubare Buckup (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K063584 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K063584](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K063584) **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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