← Product Code [HWC](/productcode/HWC) · K021254 # LACTOSORB MINI INTERFERENCE SCREW (K021254) _Biomet Orthopedics, Inc. · HWC · Jul 17, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K021254 ## Device Facts - **Applicant:** Biomet Orthopedics, Inc. - **Product Code:** [HWC](/productcode/HWC.md) - **Decision Date:** Jul 17, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization. ## Device Story LactoSorb® Mini Interference Screw is a resorbable fixation device; used for soft tissue to bone attachment in hand, wrist, and shoulder procedures. Device is preloaded on a driver; operated by surgeons in clinical settings. Provides mechanical fixation during healing; material resorbs over time. Benefit includes secure tissue-to-bone anchoring without permanent hardware. Clinical decision-making relies on surgeon assessment of fixation needs. ## Clinical Evidence No clinical data; substantial equivalence established via bench testing. ## Technological Characteristics Resorbable interference screw made of LactoSorb® material. Single-size design. Preloaded on a driver for surgical delivery. Mechanical fixation principle. ## 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 - LactoSorb® Suture Anchor ([K954443](/device/K954443.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}------------------------------------------------ K01/254 JUL 1 7 2002 Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, block letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, thinner letters. ## SUMMMARY OF SAFETY AND EFFECTIVENESS Biomet Orthopedics, Inc. Applicant or Sponsor: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Sara B. Shultz Contact Person: Telephone: (574) 267-6639 Fax: (574) 372-1683 Proprietary Name: LactoSorb® Mini Interference Screw Arthrodesis screw Common or Usual Name: Fastener, Fixation, Biodegradable, Soft Tissue Classification Name: Device Product Code: 87MAI Legally Marketed Devices To Which Substantial Equivalence Is Claimed: LactoSorb® Suture Anchor, K954443, Biomet, Inc. Indications for Use: The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization. Device Description: The LactoSorb® Mini Interference Screw is a resorbable screw that is preloaded on a driver much like those used with suture anchors. The screw is made out of LactoSorb®. The screw will be available in one size only. Summary of Technologies: The device's technological characteristics (materials, design, sizing, indications) are similar to or identical to the predicate devices. Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence. Clinical Testing: Clinical testing was not used to establish substantial equivalence. MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 m SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 OFFICE 219.267.6639 FAX 219.267.8137 E-MAIL biomet@biomet.com {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 7 2002 Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K021254 Trade/Device Name: LactoSorb® Mini Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 18, 2002 Received: April 19, 2002 Dear Ms. Shultz: 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. Iisting 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. {2}------------------------------------------------ Page 2 -- Ms. Sara B. Shultz 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 and additionally 21 CFR Part 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (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. Mark M. Wilkerson 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 {3}------------------------------------------------ Page *_/ of _*/ 510(k) NUMBER (IF KNOWN): K021554 DEVICE NAME: LactoSorb® Mini Interference Screw INDICATIONS FOR USE: The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization. Mark N Millenor Division of General, Restorative and Neurological Devices KO21259 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use you (Per 21 CFR 801.109) OR Over-The-Counter-Use No (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K021254](https://fda-staging.innolitics.com/device/K021254) **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