← Product Code [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI) · K982095 # LACTOSORB MENISCAL REPAIR DEVICE (K982095) _Biomet, Inc. · MAI · Jan 27, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K982095 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI.md) - **Decision Date:** Jan 27, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The LactoSorb® Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus. ## Device Story Bioresorbable meniscal repair device; composed of synthetic polylactic/polyglycolic acid copolymer. Device implanted by surgeon during orthopedic procedures to approximate meniscal tissue. Material degrades in vivo via hydrolysis into lactic and glycolic acids, which are metabolized by the body. Intended to provide mechanical fixation for tissue healing; eliminates need for permanent implant removal. Used in clinical settings by orthopedic surgeons. ## Clinical Evidence Bench testing only. In vitro testing demonstrated performance equivalent to resorbable predicate devices for meniscal tissue approximation. Biocompatibility supported by prior animal and clinical studies of the copolymer material. ## Technological Characteristics Material: Polylactic/polyglycolic acid copolymer (synthetic polyester). Principle: Bioresorbable fixation via hydrolysis. Form factor: Meniscal repair device. Sterilization: Not specified. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## 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}------------------------------------------------ ## K98 2095 ## JAN 27 1999 Summary of Safety and Effectiveness 510 (K) Biomet, Inc. Submitter: P.O. Box 587 Airport Industrial Park Warsaw, IN 46580-0587 Mary L. Verstynen Contact Person : Product Code: MAI LactoSorb® Meniscal Repair Device Device Name: LactoSorb® Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus. The LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic Polylactic/polyglycolic acid copolymer degrades acids. and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue. IN VITRO testing demonstrated that the LactoSorb® Meniscal Repair Device will perform as well as resorbable predicate devices indicated for use in Meniscal tissue approximation. 00004 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or symbol, composed of three curved lines that resemble a human profile. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 27 1999 Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. Airport Industrial Park P.O. Box 587 46581-0587 Warsaw, Indiana K982095 Re: LactoSorb® Meniscal Repair Device Trade Name: Regulatory Class: II Product Codes: MAI and GAM Dated: December 17, 1998 December 18, 1998 Received: ## Dear Ms. Verstynen: 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 - Ms. Mary L. Verstynen 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other qeneral 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.gov/cdrh/dsmamain.html". Sincerely yours, 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}------------------------------------------------ 510 (k) NUMBER (IF KNOWN) : LactoSorb Meniscal Repair Device DEVICE NAME: INDICATIONS FOR USE: The LactoSorb Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) (Division Sign-Off) General Restorative Devi Division of 510(k) Numb 00003 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K982095](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K982095) **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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