← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K021832 # ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER (K021832) _Biomet, Inc. · HWC · Jun 26, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K021832 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 26, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer is indicated for the following procedures: 1. ACL and PCL reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. Iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality. ## Device Story Resorbable bone fixation system comprising 6.5 mm diameter screw (25-55 mm lengths) and 18 mm diameter washer with eight distal spikes; used in orthopedic ligament and tendon repair procedures; provides mechanical fixation for soft tissue to bone; intended for use by orthopedic surgeons in clinical settings; serves as primary or back-up fixation; aids in stabilization during healing; material resorbs over time. ## Clinical Evidence No clinical data provided; substantial equivalence established via non-clinical bench testing. ## Technological Characteristics Material: 85% L-Lactide/15% Glycolide high-viscosity copolymer. Components: 6.5 mm screw, 18 mm diameter washer with eight spikes. Manufacturing: Machined screw, injection-molded washer. Non-metallic, resorbable fixation. ## 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 - Resorbable No Profile Screw and Washer, Biomet, Inc. ([K012469](/device/K012469.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}------------------------------------------------ K021832 JUN 2 6 2002 Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The logo is in black and white. The word "BIOMET" is in a stylized font with a box around the "B" and lines through the "E" and "T". Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, sans-serif font. ## SUMMARY OF SAFETY AND EFFECTIVENESS | Applicant or Sponsor: | Arthrotek, Inc.
(A wholly owned subsidiary of Biomet, Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Sara B. Shultz
Biomet Orthopedics, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, IN 46582
Phone: (574) 267-6639
FAX: (574) 372-1683 | | Proprietary Name: | Arthrotek Resorbable No-Profile
LactoSorb® L-15 Screw and Washer | | Common Name: | Resorbable screw and washer | | Classification Name: | Screw, Fixation, Bone, Non-spinal, Non-
metallic (888.3040)
Washer, Bolt Nut, Non-spinal, Non-metallic
(888.3030) | | Device Product Code: | 87HWC and HTN | Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable No Profile Screw and Washer, Biomet, Inc. (K012469). Intended Use: The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer is indicated for the following procedures: - 1. ACL and PCL reconstruction - 2. Medial collateral ligament repair - 3. Lateral collateral ligament repair - 4. Posterior oblique ligament repair - 5. Iliotibial band tenodesis reconstruction - 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality. | MAILING ADDRESS | SHIPPING ADDRESS | | | | | |-----------------------------------------------------------------------|------------------|--------------|--------------------------------------------------------------------|-----|--------------| | P.O. Box 587 | 56 E. Bell Drive | | | | | | Warsaw, IN 46581-0587 | Warsaw, IN 46582 | | | | | |
OFFICE
219.267.6639
| OFFICE | 219.267.6639 |
FAX
219.267.8137
| FAX | 219.267.8137 | | OFFICE | | | | | | | 219.267.6639 | | | | | | | FAX | | | | | | | 219.267.8137 | | | | | | bioE-MAIL biomet@ki…… {1}------------------------------------------------ page 2/2 Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the next. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, serif font. Device Description: The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer with eight spikes on the distal surface. The screw is machined from an 85% L-Lactide/15% Glycolide material that is a high viscosity copolymer. The washer is injection molded from the same material. Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate. Clinical Testing: Clinical testing was not used to establish substantial equivalence. MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 . SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 1 OFFICE 219.267.6639 l·Ax 219.267.8137 biomet E-MAIL Image /page/1/Picture/10 description: The image shows the number 00068 in a bold, sans-serif font. The numbers are aligned horizontally and are of uniform size. The background is plain and white, which makes the numbers stand out. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered on the image and is the only element in the image. The text is likely the header of a document or website. Image /page/2/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 eagle with three heads in profile, facing right. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUN 2 6 2002 Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K021832 Trade/Device Name: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 3, 2002 Received: June 4, 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, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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, Celia M. Witten, Ph.D., M.D. 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 cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t: POSung:bxw:6/25/02 {4}------------------------------------------------ Page . 1 of 1 510 (k) Number (if known) : K021832 DEVICE NAME: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer ## INDICATIONS FOR USE: The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer is indicated for the following procedures: - 1. ACL and PCL reconstruction - 2. Medial collateral ligament repair - 3. Lateral collateral ligament repair - 4. Posterior oblique ligament repair - 5. Iliotibial band tenodesis reconstruction - 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality. for Mark N. Mulkeron Division Sign-C Di- ision of General, Restorative and Neurological Devic 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 (Per 21 CFR 801.109 OR Over-The-Counter-Use NO (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K021832](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K021832) **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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