← Product Code [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN) · K132510 # BIOPRO - INFINITY PLATE ANCHOR SYSTEM (K132510) _Biopro, Inc. · HTN · Oct 24, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K132510 ## Device Facts - **Applicant:** Biopro, Inc. - **Product Code:** [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN.md) - **Decision Date:** Oct 24, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'single-use' only. The system is not intended for spinal use. ## Device Story The BioPro Infinity™ Plate Anchor System is a metallic bone fixation system used for ligament reattachment or fixation. The system consists of various plates (2-hole curved, 1-hole 10/12/14mm, 3-hole flat straight, and 3-hole T-plate) and 3.0mm cancellous screws (15mm and 20mm lengths). The device is used in a surgical setting by a physician to secure soft tissue to bone. The system is provided sterile for single-use and includes disposable ancillary instrumentation (screwdriver and K-wire) for implantation and removal. The device provides mechanical stabilization of ligaments to facilitate healing. ## Clinical Evidence No clinical data. Bench testing only. ## Technological Characteristics Materials: 6-4 Alloyed Titanium per ASTM F136. Surface treatment: Anodize Type II. Components: Multiple plate configurations and 3.0mm cancellous screws. Sterilization: Ethylene Oxide. Single-use, sterile. No software or electronic components. ## 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. ## Predicate Devices - Synthes - Metallic Spiked Washers ([K013806](/device/K013806.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}------------------------------------------------ BioPro, Inc. - Infinity™ Plate Anchor System - K132510 - 510{k} Summary: ." ## 510(k) Summary of Safety and Effectiveness SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary | NAME OF FIRM: | BioPro, Inc.
2929 Lapeer Road
Port Huron, MI 48060
www.bioproimplants.com | OCT 24 2013 | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-mail: allippincott@msn.com | | | DATE: | July 31, 2013 | | | TRADE NAME: | BioPro - InfinityTM Plate Anchor System | | | COMMON NAME: | Soft-tissue Fixation Plate and Screw | | | DEVICE NAME: | Fastener, Soft-tissue
Washer, Bolt Nut
Screw, Fixation, Bone | | | CLASSIFICATION: | Single/multiple Component Metallic Bone Fixation Appliances and
Accessories, Class II (21CFR, Sec. 888.3030)

Smooth or Threaded Metallic Bone Fixation Faxtener,
Class II (21 CFR, Sec. 888.3040) | | | DEVICE PRODUCT CODE: | HTN | | | SUBSEQUENT PRODUCT CODE: | HWC | | | SUBSTANTIALLY
EQUIVALENT DEVICE | Synthes - Metallic Spiked Washers (K013806) | | Section XII {1}------------------------------------------------ DEVICE DESCRIPTION: The BioPro- Infinity™ Plate Anchor System is a multiple plate system composed of a: 1). 2-hole Curved Plate, 2). 1-hole 10mm Plate, 3). 1-hole 12mm Plate, 4). 1-hole 14mm Plate, 5). 3-hole Flat Straight Plate, and 6). 3-hole T-Plate. Two(2) 3.0mm Cancellous Screws in a 15mm and 20mm length accompany the system for fixing the plate through soft-tissue to bone. Both the plates and screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. Ancillary screwdriver and K-wire instrumentation is offered as 'sterile' and disposable and is made available for implantation and removal of the device. The plate and screw implant combination with instrumentation is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide. The BioPro - Infinity™ Plate Anchor System is indicated for ligament INTENDED USE: reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'single-use' only. The system is not intended for spinal use. The BioPro - Infinity™ Plate Anchor System is Substantially EQUIVALENCE: Equivalent(SE) to the predicate system listed. SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS The BioPro - Infinity™ Plate Anchor System is Similar in Material, Geometry Design/Markings, and Indications to the Synthes Metallic Spike Washers currently sold in the U.S. market. #### SUMMARY OF SAFETY AND EFFECTIVENESS: The BioPro - InfinityTM Plate Anchor System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three figures connected by flowing lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 24, 2013 BioPro, Incorporated % Mr. Al Lippincott Engineering Consulting Services, Incorporated 3150 East 200th Street Prior Lake, Minnesota 55372 Re: K132510 Trade/Device Name: BioPro - Infinity" Plate Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: October 8, 2013 Received: October 16, 2013 Dear Mr. Lippincott: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical {3}------------------------------------------------ ### Page 2 - Mr. Al Lippincott device-related adverse events) (21 CFR 803): 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. # Erin Keith for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use ## 510(k) Number: DEVICE NAME: BioPro - Infinity™ Plate Anchor System The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'singleuse' only. The system is not intended for spinal use. AND/OR XXXX Over-The-Counter-Use Prescription Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ## Elizabeth L. Frank -S Division of Orthopedic Devices Section XI Page 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K132510](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K132510) **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