← Product Code [HRS](/productcode/HRS) · K013657 # MODIFICATION TO: BIOMET HUMERAL CABLE PLATES (K013657) _Biomet Orthopedics, Inc. · HRS · Dec 3, 2001 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K013657 ## Device Facts - **Applicant:** Biomet Orthopedics, Inc. - **Product Code:** [HRS](/productcode/HRS.md) - **Decision Date:** Dec 3, 2001 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization. ## Device Story The Biomet® Humeral Cable Plate is a metallic bone fixation system designed for orthopedic surgical use. It consists of two straight 316LVM stainless steel plates of varying lengths (156mm and 206mm) featuring integrated cable crimp sleeves and cortical screw holes. The device is used by surgeons to stabilize humeral fractures, particularly in cases involving existing intramedullary implants. The system utilizes 3.5mm cortical screws and 2.0mm diameter BMP™ cable cerclage. By combining screw fixation with cerclage cabling, the device provides enhanced mechanical stabilization of the fracture site, facilitating bone healing and improving patient outcomes in complex fracture scenarios. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on bench testing, specifically finite element analysis and literature review. ## Technological Characteristics Material: 316LVM Stainless Steel (ASTM F138). Components: Two straight plates (156mm and 206mm) with integrated cable crimp sleeves and cortical screw holes. Fixation: 3.5mm cortical screws and 2.0mm diameter BMP™ cable cerclage. Mechanical fixation principle. ## 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 - Biomet's BMP™ Cable System ([K982545](/device/K982545.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}------------------------------------------------ DEC 0 3 2001 Image /page/0/Picture/1 description: The image shows the Biomet corporate headquarters logo. The logo is a stylized version of the word "BIOMET" in bold, block letters. The words "CORPORATE HEADQUARTERS" are printed in a smaller font below the logo. The text "K01365 page 1 of" is handwritten in the upper right corner of the image. ## SUMMARY OF SAFETY AND EFFECTIVENESS | Sponsor: | Biomet Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0587 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tracy J. Bickel
(219) 267-6639 | | Proprietary Name: | Biomet® Humeral Cable Plate | | Common Name: | Bone Plate | | Classification Name: | Bone, Fixation, Cerclage 888.3010
Plate, Fixation, Bone 888.3030 | | Substantially Equivalent Device: | Biomet's BMPTM Cable System- K982545 | | Device Description: | The Biomet® Humeral Cable Plate System consists of two (2) 316LVM Stainless
Steel (ASTM F138) Plates. The plates are straight and have a combination of
cortical screw holes and integrated cable crimp sleeves. The first plate is 156mm
in length and has six (6) cable crimps and five (5) alternating cortical screw holes.
The second plate is 206mm in length with eight (8) cable crimps alternating with
seven (7) cortical screw holes. Both plates will utilize 3.5mm Cortical Screws and
standard 2.0mm Diameter 316LVM Stainless Steel BMPTM Cable Cerclage. | | Intended Use: | Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization. | | Summary of Technologies: | The Biomet® Humeral Cable Plate's material, design, sizing, and
indications are similar or identical to the predicate devices. | | Non-clinical Testing: | Finite Analysis and literature review determined that the Biomet®
Humeral Cable Plate presented no new risks and were therefore,
substantially equivalent to the predicate device. | | Clinical Testing: | None provided as a basis for substantial equivalence. | All trademarks are property of Biomet, Inc. MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 . 0000039 OFFICE 219.267.6639 FAX = E-MAIL biomet@biomet.com {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the circle. The eagle is depicted in black, and the text is also in black against a white background. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 0 3 2001 Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581 Re: K013657 Trade/Device Name: Biomet® Humeral Cable Plate Regulation Number: 888.3010, 888.3030 Regulation Name: Bone fixation cerclage Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDO, HRS Dated: November 5, 2001 Received: November 6, 2001 Dear Ms. Bickel: 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ ## Page 2 - Ms. Tracy J. Bickel This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your e FDA finding of substantial equivalence of your device to a legally promated noticated 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 additionally 21 301) 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, for Mark N. Millican 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): K013457 Device Name: Biomet® Humeral Cable Plate Indications for Use: - Fixation of a humeral fracture near the site of an intramedullary implant. . - Fixation of a numeral fracture near the eno eno eno enough the would improve . stabilization. (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) Division of General, Restorative and Neurological Devices K01365-7 (k) Number 000008 --- **Source:** [https://fda-staging.innolitics.com/device/K013657](https://fda-staging.innolitics.com/device/K013657) **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