← Product Code [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH) · K141840 # TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH (K141840) _Zimmer, Inc. · MBH · Sep 3, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K141840 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [MBH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH.md) - **Decision Date:** Sep 3, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3565 - **Device Class:** Class 2 - **Review Panel:** Orthopedic ## Intended Use Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use. ## Device Story NexGen TM Cone Broach is a 2-piece manual orthopedic instrument (broach and handle) used by surgeons during total knee arthroplasty. Device prepares tibial metaphysis for Trabecular Metal Tibial Cone Implants. Surgeon manually impacts broach into bone using mallet, utilizing sequentially larger sizes to shape tibial canal to correct depth and geometry. Replaces manual burring steps; streamlines surgical workflow. Output is prepared bone cavity matching implant dimensions. Benefits patient by ensuring accurate fit for tibial cone implants, facilitating stable joint reconstruction. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics 2-piece manual orthopedic instrument (broach and handle). Material: 17-4 stainless steel. Operation: Manual, sequential impaction with mallet. Non-sterile, reusable. Design mimics existing cone implants to ensure anatomical fit. ## Regulatory Identification A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate. ## Special Controls *Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance. ## Predicate Devices - Trabecular Metal Tibial Cone Augments ([K102896](/device/K102896.md)) - NexGen Trabecular Metal Coupled Tibial Cones ([K120990](/device/K120990.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and are connected by flowing lines. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 3, 2014 Zimmer, Incorporated Ms. Diana Taylor Regulatory Affairs Senior Specialist P.O. Box 708 Warsaw, Indiana 46580 Re: K141840 Trade/Device Name: NexGen® Complete Knee Solutions Trabecular Metal Cone Broach Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: July 07, 2014 Received: July 08, 2014 Dear Ms. Taylor: 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 {1}------------------------------------------------ (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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/ReportaProblem/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 Industry and Consumer Education 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 yours, # Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K141840 Device Name NexGen® Complete Knee Solutions Trabecular Metal Cone Broach #### Indications for Use (Describe) Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use. #### Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary | Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Diana Taylor
Regulatory Affairs
Telephone: (574) 267-6131
Fax: (574) 372-4605 | | Date: | July 7, 2014 | | Trade Name: | NexGen® Complete Knee Solutions Trabecular Metal
Cone Broach | | Common Name: | Broach | | Classification: | Class II Accessory
21 CFR 21 888.3560 and 21 CFR 888. 3565 | | Product Code: | JWH and MBH | | Classification Panel: | Orthopedics | | Predicate Device(s): | Trabecular Metal Tibial Cone Augments manufactured by
Trabecular Metal Technologies, K102896, 12/13/2010 | | | NexGen Trabecular Metal Coupled Tibial Cones
manufactured by Trabecular Metal Technologies, K120990,
06/29/2012. | | Description: | The NexGen TM Cone Broach, a 2-piece instrument (Broach
and Handle), are manufactured from 17-4 stainless steel and
designed to provide a multi-functional instrument to
streamline the surgical process used when implanting the
Trabecular Metal Tibial Cone Implants. | | | The broaches are used to prepare the tibial metaphysis; the
broach have teeth that are necessary to cut through bone and
form the tibial canal to the correct shape and depth for a
Trabecular Metal Tibial Cone Implant. The broaches are
manually impacted, using a sequentially larger broach until
reaching the final size for the Implant. | {4}------------------------------------------------ - Indications for Use: Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use. - Comparison to Predicate: Both the NexGen TM Cone Broach and the predicate broach are non-sterile, reusable manual orthopedic instruments that perform the same function as the predicate, are manufactured from identical materials, design mimics the currently marketed cone implants in order to prepare the tibial canal for Trabecular Metal Cone Implants using the same principal of operation (manual, sequential impaction with a mallet). The addition of design specific Coupled broaches and Large broach sizes provides design specific instrumentation for the full line of Cone Implants. The Large broach replaces a challenging manual burring step. The additional functionality of the instrumentation allows the surgical procedure to be streamlined. The TM Cone Broach is as safe and effective as the predicate instrumentation used to implant the Coupled, Medium and Large Trabecular Metal Cone Implants. - Substantial Equivalence Zimmer considers this 2-piece broach equivalent to the Conclusions predicate one-piece broach based on design, size range and performance. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K141840](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBH/K141840) **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