← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K033871 # IM TOTAL FEMUR (K033871) _Biomet, Inc. · JDI · Apr 16, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K033871 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Apr 16, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The device is intended to be implanted with bone cement in cases of: 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques 7. Revision of previously failed total joint replacement 8. Trauma ## Device Story IM Total Femur is an intramedullary rod system connecting proximal hip replacement components to knee femoral replacement components. Rods are slightly bowed to mimic natural femur anatomy; feature male tapers at both ends for modular connection to hip and knee components; secured via locking screw after impaction. Available in two taper configurations (Impact/OSS or Impact/Impact) with varying lengths. Used in orthopedic surgery for total hip and knee joint reconstruction. Surgeon selects appropriate rod based on distal knee component taper. Device articulates with previously cleared tibial bearings, base-plates, and femoral components. Provides structural support for patients with severe joint disease, trauma, or tumor resection; restores joint function and alignment. ## Clinical Evidence No clinical data provided. Bench testing only; mechanical testing confirmed taper integrity under expected loading conditions. ## Technological Characteristics Intramedullary rod system; modular design with male tapers; slightly bowed geometry. Materials, design, and indications are similar to predicate oncology/salvage systems. Cemented fixation. No software or electronic components. ## Regulatory Identification A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Oncology Salvage System ([K002757](/device/K002757.md)) - Salvage/Oncology Hip and Total Femur System ([K974558](/device/K974558.md)) - Barrago Cystem ([K915132](/device/K915132.md)) - Biomet SCK Knee System ([K015132](/device/K015132.md)) - Biomet SCK Knee System ([K003296](/device/K003296.md)) - AVL Hinged Knee ([K010774](/device/K010774.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}------------------------------------------------ APR 1 6 2004 K033871 (pg 1 of 2) BIOMET ### 510(k) Summary Applicant/Sponsor: Biomet Manufacturing Corp. Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist Proprietary Name: IM Total Femur Common or Usual Name: Oncology, Salvage Hip/Knee #### Classification Name: - 1. Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (21 CFR Part 888.3350) - 1. Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, (21 CFR Part 888.3510) - 3. Poosthesis, Knee, PatelloFemorotibial, Semi-constrained, Polymer/Metal/Polymer, cemented (21 CFR Part 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Oncology Salvage System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Barrago Cystem (K915132), Biomet SCK Knee System (K015132), Biomet SCK Knee System (K003296), AVL Hinged Knee (K010774). Device Description: The IM Total Femur is, in simplest terms, an intramedullary (IM) rod which connects a proximal hip replacement component to a knee femoral replacement component. The IM rods are slightly bowed to mimic the natural femur and find appropriate alignment. Both ends of the rod have a male taper for connection to the hip proximal femur and a knee femoral component. Following impaction, a locking screw further secures the parts. Two types of IM rods are available based on the tapers of the distal knee component selected by the surgeon. IM total femur rods with an "Impact" taper at one end and an "OSS" taper at the other come in 1cm increments for replacements of 35cm to 45cm. The second type of rod have an "Impact" taper at both ends and come in 3cm increments for replacement from 34 to 46cm. > MAILING ADDRESS 120 Box 5247 Warsaw. IN 46581 058 ? SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582 (DEFFICT) 57 4 207 (16 (16) 34) 145 E Min Biomers bionnet.son {1}------------------------------------------------ K033871 (pg 2 of 2) IM Total Femur 510(k) Summary Page 2 Femoral knee components are available with both "OSS" and "Impact" taper bores. The r omoral know components articulate with previously cleared tibial bearings, base-plates and forhordi oomponents. The device is compatible with any of Biomet's proximal modular hip components. Intended Use: The device is intended to be implanted with bone cement in cases of: - 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis - 2. Correction of varus, valgus or post traumatic deformity - 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - 4. Ligament deficiencies - 5. Tumor resections - 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques - 7. Revision of previously failed total joint replacement - 8. Trauma Summary of Technologies: The IM Total Femur components (materials, design and indications) are similar or identical to the predicate devices. Non-Clinical Testing: Mechanical testing has shown the tapers capable of withstanding expected loading conditions. Clinical Testing: None provided All tradernarks are property of Biomet, Inc. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle or other bird-like figure. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 1 6 2004 Ms. Patricia Sanborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K033871 Trade/Device Name: IM Total Femur Regulation Number: 21 CFR 888.3350, 21 CFR 888.3510, 21 CFR 888.3560 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Knee joint femorotibial metal/polymer constrained cemented prosthesis, K nee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, KRO, JWH Dated: March 22, 2004 Received: March 23, 2004 Dear Ms. Beres: 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 10 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 gencral 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 Codc 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ## Page 2 - Ms. Patricia Sanborn Beres 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Sincerely yours, 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K033871 Device Name: IM Total Femur Indications For Use:Total hip and knee joint replacement in cases of: - Indications For Southing from avascular necrosis, osteoarthritis, theumatoid arthritis, traumatic arthritis - 2. Correction of varus, valgus or post traumatic deformity - 2. Corroction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement - 4. Ligament deficiencies - 5. Tumor resections - 6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques - 7. Revision of previously failed total joint replacement - 8. Trauma Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for Mark N. Wilkerson Division of General, Restorative. 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