← Product Code [JWH](/productcode/JWH) · K024037 # NARROW ASCENT INTERLOK FEMORAL COMPONENTS (K024037) _Biomet, Inc. · JWH · Dec 30, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K024037 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JWH](/productcode/JWH.md) - **Decision Date:** Dec 30, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2) Correction of varus, valgus, or posttraumatic deformity. 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure. The device is indicated for implantation with cement. ## Device Story Narrow Ascent™ Interlok® Femoral Component is a cemented, semi-constrained knee replacement prosthesis. It serves as a primary femoral component for total knee replacement, designed to be used with Ascent™ tibial components and patella. The device is manufactured from cast cobalt alloy (Co-Cr-Mo). Compared to the predicate Ascent™ Primary Interlok® Femur, this version features a reduced medial-lateral width (approximately 4mm total reduction, 2mm per condyle) to prevent device overhang in patients with naturally narrow femurs. It is intended for surgical implantation by orthopedic surgeons to restore joint function and alleviate pain in patients with degenerative or traumatic knee conditions. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by engineering analysis demonstrating that design changes do not compromise component strength. ## Technological Characteristics Material: Cast cobalt alloy (Co-Cr-Mo) per ASTM F-75. Surface: Interlok® 30 grit blasted finish. Configuration: Semi-constrained, cemented femoral component. Dimensions: Medial-lateral width reduced by 4mm compared to predicate. Energy source: N/A (mechanical implant). Connectivity: N/A. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Ascent™ Primary Interlok® Femur ([K982869](/device/K982869.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}------------------------------------------------ K024037 BIOMET Page 1 of 2 # Summary of Safety and Effectiveness Applicant/Sponsor:Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 DEC 3 0 2002 - Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist Telephone: (219) 267-6639 Fax: (219) 372-1683 Proprietary Name: Narrow Ascent™ Interlok® Femoral Components Common Name: Knee replacement femoral component Classification Name: Knee joint patello-femorotibial polymer/metal/polymer semiconstrained cemented prosthesis (21 CFR 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Ascent™ Primary Interlok® Femur previously cleared in 510(k) K982869. Device Description: The Narrow Ascent™ Interlok® Femoral Components are primary femoral components intended for use with an Ascent™ tibial component and patella for total knee replacement. The device is manufactured from cast cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75 with Biomet's Interlok®, 30 grit blasted finish. Three sizes, x-small, small, and medium are available in left and right configurations. The device varies from the predicated device in that the width of the component in the medial-lateral direction has been reduced by approximately 4mm. This has been accomplished by reducing the width of each condyle by approximately 2mm. All other dimensions remain the same. A narrower femoral component is desired to avoid overhang of the device in a patient with a naturally narrow femur. > MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 > > 제 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46587 OFFICE 574.267.6639 I·AX 574.267.8137 E-MAIL biomet@biomet.com {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K od 24037", and the text at the bottom reads "page 2 of 2". The handwriting is somewhat messy, but the text is still legible. # Intended Use: - 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. - 2) Correction of varus, valgus, or posttraumatic deformity. - 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure. Summary of Technologies: The materials, design and processing of the modified device are identical to or similar to the predicate. Non-Clinical Testing: Engineering analysis was provided to demonstrate that the design change would not compromise the strength of the component. Clinical Testing: None provided. Ascent and Interlok are trademarks of Biomet, Inc. Tyvek is a trademark of E.I. duPont de Nemours and Company {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 : Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K024037 > Trade/Device Name: Narrow Ascent™ Interlok® Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 5, 2002 Received: December 6. 2002 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 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 vour 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. {3}------------------------------------------------ Page 2 - Ms. Patricia Sandborn 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 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 . ,一 Sincerely yours, Madel - 11 Maden - 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}------------------------------------------------ #### K024057 510(k) Number (if known): Device Name: Name: Narrow Ascent™ Interlok® Femoral Components Indications For Use: - - 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. - 2) Correction of varus, valgus, or posttraumatic deformity. - 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure. The device is indicated for implantation with cement. Mad. J. Walker Division Sign-Off) Division of General, Restorative and Neurological Devices 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 (Optional Format 1-2-96) 0000000 --- **Source:** [https://fda-staging.innolitics.com/device/K024037](https://fda-staging.innolitics.com/device/K024037) **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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