← Product Code [MEH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH) · K961732 # KAR (K961732) _Landos, Inc. · MEH · Jul 8, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K961732 ## Device Facts - **Applicant:** Landos, Inc. - **Product Code:** [MEH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH.md) - **Decision Date:** Jul 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The KAR Hip Prosthesis is recommended for revision cases. It is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. ## Device Story KAR Revision Hip Prosthesis is a non-cemented, long femoral stem designed for revision hip arthroplasty. Device features Ti-6Al-4V construction with hydroxyapatite coating; straight stem with quadrangular cross-section; blunt corners; metaphyseal widening with bi-dimensional flare; horizontal/vertical grooves for stability. Distal section provides anchor; cross-slotted tip allows elasticity and femoral curve adaptability. Device utilizes 12/14 Morse-like taper. Implanted by orthopedic surgeons in clinical/OR settings. Provides mechanical interlock for femoral component fixation in patients with sufficient cortical bone. Benefits include restoration of joint function and pain relief in revision scenarios. ## Clinical Evidence Clinical studies compared KAR femoral stem to Corail and Osteonics Restoration Monolithic Hip. Results showed KAR has comparable success rates to Corail and fewer post-operative complications with better Postel Merle D-Aubigne scores than the Osteonics predicate. ## Technological Characteristics Material: Ti-6Al-4V; hydroxyapatite coating. Design: Long femoral stem, quadrangular cross-section, metaphyseal grooves, cross-slotted distal tip. Connection: 12/14 Morse-like taper (5°42'30" trunnion). Fixation: Press-fit (mechanical interlock). ## Regulatory Identification A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. ## Predicate Devices - Osteonics Restoration Monolithic Hip - Implex F-220 Press-Fit Femoral System - Landanger-Landos Corail Hip ## Reference Devices - Alumina femoral heads ([K905298](/device/K905298.md)) - Alumina femoral heads ([K933567](/device/K933567.md)) - Alumina femoral heads ([K932935](/device/K932935.md)) - Alumina femoral heads ([K933108](/device/K933108.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} K-101732 # SUMMARY OF SAFETY AND EFFECTIVENESS **MANUFACTURER IDENTIFICATION:** Landanger-Landos Z.I. La Vendue BP 88 52003 Chaumont FRANCE JUL - 8 1997 **SPONSOR IDENTIFICATION:** Cheryl Hastings Manager, Clinical Affairs DePuy Orthopaedics, Inc. P.O. Box 988 Warsaw, IN 46581-0988 **ESTABLISHMENT REGISTRATION NUMBER:** 1818910 **PROPRIETARY NAME:** KAR Revision Hip Prosthesis **PRODUCT CLASSIFICATION CODE:** 87 MEH **PROPOSED REGULATORY CLASS:** Class II **PREDICATE DEVICES:** Osteonics Restoration Monolithic Hip Implex F-220 Press-Fit Femoral System Landanger-Landos Corail Hip **DESCRIPTION:** The KAR Revision Hip is a non-cemented, long femoral stem made from Ti-6Al-4V, completely coated with hydroxyapatite. It has a straight stem with a quadrangular cross-section and blunt corners. The metaphyseal widening presents a bi-dimensional flare and horizontal and vertical grooves for metaphyseal support. The step-like structure of the grooves in the metaphyseal section provides stability. The distal section has symmetrical slopes. The length of the diaphyseal section provides a distal anchor while the distal cross-slotted tip allows for elasticity in the stem and adaptability to the femoral curve. The stem has a 12/14 Morse-like taper. **INDICATIONS AND INTENDED USE:** The KAR Hip Prosthesis is recommended for revision cases. It is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. **SUMMARY OF CLINICAL DATA:** Clinical studies indicate that the KAR femoral stem, a revision version of the Corail femoral stem, has a comparable success rate to the Corail. Compared to the Osteonics Restoration Monolithic Hip Stem, the KAR had fewer post-operative complications and better Postel Merle D-Aubigne scores. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Cheryl Hastings Manager, Clinical Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K961732 Trade Name: KAR Hip Prosthesis Regulatory Class: II Product Codes: LZO and MEH Dated: June 5, 1997 Received: June 9, 1997 JUL - 8 1997 Dear Ms. Hastings: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations: 1. The package insert must reflect that the the KAR Hip Prosthesis, made of Ti 6 Al-4V, with 5°42'30" Morse taper trunnion only be used with the cobalt chrome femoral heads described within this submission, or Alumina femoral heads cleared under K905298, K933567, K932935, or K933108; and 2. You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support {2} Page 2 - Ms. Cheryl Hastings equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only). Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 809.10 for in vitro diagnostic devices), please contact the Office of {3} Page 3 - Ms. Cheryl Hastings 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} 510(k) Number (if known) K961732 Device Name KAR Revision Hip Prosthesis Indications for Use: This prosthesis is intended for use as a press-fit femoral hip prosthesis where there is evidence that there is sufficient healthy cortical bone to seat the femoral component. This prosthesis is indicated for use in the following conditions: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; or failed previous surgery including joint reconstruction, internal fixation, arthrodeses, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. Concurrence of CDRH, Office of Device Evaluation ![img-1.jpeg](img-1.jpeg) Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K961732](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K961732) **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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