← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K970846 # 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD (K970846) _Landos, Inc. · LZO · Jun 5, 1997 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970846 ## Device Facts - **Applicant:** Landos, Inc. - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Jun 5, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The intended use for the 22.2/+4 Femoral Head is to complete the assembly of a Ti-6Al-4V semi-constrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction. ## Device Story The 22.2/+4 Femoral Head is a prosthetic component designed to interface with a 9/11 Morse-like taper on a Ti-6Al-4V semi-constrained femoral hip stem. It is available in zirconia ceramic or cobalt chrome alloy. The device is used by orthopedic surgeons during hip arthroplasty procedures to restore joint function. It functions as a mechanical bearing surface within the hip joint assembly. Clinical benefit is derived from replacing diseased or damaged hip joint structures to alleviate pain and improve mobility. ## Clinical Evidence Bench testing only. Burst load testing performed to compare zirconia and cobalt chrome femoral heads against the predicate device; results showed substantial equivalence. ## Technological Characteristics Materials: Zirconia ceramic or cobalt chrome alloy. Interface: 9/11 Morse-like taper (specifically 5°43'30"-0-5' taper trunnions for zirconia). Dimensions: 22.2mm diameter, +4mm neck length. Intended for use with Ti-6Al-4V femoral hip stems. ## 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 - Morphometric Total Hip Prosthesis ([K935185](/device/K935185.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} 06/02/97 17:32 219 267 7098 JUN - 5 1997 K170846 # SUMMARY OF SAFETY AND EFFECTIVENESS ## MANUFACTURER IDENTIFICATION: Landanger-Landos Z.I. La Vendue BP 88 52003 Chaumont FRANCE ## SPONSOR IDENTIFICATION: Cheryl Hastings Manager, Clinical Affairs DePuy Orthopaedics, Inc. P.O. Box 988 Warsaw, IN 46581-0988 ## ESTABLISHMENT REGISTRATION NUMBER: 1818910 ## PROPRIETARY NAME: 22.2/+4mm Femoral Heads ## PRODUCT CLASSIFICATION CODE: 87 LZO ## PROPOSED REGULATORY CLASS: Class II ## PREDICATE DEVICES: Morphometric Total Hip Prosthesis (K935185) ## DESCRIPTION: The 22.2/+4 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy. ## INDICATIONS AND INTENDED USE: The intended use for the 22.2/+4 Femoral Head is to complete the assembly of a Ti-6Al-4V semi-constrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction. ## SUMMARY OF TESTING DATA: The burst load average for both the zirconia and cobalt chrome heads is substantially equivalent to that of the predicate device. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 1997 Ms. Cheryl Hastings Manager, Clinical Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K970846 22.2/+4 Femoral Head (Co-Cr Alloy or Zirconia) for use with Morphometric Hip Stem K935185 Regulatory Class: II Product Codes: LZO and JDI Dated: March 5, 1997 Received: March 7, 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 limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads are to be used only with Ti-6Al-4V Morphometric hip stems with the 5°43'30"-0-5' Morse taper trunnions. 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. {2} Page 2 - Ms. Cheryl Hastings 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 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 {3} Page 3 - Ms. Cheryl Hastings 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} 06/02/97 17:31 219 267 7099 510(k) Number (if known) K970846 Device Name 22.2/+4 Femoral Head Indications for Use: The intended use for the 22.2/+4 Femoral Head is to complete the assembly of a Ti-6Al-4V semi-constrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction. Concurrence of CDRH, Office of Device Evaluation ![img-1.jpeg](img-1.jpeg) Prescription Use ☑ OR Over-The Counter Use --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970846](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K970846) **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