← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K031803 # DEPUY CERAMIC FEMORAL HEADS (K031803) _DePuy Orthopaedics, Inc. · LZO · Jul 1, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K031803 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Jul 1, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. ## Device Story DePuy Ceramic Femoral Heads serve as the articular component in total hip arthroplasty. Device consists of alumina composite femoral head with 32mm or 36mm diameters; features internal bore for interlocking with femoral hip stem (11/13 SROM or 12/14 Articul/eze tapers). Implanted by orthopedic surgeons during total hip replacement surgery to replace damaged hip joint articulation. Provides stable, load-bearing surface to restore mobility and reduce pain in patients with severe joint degeneration or trauma. Clinical benefit derived from biocompatible alumina composite material providing durable articulation against corresponding femoral hip stem. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and material similarities to predicate device. ## Technological Characteristics Alumina composite material; 32mm and 36mm head diameters; 11/13 SROM and 12/14 Articul/eze taper options; mechanical interlocking interface; non-active implant. ## 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 - DePuy Femoral Heads ([K011533](/device/K011533.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/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The primary text is "K031803", with the numbers being clearly written. Below this, there's another line of text that reads "10F2", which is smaller in size compared to the first line. The handwriting is somewhat rough, but the characters are still legible. | NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------| | 510(k) CONTACT: | Karla Ham
Sr. Regulatory Affairs Associate | | TRADE NAME: | DePuy Ceramic Femoral Heads | | COMMON NAME: | Ceramic Femoral Ball Prosthesis | | CLASSIFICATION: | 888.3353: Hip joint femoral metal/ceramic/polymer
semi-constrained cemented or nonporous,
uncemented prosthesis;
Class II | | DEVICE PRODUCT CODE: | 87 LZO | 2003 ### DEVICE DESCRIPTION AND INTENDED USE: The DePuy Ceramic Femoral Heads are composed of an alumina composite material and are available in head diameters of 32mm and 36mm sizes with various offset options. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in two variations (11/13 SROM and 12/14 Articul/eze taper options). DePuy Femoral Heads, K011533 The ceramic heads are designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement. ### INDICATIONS FOR USE: DEVICE: The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. - 2. Avascular necrosis of the femoral head. - 3. Acute traumatic fracture of the femoral head or neck. - 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - 5. Certain cases of ankylosis. {1}------------------------------------------------ K031803 2 OF 2 ### BASIS OF SUBSTANTIAL EQUIVALENCE: DePuy considers the Ceramic Femoral Heads to be substantially equivalent to the DePuy Femoral Heads submitted in K011533 based on similarities in design, same material composition, same sterilization and packaging methods, same intended use/indications for use, and similar labels. . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUL 1 2003 Ms. Karla A. Ham Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthpaedic Drive Warsaw. Indiana 46581-0988 Re: K031803 Trade/Device Name: DePuy Ceramic Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: June 10, 2003 Received: June 11, 2003 Dear Ms. Ham: 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 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 (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Karla A. Ham 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, for Mark A. Milliken 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}------------------------------------------------ # 510(k) Number (if known): KO31803 ## Device Name: DePuy Ceramic Femoral Heads ## Indications for Use: The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. - 2. Avascular necrosis of the femoral head. - 3. Acute traumatic fracture of the femoral head or neck. - 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - 5. Certain cases of ankylosis. Concurrence of CDRH, Office of Device Evaluation Mark N. Millkern Division Sign-Off Division of General, Restorative and Neurological Devices 510(k) Number K031803 Prescription Use OR (Per 21 CFR 801.109) Over-The-Counter Use Image /page/4/Picture/16 description: The image shows the number 000003 in a bold, sans-serif font. The numbers are black and stand out against a white background. The image is clear and easy to read, with the numbers evenly spaced and aligned. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K031803](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K031803) **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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