← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K051737 # MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE (K051737) _Howmedica Osteonics Corp. · LZO · Jul 19, 2005 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K051737 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Jul 19, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The V40 "/C-Taper Adapter Sleeve is intended to allow either a Howmedica Osteonics C-Taper Alumina Head or a Howmedica Osteonics C-Taper Biolox® Delta Ceramic Femoral Head to mate with a Howmedica Osteonics femoral stem with a V40" taper. The V40" /C-Taper Adapter Sleeve is a single-use device. ## Device Story Tapered sleeve component; female V-40 taper locks with Howmedica Osteonics femoral stem; male exterior taper locks with C-Taper Alumina or Biolox Delta Ceramic Femoral Heads. Used in orthopedic surgery for total or bipolar hip replacement. Device facilitates modularity between femoral stems and ceramic heads. Single-use. Surgeon-operated during hip arthroplasty. Benefits patient by enabling use of specific ceramic bearing surfaces in hip reconstruction. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Tapered sleeve; female V-40 internal taper; male external C-Taper. Material: Zirconia toughened Alumina (for ceramic heads). Single-use. Mechanical locking mechanism. ## 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. ## 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}------------------------------------------------ Line Extension to the V40" /C-Taper Adaptor Sleeve JUL 19 2005 K051737 p1/2 Special 510(k) Premarket Notification # 510(k) Summary of Safety and Effectiveness Line Extension to the V-40™/C-Taper Adapter Sleeve | Proprietary Name: | V-40™/C-Taper Adapter Sleeve | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | V40™/C-Taper Adapter Sleeve | | Proposed Regulatory Class: | Class II | | Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis, 21 CFR §888.3353. | | Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented | | For Information contact: | Karen Ariemma, Senior Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Telephone: (201) 831-5718
Fax: (201) 831-6038
Email: karen.ariemma@stryker.com | | Date Summary Prepared: | June 27, 2005 | # Device Description The subject V-40" /C-Taper Adapter Sleeve is a tapered sleeve component with a female V-40" taper to provide locking with a Howmedica Osteonics femoral stem with a V-40 * taper. In addition, the sleeve has a tapered male exterior surface that provides locking with Howmedica Osteonics C-Taper Alumina Ceramic Heads. ## Device Modification This submission adds the use of a C-Taper Biolox® Delta Ceramic Femoral Head with the V-40"/C-Taper Adapter Sleeve. ## Intended Use The V40 "/C-Taper Adapter Sleeve is intended to allow either a Howmedica Osteonics C-Taper {1}------------------------------------------------ K051737 p²/₂ Special 510(k) Premarket Notification Alumina Head or a Howmedica Osteonics C-Taper Biolox® Delta Ceramic Femoral Head to mate with a Howmedica Osteonics femoral stem with a V40" taper. The V40" /C-Taper Adapter Sleeve is a single-use device. #### Indications for Use #### For Use as a Total Hip Replacement: - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis. - Revision of previous cup arthroplasty or other procedures. . - Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results. #### For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions. . - . Aseptic necrosis of the femoral head. - Osteo- rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion. #### Other Considerations: - Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum. - Salvage of failed total hip arthroplasty. . #### Substantial Equivalence The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical. The material of the subject V40"/C-Taper Adapter Sleeve remains unchanged. The subject ceramic femoral heads are fabricated from Zirconia toughened Alumina. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA JUL 1 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07432 \$\frac{1}{2}\$ Re: K051737 Trade/Device Name: V40™/C-Taper Sleeve 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 27, 2005 Received: June 28, 2005 Dear Ms. Ariemma: 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. Karen Ariemma This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will and in yours of substantial equivalence of your device to a legally premaired predicated on "The station 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 if you desire specific arrant at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of County of County of Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on Jour Corsumer 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, E. A. Th Miriam C. Provost, Ph.D Acting 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): ____________________________________________________________________________________________________________________________________________________ Device Name: V40"/C-Taper Adapter Sleeve Indications For Use: The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' adapter sleeves is as follows: ・。 ## For Use as a Total Hip Replacement - Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis. - Revision of previous cup arthroplasty or other procedures. . - Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results. ## For Use as a Bipolar Hip Replacement - Femoral head/neck fractures or non-unions. . - Aseptic necrosis of the femoral head. . - Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion. ## Other Considerations: - Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum. - Salvage of failed total hip arthroplasty. . Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) ﻨﺘﺸﺘﻬﺎ ﺗﺘﺮﺑ ﺍﻟﺘﻘ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | Page 1 of 1 | |--|-------------| | | | | | | | | | | | | Division Sign-Off Division of General Restorative K051737 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K051737](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K051737) **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