(119 days)
Not Found
No
The summary describes a physical medical device (acetabular liners) and its material properties and performance through non-clinical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is an acetabular liner for total hip arthroplasty, intended to rehabilitate hips damaged by various conditions, which fits the definition of a therapeutic device.
No
Explanation: The device described is an acetabular liner for total hip arthroplasty, which is a medical implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical component (polyethylene liners) intended to mate with acetabular shells, and the performance studies involve mechanical and biological testing of this physical material. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating hip joint damage. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as acetabular liners for total hip arthroplasty, which are physical components implanted in the body.
- Performance Studies: The performance studies focus on mechanical properties, wear resistance, biocompatibility, and toxicity – all relevant to an implantable medical device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to diagnose a condition, which is the core function of an IVD.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
OQG, OQH, OQI, LPH, JDI, LZO
Device Description
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are neutral and elevated acetabular liners which are intended to mate with either the Continuum or Trilogy IT acetabular shells in total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed to determine substantial equivalence.
This included:
- mechanical material characterization (tensile, small punch, Izod Impact, Crack Propagation)
- physical and chemical characterization (Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Lamallae Thickness. Free Radical concentration. Vitamin E Consolidation, Vitamin E Elution and Extraction, Trans-vinylene Index)
- biocompatibility (cvtoxicity, systemic toxicity, bacterial reverse mutation, genotoxicity, peripheral blood micronucleus, intracutaneous reactivity, guinea pig maximization sensitization, muscle implantation, acute systemic toxicity, subchronic toxicity, chronic toxicity, and biological response to wear debris studies)
- wear testing under normal and abrasive conditions
- liner push-out, lever-out, and torque-out resistance
- fit condition assessment
- compatibility in the MR Environment
- locking mechanism durability assessment
- pendulum frictional torque tests under normal and abrasive conditions
- delamination assessment
- anatomic fatigue, and subluxed loading fatigue.
Testing was conducted on the subject devices and compared to legally marketed devices. Evaluations of the device design and geometry were also performed. The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners functioned as intended and met the performance requirements, thus demonstrating that the Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are as safe and effective as the predicate device.
Claims:
- Vivacit-E Vitamin E Highly Crosslinked Polyethylene is formulated with antioxidant protection that prevents oxidation degradation of polyethylene.
- Tensile (ASTM D638), izod impact (ASTM F648, Annex A1), and oxidation index (ASTM F2102) samples were tested in non-aged condition and up to 24 weeks of accelerated aging (ASTM F2003).
- No significant change in tensile or Izod properties and no detectable oxidation (oxidation indices 8.0 minutes after 12 times the standard accelerated aging method.
- Vivacit-E Vitamin E Highly Crosslinked Polyethylene retains mechanical strength after accelerated aging.
- Tensile (ASTM D638) and izod impact (ASTM F648, Annex A1) specimens tested in non-aged condition and up to 24 weeks of accelerated aging (ASTM F2003).
- No statistically significant difference in ultimate tensile strength (p=0.63), elongation (p=0.61), and izod impact (p=0.47) after aging for 12 times the standard accelerated aging method.
- Greater than 96% retention of mechanical properties.
- Vitamin E does not elute from Vivacit-E Vitamin E Highly Crosslinked Polyethylene.
- Exhaustive solvent extractions (boiling hexane, isopropanol) and analysis by FTIR, GC-MS, LC-MS. Residue quantities comparable to non-Vitamin E predicate material.
- Immersion in de-ionized water at 40°C for up to 24 weeks. Vitamin E levels in aqueous solution below detectable limits of UV-Vis. No change in Vitamin E Index or Oxidation Index.
- Pressure-induced leaching study under compressive loading conditions (150 N and 1500 N for one minute). Vitamin E levels under pressure-induced leaching conditions were below the detection limits of fluorescence spectroscopy.
- Vivacit-E Vitamin E Highly Crosslinked Polyethylene resists cracking and oxidation when subjected to environmental stress cracking.
- Cyclic loading in an oxidative environment (0.5 Hz, 10 MPa bending stress at 80℃ in air for 5 weeks). No evidence of cracking and negligible oxidation (~1.5Mc, oxidation indices 8.0 minutes (Claim 2)
Oxidation indices
- Cyclic loading in an oxidative environment (0.5 Hz, 10 MPa bending stress at 80℃ in air for 5 weeks). No evidence of cracking and negligible oxidation (~1.5Mc, oxidation indices 8.0 minutes (Claim 2)
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside a circle, with the word "zimmer" written in lowercase letters below it. The logo is black and white and has a simple, modern design.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Rebecca M. Brooks, Sr. Specialist, Regulatory Affairs Telephone: (574) 371-8033 Fax: (574) 372-4605
May 30, 2012
Vivacit-E® Vitamin E Highly Crosslinked Polyethylene Liners
Total Hip Prosthesis
LPH - Prosthesis, Hip, Semi-constrained, metal/polymer, porous, uncemented; 21 CFR 888.3358
JDI - Prosthesis, Hip, Semi-constrained, metal/polymer, cemented; 21 CFR 888.3350
LZO - Prosthesis, Hip, Semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented; 21 CFR 888.3353
OQG - Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; 21 CFR 888.3358
OOH - Hip. Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; 21 CFR 888.3350
OOI - Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; 21 CFR 888.3353
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Predicate Device:
Device Description:
Intended Use:
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, Inc. (K091508)
Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, Inc. (K093846)
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems and Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, Inc. (K101229)
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems and Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, Inc. (K103662)
Trilogy Acetabular System Longevity Crosslinked Polyethylene Liners manufactured by Zimmer, Inc. (K990135)
El Antioxidant Infused Technology, manufactured by Biomet Manufacturing Corp. (K100048)
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are neutral and elevated acetabular liners which are intended to mate with either the Continuum or Trilogy IT acetabular shells in total hip arthroplasty.
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
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Comparison to Predicate Device:
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are packaged, manufactured, and sterilized using equivalent materials and processes as their predicates. The subject device also has the same intended use as the predicate device.
The subject devices are designed to have the same geometry as the predicate Longevity IT Neutral and Elevated liners.
The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical material characterization (tensile, small punch, Izod Impact, Crack Propagation), physical and chemical characterization (Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Lamallae Thickness. Free Radical concentration. Vitamin E Consolidation, Vitamin E Elution and Extraction, Trans-vinylene Index), biocompatibility (cvtoxicity, systemic toxicity, bacterial reverse mutation, genotoxicity, peripheral blood micronucleus, intracutaneous reactivity, guinea pig maximization sensitization, muscle implantation, acute systemic toxicity, subchronic toxicity, chronic toxicity, and biological response to wear debris studies), wear testing under normal and abrasive conditions, liner push-out, lever-out, and torque-out resistance, fit condition assessment, compatibility in the MR Environment, locking mechanism durability assessment, pendulum frictional torque tests under normal and abrasive conditions, delamination assessment, anatomic fatigue, and subluxed loading fatigue.
Testing was conducted on the subject devices and compared to legally marketed devices. Additionally, evaluations of the device design and geometry were performed. The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners functioned as intended and met the performance requirements,
Performance Data (Nonclinical and/or Clinical):
್ನಿ
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thus demonstrating that the Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are as safe and effective as the predicate device. These analyses and testing data forms the basis for the determination of substantial equivalence.
Claims:
Claim 1:
Vivacit-E Vitamin E Highly Crosslinked Polyethylene is formulated with antioxidant protection that prevents oxidation degradation of polyethylene.
Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/i alpha tocopherol, compression molded, crosslinked with electron beam irradiation) tensile (ASTM D638), izod impact (ASTM F648, Annex A1), and oxidation index (ASTM F2102) samples were tested in the non-aged condition as well as at various intervals up to 24 weeks of accelerated aging according to ASTM F2003. The Vivacit-E Vitamin E HXPE material showed no significant change in tensile or izod properties and no detectable oxidation (oxidation indices induction time (ASTM D3895). Conventional GUR 1050 gamma sterilized samples were used as controls. The oxidative induction time is an assessment of how long it takes a material to oxidize at a high temperature. The standard accelerated aging cycle per ASTM F2003 lasts two weeks and is an aggressive aging method, where oxygen is forced into the material in an attempt to elicit an oxidative response. After aging 12 times the standard method, the Vivacit-E Vitamin E HXPE samples showed no detectable oxidation (oxidation indices 8.0 minutes. After 2 weeks of aging, the conventional GUR 1050 samples showed detectable oxidation with an OI greater than 0.5 and oxidative induction times that were less than 1.0 minute. After 4 weeks aging, the conventional GUR 1050 samples showed oxidation indices greater than 3 and oxidation induction time could not be measured due to the brittleness of the material. The oxidative induction times and oxidation indices after accelerated aging for 24 weeks indicate that the presence of Vitamin E in the Vivacit-E Vitamin E HXPE material actively and continuously prevents oxidation of the material after an extreme oxidative challenge. Bench testing is not necessarily indicative of clinical performance.
Claim 3:
Vivacit-E Vitamin E Highly Crosslinked Polyethylene retains mechanical strength after accelerated aging.
Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/l alpha tocopherol, compression molded, crosslinked with electron beam irradiation) tensile (ASTM D638) and izod impact (ASTM F648, Annex Al) specimens were tested in the non-aged condition and at various aging intervals up to 24 weeks. Accelerated aging was performed according to ASTM F2003 in 100% oxygen at 73 psi and 70°C. The accelerated aging interval according to ASTM F2003 is two weeks and is an aggressive aging mechanism that attempts to force oxygen into the material to elicit an oxidative response. Once the oxidation process reaches a critical level, it can lead to a decline in mechanical properties. Vitamin E HXPE material showed no statistically significant difference in ultimate tensile strength (p=0.63), elongation (p=0.61), and izod impact (p=0.47) after aging for 12 times the standard accelerated aging method. Greater than 96% retention of mechanical properties was seen when comparing non-aged to 24-week aged Vivacit-E Vitamin E HXPE samples, indicating no significant change in properties after aging. Bench testing is not necessarily indicative of clinical performance.
Claim 4:
Vitamin E does not elute from Vivacit-E Vitamin E Highly Crosslinked Polyethylene.
Several exhaustive solvent extractions for up to 3 days were conducted on Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/1 alpha tocopherol, compression molded, crosslinked with electron beam irradiation). Solvents included boiling hexane for three days, and isopropanol at room temperature for three
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days. Fourier transform infrared with detection limits of 100 ppm, gas chromatographymass spectroscopy (GC-MS) with detection limits of 10 ppm and liquid chromatographymass spectroscopy (LC-MS) analysis with detection limits of 10 ppm were used to quantify and identify the extraction residues. The various techniques showed that residue quantities removed from the Vivacit-E material were comparable to a non-Vitamin E predicate material. The FTIR spectral analysis of the residues indicated a strong correlation to aliphatic hydrocarbons and any trace amounts of Vitamin E related peaks were within the noise of the instrument.
The Vitamin E blended into UHMWPE material does not elute from the Vivacit-E Vitamin E HXPE material after a 24 week exposure to an aqueous environment. The Vivacit-E Vitamin E HXPE material was machined into acetabular liners. The Vivacit-E Vitamin E HXPE liners were immersed in 40°C de-ionized water for up to a 24 week exposure time. The liners were removed after immersion for 1, 2, 4, 8, 12 and 24 weeks. A sample of the de-ionized water solution was taken at every time interval and measured by UV-Vis for Vitamin E. The Vitamin E levels in the aqueous solution were below detectable limits of UV-Vis. Vitamin E Index and Oxidation Index (ASTM F 2102) were also measured on the liners at each time interval. All results showed no change in Vitamin E Index or Oxidation Index after a 24 week exposure.
The Vitamin E blended into UHMWPE material does not elute from the Vitamin E HXPE material under compressive loading conditions. The pressure induced leaching study was based on the work presented by Okubo et al. "Confirmation of Pressure-Induced Leaching of Vitamin E from inside of Ultra High Molecular Weight Polyethylene" J. Biomech. Sci. and Eng., 5, 154 (2010). Thin films (100 micron thick) were cut from Vivacit-E Vitamin E HXPE molded blocks. A vertical compressive load was applied to the film with a metal cylindrical rod. The load conditions were set at two different loads of 150 N and 1500 N for one minute which results in 3 MPa and 30 MPa of contact stress. The transfer film was removed with ethanol and analyzed by fluorescence spectroscopy. The Vitamin E levels under the pressure-induced leaching conditions were below the detection limits of fluorescence spectroscopy. Bench testing is not necessarily indicative of clinical performance.
Claim 5:
.
Vivacit-E Vitamin E Highly Crosslinked Polyethylene resists cracking and oxidation when subjected to environmental stress cracking.
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/1 alpha tocopherol, compression molded, crosslinked with electron beam irradiation) material was subjected to cyclic loading in an oxidative environment. A 0.5 Hz, 10 MPa bending stress was applied at 80℃ in an air atmosphere for 5 weeks The Vivacit-E material showed no evidence of cracking and negligible (~1.5Mc). oxidation (oxidation indices - Control Group Average. For the two week interval, 7.0 - 7.0 = 0 and for the twelve week interval, 3.0 - 3.7 = 0 (-. 7). According to the interpretation of the Irritant Ranking Score, a non-irritant is classified as having a range of 0.0 - 2.9. Therefore, with Irritant Ranking Scores of 0.0 and -0.7, Vivacit-E Vitamin E HXPE is classified as a non-irritant. Animal testing is not necessarily indicative of clinical performance.
Claim 11:
Vivacit-E Vitamin E Highly Crosslinked Polyethylene did not elicit systemic toxicity in the mammalian animal model as compared to the control.
Acute systemic toxicity testing was performed per ISO 10993 on healthy adult mice.
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/l alpha tocopherol and compression molded) material was extracted in both a polar and non-polar solvent. The study used a control blank of extraction vehicle without the test article. A single dose of either test article extract or control blank was injected into each animal. Animals were observed for any adverse clinical reactions immediately after injection and then again at 4, 24, 48, and 72 hours after injection. The animals were weighed daily after dosing. There was no mortality or evidence of systemic toxicity from the extracts and the Vivacit-E Vitamin E HXPE extracts met the requirements of the study.
Subchronic systemic toxicity testing was performed per ISO 10993 on healthy adult male and female rats.
A USP high density polyethylene (HDPE) reference standard material was used as the control article to compare to Vivacit-E Vitamin E HXPE. The Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/l alpha tocopherol and compression molded) material and HDPE reference material were surgically implanted in the subcutaneous tissue of the rat. Detailed examinations for clinical signs of disease or abnormality were conducted at pretreatment and weekly thereafter. Body weights of the test subjects were recorded at pretreatment, weekly, and the day prior to termination (prefasted weight) and the day of termination (fasted weight). At 13 weeks, blood samples were taken from each rat for hematology and clinical chemistry analyses. The animals were then euthanized, each implant was excised, and tissue samples were collected, weighed, and preserved. There was no evidence of systemic toxicity from the Vivacit-E Vitamin E HXPE following subcutaneous implantation in the rat for 13 weeks. The local macroscopic tissue reaction was not significant compared to the control article. Macroscopically, the Vivacit-E Vitamin E HXPE was classified as a non-irritant as compared to the control article.
Chronic systemic toxicity testing was performed per ISO 10993 on healthy adult male and female rats.
A USP high density polyethylene (HDPE) reference standard material was used as the control article to compare to Vivacit-E Vitamin E HXPE. The Vivacit-E Vitamin E Highly Crosslinked Polyethylene (UHMWPE resin blended with d/l alpha tocopherol and compression molded) material and HDPE reference material were surgically implanted in
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the subcutaneous tissue of the rat. Detailed examinations for clinical signs of disease or abnormality were conducted at pretreatment and weekly thereafter. Body weights of the test subjects were recorded at pretreatment, weekly, and the day prior to termination (prefasted weight) and the day of termination (fasted weight). At 26 weeks, blood samples were taken from each rat for hematology and clinical chemistry analyses. The animals were then euthanized, each implant was excised, and tissue samples were collected, weighed, and preserved. Macroscopic and microscopic findings showed no evidence of systemic toxicity from the Vivacit-E Vitamin E HXPE following subcutaneous implantation in the rat for 26 weeks. Macroscopic evaluation of the implantation sites showed no irritation in both the Vivacit-E Vitamin E HXPE and control materials. The local macroscopic tissue reaction was not significant compared to the control article. Microscopic evaluation of the subcutaneous tissue from the implantation site was found that the tissue response to Vivacit-E Vitamin E HXPE was comparable to that of the control material. The study classified Vivacit-E Vitamin E HXPE as a non-irritant as compared to the control article. Animal testing is not necessarily indicative of clinical performance.
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Image /page/11/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.
Public Health Service
JUN - 4 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. c/o Rebecca Brook Senior Regulatory Affairs Specialist 1800 West Center Street Warsaw, Indiana 46580
Re: K120370
Trade/Device Name: Vivacit-E Vitamin E Highly Crosslinked Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, OQH, OQI, LPH, JDI, LZO Dated: May 8, 2012 Received: May 9, 2012
Dear Ms. Brook:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
Image /page/11/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
12
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number (if known): ├ (20370
Device Name:
Vivacit-E™ Vitamin E Highly Crosslinked Polyethylene Liners
Indications for Use:
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.P. Pinder Jr.
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K120370
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