LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER

K101229 · Zimmer, Inc. · LPH · Dec 3, 2010 · Orthopedic

Device Facts

Record IDK101229
Device NameLONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
ApplicantZimmer, Inc.
Product CodeLPH · Orthopedic
Decision DateDec 3, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3358
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs. 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.

Device Story

Modular acetabular cup system for total hip arthroplasty; includes porous-coated shells and highly crosslinked polyethylene elevated liners. Used in primary or revision surgery for hip joint replacement. Fixation achieved with or without bone cement. Line extension adds 42mm OD shells and additional 22mm, 32mm, and 36mm ID elevated liners. 22mm liner features poly-relief ring; 42mm shells modified to exclude screw hole plugs. Device components are implanted by orthopedic surgeons in a clinical/OR setting. Provides mechanical replacement of damaged hip joint surfaces to restore function and mobility.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included wear performance analysis, anatomic fatigue, durability/backside wear, lever-out strength, push-out strength, torque-out strength, and MR compatibility. Results exceeded all acceptance criteria.

Technological Characteristics

Modular acetabular system consisting of porous-coated metal shells and highly crosslinked polyethylene liners. Materials and manufacturing processes are equivalent to predicate devices. Designed for uncemented or cemented fixation. Dimensions include 42mm OD shells and 22mm, 32mm, and 36mm ID liners. Mechanical design includes poly-relief ring on 22mm liners.

Indications for Use

Indicated for primary or revision total hip arthroplasty in skeletally mature individuals with noninflammatory degenerative joint disease (NIDJD), including osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the word "Zimmer" written in a stylized font. Above the word, there is a circular emblem containing a stylized letter "Z" with arrows pointing in opposite directions within the circle. The logo appears to be for the Zimmer company. # K101229 #### Summary of Safety and Effectiveness #### Sponsor: Contact Person: Date: Trade Names: Common Name: Classification Names and References: Predicate Devices: P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131 Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 DEC - 3 20.J Rebecca Brooks Regulatory Affairs Specialist Telephone: 574.371.8033 Fax: 574.372.4605 July 12, 2010 Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Continuum™ Acetabular System Trilogy Integrated Taper (IT) Acetabular System 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. Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer Inc., K091508. cleared September 11, 2009. Longevity® IT Highly Crosslinked Polyethylene Elevated Liners manufactured by Zimmer Inc., K093846, cleared 04 February 2010. {1}------------------------------------------------ ### Kiol229 #### Device Descriptions: #### Intended Use: #### Comparison to Predicate Devices: The Longevity IT Highly Crosslinked Polyethylene Elevated Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs 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. The Longevity IT Highly Crosslinked Polyethylene Elevated Liners and the Continuum and Trilogy IT Acetabular Systems Shells 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. The subject devices are line extensions to the previously cleared predicate systems to add 42mm OD shells and additional 22mm, 32mm, and 36mm ID elevated liners. The subject 32mm and 36mm liners are identical to the previously cleared devices; no changes have been made except for the additional sizes. The subject 22mm liner has been modified to include a poly-relief ring above the scallops. The subject 42mm shells have been modified so that they will not accept the option screw hole plugs. {2}------------------------------------------------ Page 3 July 12, 2010 # K101229 Performance Data (Nonclinical and/or Clinical): Non-Clinical Performance and Conclusions: Non-clinical testing was conducted to demonstrate that the subject device performed as intented and met all acceptance criteria. Specific non-clinical testing that was completed includes: - · Wear Performance Analysis - · Anatomic Fatigue Test - Durability and Backside Wear Analysis - · Lever-Out Strength Test - · Push-Out Strength Test - · Torque-Out Strength Test - · Compatibility in the MR Environment Test Testing was conducted on the subject devices and compared to the predicate systems. The subject devices functioned as intended and the observed test results exceeded all acceptance criteria. Additionally, an evaluation of the device design and geometry was done, which demonstrated that the Zimmer Longevity IT Highly Crosslinked Polyethylene Elevated Liners and the Continuum and Trilogy IT Acetabular Systems Shells meet performance requirements and are as safe and effective as its predicates. This information and testing data forms the basis for a determination of substantial equivalence. Page 3 of 3 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer, Inc. % Ms. Rebecca Brooks Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708 DEC - 3 2010 Re: K101229 Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene Elevated Liners. Continuum™ Acetabular System, Trilogy® Integrated Taper (IT) Acetabular System 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: LPH, JDI, LZO Dated: November 5, 2010 Received: November 8, 2010 Dear Ms. Brooks: 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. {4}------------------------------------------------ Page 2 - Ms. Rebecca Brooks 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 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## KID1229 Indications for Use DEC - 3 2010 #### 510(k) Number (if known): Device Name: Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Continuum™ and Trilogy® IT Acetabular Systems Shells #### 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. DEC - 3 2010 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) Spata for mxn (Dicision Sign Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K101229 Page 1 of 1 28
Innolitics
510(k) Summary
Decision Summary
Classification Order
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