(24 days)
Not Found
No
The summary describes a physical medical device (polyethylene liners for hip implants) and its intended use. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on non-clinical testing like wear and range of motion, typical for mechanical implants.
Yes
The device is indicated for rehabilitating hips damaged by various conditions, which is a therapeutic purpose.
No
The device description and intended use indicate it is an implantable medical device (polyethylene liners for total hip arthroplasty), not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical component (polyethylene liners) intended for use in hip arthroplasty, not a software application.
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 replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components (polyethylene liners) used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on wear testing and range of motion, which are relevant to the mechanical function of an implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO
Device Description
The Longevity IT Highly Crosslinked Polyethylene Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available with neutral, elevated, offset, and oblique liner faces in 28, 32, 36, and 40mm articulation diameters.
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 Performance and Conclusions:
Non-clinical testing as well as engineering and risk analyses were performed to demonstrate substantial equivalence of the subject liners to the predicate devices. The specific non-clinical testing and analyses completed include wear testing and range of motion analyses.
The liners were also evaluated in terms of design and geometry to demonstrate that the devices meet performance requirements and are substantially equivalent to their predicates. This information and testing results formed the basis for a determination of substantial equivalence.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K091508, K093846, K101229, K103662
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K123019(1/3)
Image /page/0/Picture/1 description: The image shows a logo with the letter Z inside of a circle. The letter Z is stylized with sharp angles and lines. Below the circle is the word "zimmer" in a sans-serif font. The logo appears to be for a company or brand named Zimmer.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
OCT 22 2012
رار 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
September 27, 2012
Longevity IT Highly Crosslinked Polyethylene Neutral Liners
Longevity IT Highly Crosslinked Polyethylene Elevated Liners
Longevity IT Highly Crosslinked Polyethylene Offset Liners
Longevity IT Highly Crosslinked Polyethylene Oblique 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
ਹੋਰੇ
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Page 2 September 27, 2012
Predicate Device:
Device Description:
Intended Use:
Comparison to Predicate Device:
Continuum and Trilogy IT Acetabular Systems, manufactured by Zimmer, K091508, cleared September 11, 2009
Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K093846, cleared February 4, 2010
Continuum and Trilogy IT Acetabular Systems & Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K101229, cleared December 3, 2010
Continuum and Trilogy IT Acetabular Systems & Longevity IT Highly Crosslinked Polyethylene Elevated, Offset, & Oblique Liners, manufactured by Zimmer, K103662, cleared April 15, 2011
The Longevity IT Highly Crosslinked Polyethylene Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available with neutral, elevated, offset, and oblique liner faces in 28, 32, 36, and 40mm articulation diameters.
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.
No changes are being made to the designs of the subject Longevity IT Liners. The proposed modification is limited to expanding the scope of compatible femoral heads. The Longevity IT Highly Crosslinked Polyethylene Neutral, Elevated,
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Page 3 September 27, 2012
Performance Data (Nonclinical and/or Clinical):
Offset, and Oblique Liners are manufactured, packaged, and sterilized using equivalent materials and processes as their predicates. The subject devices also have the same intended use and performance characteristics as their predicates.
Non-Clinical Performance and Conclusions:
Non-clinical testing as well as engineering and risk analyses were performed to demonstrate substantial equivalence of the subject liners to the predicate devices. The specific non-clinical testing and analyses completed include wear testing and range of motion analyses.
The liners were also evaluated in terms of design and geometry to demonstrate that the devices meet performance requirements and are substantially equivalent to their predicates. This information and testing results formed the basis for a determination of substantial equivalence.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated % Ms. Rebecca M. Brooks Senior Specialist, Regulatory Affairs 1800 West Center Street Warsaw, Indiana 46580
OCT 22 2012
Re: K123019
Trade/Device Name: Longevity® IT Highly Crosslinked Polyethylene neutral, Offset, and Oblique Liners
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained porous-coat-ed uncemented prosthesis
Regulatory Class: Class II Product Code: LPH, JDI, LZO Dated: September 27, 2012 Received: September 28, 2012
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 19 we any nor 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
4
Page 2 - Ms. Rebecca M. Brooks
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 yours,
Mark N. Mellecker
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Longevity IT Highly Crosslinked Polyethylene Neutral, Elevated, Offset, and Oblique 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.
Asb
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
8123019 510(k) Number
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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