(196 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its intended use and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device, a femoral stem for hip replacement, is intended to replace parts of the human body and addresses medical conditions like degenerative joint disease, fractures, and failed previous surgeries, which aligns with the definition of a therapeutic device.
No
Explanation: The device described is a femoral stem for hip replacement surgery. Its intended use is to replace part of the femur due to conditions like osteoarthritis or fractures, which is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly describes a physical, modular femoral stem made of titanium alloy, which is a hardware component. The performance studies also focus on non-clinical testing of the physical device's properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a femoral stem designed for total or hemi-hip replacement surgery. This is an implantable medical device used within the body during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological samples.
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
Total hip replacement for patients with:
- Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Femoral neck fractures.
- . Failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty. .
Hemi-hip replacement for patients with:
- Femoral neck fractures. .
This femoral stem is for cementless use only.
Product codes
LZO, LPH, KWA, JDL, LWJ, KWZ, JDI
Device Description
The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur; hip joint
Indicated Patient Age Range
Not Found
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: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Proximal Stem Fatigue Test (including Finite Element Analysis to determine the worst case device for this test), Distal Stem Fatigue Evaluation, Primary Stability Test, Influence of Version Analysis, Accelerated Corrosion Fatigue Test, Distraction Test, and MR Evaluation.
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)
K042249, K081007, K071856, K063251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K110836 (pg. i of 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, with each letter outlined.
OCT - 7 2011
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
Zimmer, Inc. SulzerAllee 8 CH-8404 Winterthur, Switzerland
Daniel J. Williman Specialist, Regulatory Affairs Telephone: 574-371-8065 Fax: (574) 372-4605
September 28, 2011
CLS® Brevius™ Stem with Kinectiv® Technology
LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
KWA - Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
JDL - prosthesis, hip, semi-constrained (metal cemented acetabular component)
LWJ - Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer
JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented
21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Sponsor:
Contact Person:
Date:
Trade Name:
Product Code / Device:
Regulation Number / Description:
1
K110836 (pg. 2 of 3)
21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
21 CFR § 888.3330 - Hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis
21 CFR 888.3320 - Hip joint metal/metal semiconstrained, with a cemented acetabular component, prosthesis
21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
21 CFR § 888.3310 - Hip joint metal/polymer constrained, cemented or uncemented prosthesis
21 CFR § 888.3350 - Hip joint metal polymer, semi-constrained cemented prosthesis
CLSTM Spotorno™ Femoral Stem, manufactured by Zimmer Austin, Inc., K042249, cleared September 15, 2004
Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System, manufactured by Zimmer Inc., K081007, cleared May 6, 2008
Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System, manufactured by Zimmer Inc., K071856, cleared July 30, 2007
Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology, manufactured by Zimmer Inc. K063251, cleared January 24, 2007
The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction
Device Description:
Predicate Device:
2
K110836 (pg. 3 of 3)
instrumentation.
Total hip replacement for patients with:
- · Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- · Femoral neck fractures.
- · Failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of previously failed hip arthroplasty.
Hemi-hip replacement for patients with:
- · Femoral neck fractures.
This femoral stem is for cementless use only.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The CLS Brevius system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s).
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Proximal Stem Fatigue Test (including Finite Element Analysis to determine the worst case device for this test), Distal Stem Fatigue Evaluation, Primary Stability Test, Influence of Version Analysis, Accelerated Corrosion Fatigue Test, Distraction Test, and MR Evaluation.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Intended Use:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right, and the text is arranged around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Daniel Williman Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw. Indiana 46581-0708
OCT - 7 2011
Re: K110836
Trade/Device Name: CLS® Brevius™ Stem with Kinectiv® Technology Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acctabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LZO, LPH, LWJ, KWZ, JDI Dated: September 28, 2011 Received: September 29, 2011
Dear Mr. Williman:
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 net 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 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 (2 i CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 – Mr. Daniel Williman
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.html 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/Reportal/roblem/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,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthoped 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:
CLS® Brevius™ Stem with Kinectiv® Technology
Indications for Use:
Total hip replacement for patients with:
- Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Femoral neck fractures.
- . Failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty. .
Hemi-hip replacement for patients with:
- Femoral neck fractures. .
This femoral stem is for cementless use only.
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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