(196 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (CLS® Brevius™ Stem with Kinectiv® Technology) seeking clearance from the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria through a study as would be described for a diagnostic AI/ML device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The document focuses on non-clinical (lab) performance testing and does not describe a clinical study of the type that would involve a test set, ground truth experts, or AI/ML performance metrics.
Here's a breakdown based on the information provided in the document and why certain sections are not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a quantitative table format that measures diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests and concludes that the device is "safe and effective and substantially equivalent to the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated through non-clinical (lab) performance testing. |
| Substantial Equivalence | Shown to be similar or identical in intended use, materials, sterility, and performance characteristics to predicate devices (K042249, K081007, K071856, K063251). |
| Mechanical Performance | Passed: Proximal Stem Fatigue Test (including FEA), Distal Stem Fatigue Evaluation, Primary Stability Test, Influence of Version Analysis, Accelerated Corrosion Fatigue Test, Distraction Test, and MR Evaluation. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes non-clinical (lab) performance testing of a physical medical device (femoral stem prosthesis), not a diagnostic AI/ML system. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are engineering/mechanical tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in the context of diagnostic AI/ML is not relevant here. The "ground truth" for non-clinical testing refers to established engineering standards and validated testing methodologies.
4. Adjudication method for the test set
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical implant device, not an AI/ML diagnostic algorithm. Therefore, no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used
- For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering and biomechanical standards and validated test methods against which the device's performance (e.g., fatigue strength, stability) is evaluated. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the AI/ML sense in this document.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device. There is no "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
{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)
12
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Surgical, Orthopedic,
and Restorative Devices
| Page 1 of 1 | |
|---|---|
| ------------- | -- |
| 510(k) Number | K110836 |
|---|---|
| --------------- | --------- |
§ 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.