(119 days)
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
The Distal Femoral Spacer is a poly(methyl methacrylate) [PMMA] cement spacer designed to help adjust extension gaps and maintain a uniform cement mantle when used with the femoral component of a cemented total knee prosthesis. It is used in pairs; each Distal Femeral Spacer fits over one of the femoral posts. This creates a defined space between the femoral component and the prepared bone, helping maintain a uniform cement mantle. The Distal Femoral Spacers themselves are then incorporated into the cement mantle by the polymerizing bone cement. The Distal Femoral Spacer is available in 2mm and 4mm thicknesses.
The provided document K050105 is a 510(k) summary for the NexGen® Complete Knee Solution Distal Femoral Spacers. It describes a medical device, its intended use, and its comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria.
The document explicitly states:
- "Non-clinical performance testing was not required for this device."
- "Clinical data and conclusions were not needed for this device."
This means that the device's clearance was based on substantial equivalence to a predicate device, and not on the results of a performance study with acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (No acceptance criteria or performance study data is presented in this 510(k) summary.) | (No reported device performance from a specific study is presented.) |
Explanation: The 510(k) summary states that "Non-clinical performance testing was not required for this device" and "Clinical data and conclusions were not needed for this device." The clearance was based on substantial equivalence to a predicate device (ZCA® All-Poly Acetabular Cup, Snap-In (PMMA spacer), K030153). Therefore, there are no specific acceptance criteria or performance results from a study to report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable. No test set was used for a performance study.
- Data Provenance: Not applicable. No performance study data was generated or analyzed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. No ground truth was established for a test set, as no performance study was conducted.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No test set or adjudication was used.
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
- MRMC Study: No. This is a physical medical device (knee spacers), not an AI/software device involving human readers or AI assistance.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not a software algorithm; it is a physical implantable device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No performance study requiring a gold standard or ground truth was conducted for this 510(k) submission.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
{0}------------------------------------------------
MAY 1 7 2005
Summary of Safety and Effectiveness
:
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon HipsherSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | January 17, 2005 |
| Trade Name: | NexGen® Complete Knee Solution Distal FemoralSpacers |
| Common Name: | Total knee prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis21 CFR § 888.3560 |
| Predicate Device: | ZCA® All-Poly Acetabular Cup, Snap-In (PMMAspacer) manufactured by Zimmer, Inc., K030153,cleared April 1, 2003. |
| Device Description: | The Distal Femoral Spacer is a poly(methylmethacrylate) [PMMA] cement spacer designed tohelp adjust extension gaps and maintain a uniformcement mantle when used with the femoralcomponent of a cemented total knee prosthesis. It isused in pairs; each Distal Femoral Spacer fits overone of the femoral posts. This creates a definedspace between the femoral component and theprepared bone, helping maintain a uniform cementmantle. The Distal Femoral Spacers themselves arethen incorporated into the cement mantle by thepolymerizing bone cement. The Distal FemoralSpacer is available in 2mm and 4mm thicknesses. |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to: |
:
{1}------------------------------------------------
50105
.
Rheumatoid arthritis, osteoarthritis, traumatic
2/2
arthritis, polyarthritis. Collagen disorders and/or avascular necrosis of . the femoral condyle. Post-traumatic loss of joint configuration, . particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus or flexion deformities. . The salvage of previously failed surgical . attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only. The Distal Femoral Spacers are substantially Comparison to Predicate Device: equivalent to the predicate PMMA spacer in that both are manufactured from the same material and are intended to help maintain a uniform cement mantle. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-clinical performance testing was not required for this device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Zimmer Incorporated 345 East Main Street Warsaw, Indiana 46580
Re: K050105
Trade/Device Name: Nex Gen® Complete Knee Solution Distal Femoral Spacers Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial metal/ polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 13, 2005 Received: April 14, 2005
Dear Mr. Hipsher:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{3}------------------------------------------------
Page 2- Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow your to organization of substantial equivalence of your device to a legally premarket notification: "The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific arrivate - J at (240) 276-0120 . Also, please note the regulation entitled, coniact the Office of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Rurle
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution Distal Femoral Spacers
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. ।
- Collagen disorders and/or avascular necrosis of the femoral condyle. ﺍ
- Conagen disorders and or trussenaration, particularly when there is patellofemoral l erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. ।
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
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)
Stupt Purde
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
Page 1 of 1
KOSDIOS 510(k) Number ...
N/A