(133 days)
The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is indicated for cemented application only.
The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement
This 510(k) submission (K061340) for the 23 mm Single-Peg Patella Component does not include any clinical study data or acceptance criteria related to device performance in a clinical setting.
The submission explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." This means there was no study performed to evaluate the device's performance against specific acceptance criteria in humans.
Instead, the substantial equivalence was based on non-clinical testing and comparison to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided text, while also highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: No specific clinical acceptance criteria or performance metrics (e.g., patient outcomes, complication rates, functional scores) were provided. | Clinical Performance: No clinical performance data was reported or evaluated in this submission. The device's safety and effectiveness were inferred through substantial equivalence to predicate devices and non-clinical testing. |
| Non-Clinical Performance: Not explicitly detailed in specific metrics (e.g., wear rate, fatigue strength). Stated broadly as "functional within its intended use." | Non-Clinical Performance: "The results indicated that the device was functional within its intended use." This suggests mechanical and material testing met internal or industry standards relevant to the device type, but specific thresholds are not provided in this summary. |
| Material/Design/Sizing: Implied acceptance is similarity to predicate devices. | Material/Design/Sizing: "The technological characteristics (material, design, sizing, and indications) of the 23 mm Single-Peg Patella Components are similar or identical to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set data was provided. Non-clinical testing would have involved specific sample sizes for mechanical tests, but these details are not present in the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set and thus no ground truth established by experts in this context.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical implant, not an AI software, and no clinical comparative effectiveness study was conducted for this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in a clinical sense. For non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and biomechanical principles, evaluated through laboratory testing.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" in the context of an algorithm or machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:
The 510(k) submission for the 23 mm Single-Peg Patella Component relies entirely on non-clinical laboratory testing and substantial equivalence to predicate devices to demonstrate safety and effectiveness.
- Non-Clinical Testing: The summary broadly states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This type of testing would typically include mechanical, fatigue, wear, and possibly material characterization tests to ensure the device's physical properties and performance meet design specifications and relevant industry standards. However, specific details about the tests performed, the acceptance criteria for those tests, or the results are not provided in this 510(k) summary.
- Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is its "substantial equivalence" to three legally marketed predicate devices: Vanquard™ Patella (K040770), Ultra High Molecular Weight Components Knees (K921182), and AGC Revision Knee Prosthesis (K912245). The applicant argues that the "technological characteristics (material, design, sizing, and indications)" are "similar or identical" to these predicates. The FDA concurred with this assessment, allowing the device to be marketed.
In essence, the device was deemed to meet acceptance criteria not through a clinical study demonstrating its performance in patients, but by showing it is functionally similar to already approved devices and performs acceptably in laboratory tests.
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510(k) Summary
| Prepared: | September 14, 2006 | SEP 25 2006 |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587 | |
| Contact Person: | Lester F. Padilla | |
| Proprietary Name: | 23 mm Single-Peg Patella Component | |
| Common Name: | Patella Component | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis (21 CFR 888.3560) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
-
- Vanquard™ Patella (K040770)
-
- Ultra High Molecular Weight Components Knees (K921182)
-
- AGC Revision Knee Prosthesis (K912245)
Device Description: The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement
Intended Use: The 23 mm Single Peg Patella intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically: (1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; (2) Correction of varus, valgus or posttraumatic deformity; (3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is indicated for cemented application only.
Summary of Technologies: The technological characteristics (material, design, sizing, and indications) of the 23 mm Single-Peg Patella Components are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Lester F. Padilla, RAC Regulatory Affairs Associate 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
SEP 2 5 2006
Re: K061340 Trade/Device Name: 23 mm Single-Pêg Patella Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: September 14, 2006 Received: September 18, 2006
Dear Mr. Padilla:
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.
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Page 2 - Mr. Lester F. Padilla
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 (24 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Constimer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
f
Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K061340 |
|---|---|
| --------------------------- | --------- |
Device Name: 23 mm Single-Peg Patella Component
Indications for Use:
The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is indicated for cemented application only.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ NO (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)
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Pothin
(Division Sign-Off) Division of General, Restoral A and Neurological Devices
510(k) Number kccj24c
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.