(90 days)
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.
The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.
The GCK unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
This submission describes design modifications to the previously cleared GCK unicompartmental femoral components and all polyethylene unicompartmental tibial components.
This document describes the 510(k) summary for the DePuy GCK Femoral and Tibial Components, focusing on design modifications to previously cleared components.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (DePuy GCK, DePuy Sigma Unicompartmental Knee) | The modified GCK unicompartmental femoral and all polyethylene unicompartmental tibial components have the same indications and intended use, the same articulating geometry, the same sizes, and are manufactured from the same materials as the previously cleared GCK components. |
| Mechanical Integrity/Performance | Finite Element Analysis (FEA) performed to demonstrate substantial equivalence to predicate devices and other clinically successful designs. Specific results or quantitative acceptance criteria for FEA are not provided in this summary. |
| Intended Use/Indications | Deemed to have the "same indications and intended use" as predicate devices. Intended to provide increased patient mobility and reduced pain by replacing damaged knee joint articulation. Indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis, or a history of gout or pseudogout. All GCK components are for CEMENTED USE ONLY. |
| Material Equivalence | Manufactured from the "same materials" as the previously cleared GCK unicompartmental femoral and all polyethylene unicompartmental tibial components. |
| Geometric Equivalence (Articulating Geometry & Sizes) | Have the "same articulating geometry" and the "same sizes" as the previously cleared GCK components. |
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This submission relies on non-clinical testing (Finite Element Analysis) for substantial equivalence, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The Finite Element Analysis would be computational data generated based on design specifications and material properties.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. As no clinical test set was used, no experts were involved in establishing ground truth for such a set. Substantial equivalence was primarily based on engineering analysis and comparison to predicate devices, which would have been reviewed by the FDA.
-
Adjudication Method for the Test Set:
- Not applicable, as no clinical test set was evaluated.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not necessary to determine substantial equivalence."
-
Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical knee implant, not an algorithm or AI system. Its performance is assessed through engineering analysis (FEA) and equivalence to established predicate devices.
-
Type of Ground Truth Used:
- Engineering-based equivalence: The "ground truth" for this submission is established through demonstrating that the modified components are substantially equivalent to previously cleared and clinically successful predicate devices, based on their design, materials, intended use, and simulated mechanical performance (Finite Element Analysis). There is no "ground truth" in the sense of clinical outcomes or pathology for this specific submission, as clinical testing was not conducted.
-
Sample Size for the Training Set:
- Not applicable, as this is a physical medical device and not an AI or algorithm that requires a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable.
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| 3. 510(K) SUMMARY | |
|---|---|
| Applicant / Sponsor: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration No.: 1818910JUN 26 2007 |
| Contact Person: | Nancy FriddleTeam Leader, Regulatory AffairsTel: (574) 371-4923Fax: (574) 371-4987 |
| Proprietary Name: | DePuy GCK Femoral and Tibial Components |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification Name: | 21 CFR 888.3560: Knee joint patellofemorotibial,polymer/metal/polymer semi-constrained cementprosthesis, Class II |
| Product Codes: | NPJ, HRY |
| SubstantiallyEquivalent Devices: | • DePuy GCK (K061648) |
| • DePuy Sigma Unicompartmental Knee, submitted as theJ&J PFC Unicondylar Knee System (K910968) |
Device Description:
The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or latcral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patcllofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.
The GCK unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
This submission describes design modifications to the previously cleared GCK unicompartmental femoral components and all polyethylene unicompartmental tibial components.
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Intended Use / Indications:
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USF ONLY.
Summary of Technologies/Substantial Equivalence:
The modified GCK unicompartmental femoral and all polyethylene unicompartmental tibial components have the same indications and intended use, the same articulating geometry, the same sizes and are manufactured from the same materials as the previously cleared GCK unicompartmental femoral and all polyethylene unicompartmental tibial components.
Non-Clinical Testing:
Finite Element Analysis was performed to demonstrate the substantial equivalence of the modified GCK unicompartmental femoral components to the predicate Sigma Unicompartmental femoral components and other clinically successful designs.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the subject modified GCK components and the predicate GCK components.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 2007
DePuy Orthopaedic, Inc. % Ms. Nancy Friddle Team Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K070849
Trade/Device Name: DePuy GCK Femoral and Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: NPJ, HRY Dated: March 16, 2007 Received: March 28, 2007
Dear Ms. Friddle:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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
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Page 2 - Ms. Nancy Friddle
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.
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 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 Consumer 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 vours.
sincerely yours,
Mark H. Wilkerson
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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2. INDICATIONS FOR USE
510(k) Number (if known): _ KO70849
Device Name: DePuy GCK Femoral and Tibial Components
Indications for Use:
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint atticulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral atticular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Mark Honculada of CDRH, Office of Device Evaluation (ODE)
070840
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Page 1 of 1
00000006
§ 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.