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Total Knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthrius; failed osteotomies, unicoment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Smith & Nephew, Inc. Cemented Round Patellae with JRNY Pegs are indicated for use with cement and are single use devices.

The subject of this Special 510(k) is the Cemented Round Patellae with JRNY Pegs. The subject Cemented Round Patella with JRNY Pegs are patella components, and a line extension of the GENESIS II Resurfacing Patellae cleared under the GENESIS II Total Knee System premarket notification K951987 (S.E. 8/22/1995). The subject devices were modified by incorporating the identical patella peg and cement pocket geometry from the JOURNEY BCS Resurfacing Patellae, cleared under Smith & Nephew, Inc. High Performance Knee premarket notification K042515 (S.E. 3/14/2005) respectively.

The subject Cemented Round Patellae with JRNY Pegs have a size range of 26, 29, 32, 35, 38, and 41mm with thicknesses range of 7.5mm and 9.0mm. The Cemented Round Patellae with JRNY Pegs are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE), conforming to ASTM F648 (FDA Recognition Number 8-569), and 316 L Stainless Steel, conforming to ASTM F138 (FDA Recognition Number 8-542), identical to the predicate devices GENESIS II Resurfacing Patellae (K951987, S.E. 8/22/1995) and JOURNEY BCS Resurfacing Patellae (K042515, S.E. 3/14/2005).

The provided FDA 510(k) K221939 summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy).

Instead, this document is a 510(k) submission for a medical device (a knee implant component) seeking substantial equivalence to legally marketed predicate devices. The "performance testing" mentioned refers to mechanical testing to ensure the new device performs similarly to the predicate devices, not clinical performance or diagnostic accuracy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. These concepts are not applicable to the type of device and submission described in the provided text.

The "performance testing" section, briefly mentioned, indicates:

• Performance Testing: A review of leveraged mechanical data indicates that the subject Cemented Round Patellae with JRNY Pegs are substantially equivalent to previously cleared predicate devices.
• Evaluated Design Features:
  • Peg Geometry
  • Peg Location
  • Pocket Geometry
• Bacterial Endotoxin Testing: Representative worst-case device met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72.

The conclusion states that the device is substantially equivalent to the predicate devices based on similarities in function, intended use, indications for use, design, and material composition, and mechanical performance. Clinical data was not needed to support safety and effectiveness.

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