(161 days)
Total knee components are indicated for:
-
Rheumatoid arthritis.
-
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.
The subject Porous Patella is designed to be implanted with or without the use of bone cement for a total knee replacement. The Porous Patella will be made of UHMWPE and Ti-6Al-4V. The metal bone contacting surface and 3 pegs will be made from Ti-6Al-4V, which will be porous, and the bearing surface will be UHMWPE. The bone contacting porous structure will be made of CONCELOC, a material formerly cleared as part of the REDAPT CONCELOC Fully Porous Cup, K1813266. The UHMWPE will be direct compression molded on to the Ti-6AI-4V metal back. The subject Porous Patella will be designed as oval and round resurfacing patellae. The subject device will be press fit into the bone with 3 pegs for initial fixation and provided in various sizes, 26mm-41mm. As a reference, the bearing surface profile of this subject Porous Patella is identical to the Smith & Nephew Genesis II Patella, which was cleared under K042515.
The subject Porous Tibia Baseplate is designed to be implanted with or without the use of bone cement. The Porous Tibia Baseplate is made of Ti-6AI-4V and includes a porous ingrowth surface on the distal face of the implant. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's Journey cemented tibial implant cleared under K121443. The distal side of the implant has a central stem, two large posterior-directed fins, and two smaller anterior-directed fins. There are also two tibial lugs on the anterior half of the implant, one on each of the medial and lateral side of the stem. The subject device includes the same stem length for all sizes, though the fin sizes and locations of the lugs vary between sizes. The subject tibia baseplate includes multiple sizes in both left and right hand versions.
The provided document is a 510(k) premarket notification for a medical device (Porous Patella and Porous Tibia Baseplate). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or developing complex AI algorithms. Therefore, much of the information requested about AI performance, human reader studies, and ground truth establishment in typical AI/ML medical device submissions is not applicable to this document.
Here's a breakdown of the available information based on your request:
1. Table of acceptance criteria and the reported device performance:
The document describes performance testing used to establish substantial equivalence. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated through testing against predicate) |
|---|---|
| Porous Patella: | Porous Patella: |
| - Mechanical performance equivalent to predicate devices (e.g., in tensile strength, shear strength, fatigue, etc.) | - Tensile Strength |
| - Material properties (e.g., pore diameter, coating thickness, roughness, porosity) comparable to predicate. | - Shear Strength |
| - UHMWPE mechanical testing consistent with standard. | - Peg Shear Strength |
| - Nitric passivation of UHMWPE. | - Shear Fatigue Durability testing |
| - Contact Area and Contact Stresses (comparison to predicate) | |
| - Resistance to Subluxation (comparison to predicate) | |
| - Surface Pore Diameter (comparison to predicate) | |
| - Mean Coating Thickness (comparison to predicate) | |
| - Roughness (comparison to predicate) | |
| - Tensile Properties | |
| - Impact Resistance | |
| - Average Porosity (comparison to predicate) | |
| - Mean Void Intercept Length (comparison to predicate) | |
| - Mechanical Testing of Compression molded Polyethylene | |
| - Nitric Passivation of UHMWPE | |
| Porous Tibia Baseplate: | Porous Tibia Baseplate: |
| - Mechanical performance equivalent to predicate devices (e.g., in finite element analysis, fatigue, adhesion). | - Finite Element Analysis for Worst Case Fatigue |
| - Material properties (e.g., chemical composition, pore diameter, coating thickness, porosity, microstructure, roughness). | - Unsupported Baseplate Fatigue |
| - Shear strength of pegs and coating/substrate attachment. | - Cement Adhesion |
| - Tensile attachment strength and substrate properties. | - Intra-plate variability |
| - Abrasion resistance. | - Chemical composition of substrate |
| - Surface Pore Diameter (comparison to predicate) | |
| - Mean coating thickness (comparison to predicate) | |
| - Mean void intercept length (MVIL) (comparison to predicate) | |
| - Average porosity (mean volume percent voids) (comparison to predicate) | |
| - Weld diameter or area | |
| - Microstructure | |
| - Roughness (comparison to predicate) | |
| - Static Shear Strength - baseplate pegs | |
| - Shear fatigue Strength - baseplate pegs | |
| - Shear fatigue - baseplate porous coating/substrate | |
| - Tensile attachment Strength | |
| - Tensile properties of substrate | |
| - Inter-plate variability | |
| - Abrasion Resistance | |
| Sterility: | Sterility: |
| - Meet acceptable endotoxin limits per FDA Guidance. | - Bacterial endotoxin testing completed and met acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify a "test set" in the context of clinical data or AI model evaluation. The tests performed are benchtop mechanical and material characterization tests. The specific number of samples for each test (e.g., number of patellae for tensile strength, number of tibia baseplates for fatigue testing) is not provided in this summary.
- Data provenance: Not applicable in the sense of patient data. The provenance for the benchtop tests would be internal laboratory testing by Smith & Nephew.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The device is a mechanical implant, and its performance is evaluated through engineering and material science benchtop tests, not clinical expert review or AI ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for clinical trials or expert review of diagnostic results. This submission relies on benchtop engineering tests.
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:
- This is not applicable. This is a submission for a mechanical implant, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering and material science standards and benchmarks, generally derived from similar predicate devices and relevant industry standards (e.g., for mechanical properties, material composition, and manufacturing processes).
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this device.
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October 1, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".
Smith & Nephew, Inc. Brad Sheals Senior Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K211221
Trade/Device Name: Porous Patella and Porous Tibia Baseplate Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 9, 2021 Received: September 10, 2021
Dear Brad Sheals:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K211221
Device Name Porous Patella and Porous Tibia Baseplate
Indications for Use (Describe) Total knee components are indicated for:
-
Rheumatoid arthritis.
-
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Smith+Nephew. The text is in a sans-serif font and is colored orange. The plus sign in the middle of the name is slightly smaller than the other letters.
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Date of Summary: | September 09, 2021 |
| Contact Person and Address: | Mr. Brad Sheals, MSSenior Regulatory Affairs ManagerMobile: (901) 288-7141 |
| Secondary Contact Person andAddress: | Mrs. Michelle Huettner, RACRegulatory Affairs DirectorMobile: (765) 426-6070 |
| Name of Device: | Porous Patella and Porous Tibia Baseplate |
| Common Name: | Patella and Tibia Baseplate |
| Device Classification Name andReference: | 21 CFR 888.3565 - Knee joint patellofemorotibialmetal/polymer porous-coated uncementedprosthesis (Primary classification) |
| 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MBH and JWH |
| Predicate Device: | Porous Patella Predicate -Triathlon® Titanium® Metal-Backed PatellaK132624 (Primary predicate)GENESIS II Total Knee System- Patella K951987 |
| Reference predicate devices include-ZUK™ UHMWPE Articular Surface K033363REDAPT CONCELOC Fully Porous Cup K181366 | |
| Porous Tibia Baseplate Predicate -LEGION Porous + HA Tibial Baseplates K100897(Primary predicate)JOURNEY Non-Porous Tibia BaseplatesK042515Genesis II Porous Tibial Trays and Revision KneeSystem K053274 |
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Image /page/4/Picture/1 description: The image contains the logo for Smith+Nephew. The logo is in orange font and is on a white background. The plus sign is between the two words and is slightly raised.
Device Description
The subject Porous Patella is designed to be implanted with or without the use of bone cement for a total knee replacement. The Porous Patella will be made of UHMWPE and Ti-6Al-4V. The metal bone contacting surface and 3 pegs will be made from Ti-6Al-4V, which will be porous, and the bearing surface will be UHMWPE. The bone contacting porous structure will be made of CONCELOC, a material formerly cleared as part of the REDAPT CONCELOC Fully Porous Cup, K1813266. The UHMWPE will be direct compression molded on to the Ti-6AI-4V metal back. The subject Porous Patella will be designed as oval and round resurfacing patellae. The subject device will be press fit into the bone with 3 pegs for initial fixation and provided in various sizes, 26mm-41mm. As a reference, the bearing surface profile of this subject Porous Patella is identical to the Smith & Nephew Genesis II Patella, which was cleared under K042515.
The subject Porous Tibia Baseplate is designed to be implanted with or without the use of bone cement. The Porous Tibia Baseplate is made of Ti-6AI-4V and includes a porous ingrowth surface on the distal face of the implant. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's Journey cemented tibial implant cleared under K121443. The distal side of the implant has a central stem, two large posterior-directed fins, and two smaller anterior-directed fins. There are also two tibial lugs on the anterior half of the implant, one on each of the medial and lateral side of the stem. The subject device includes the same stem length for all sizes, though the fin sizes and locations of the lugs vary between sizes. The subject tibia baseplate includes multiple sizes in both left and right hand versions.
Indication for Use:
Total knee components are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.
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Image /page/5/Picture/1 description: The image shows the logo for Smith+Nephew. The text is in orange and is on a white background. The plus sign is slightly raised and smaller than the other letters.
Technological Characteristics
A review of the technological characteristics indicates that the subject Porous Patella and the subject Porous Tibia Baseplate are equivalent to existing, legally marketed predicate devices with regards to mechanical performance (e.g. Mechanical testing and assessments) and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and equivalent material composition, and very similar in overall design to the predicate devices listed in the following tables, 5.1 and 5.2.
Table 5.1: Substantially Equivalent Predicate(s)- Porous Patella
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew(Primary Predicate) | GENESIS II Total Knee System-Patella | K951987 | 08/22/1995 |
| StrykerOrthopaedics | Triathlon® Tritanium® Metal-Backed Patella | K132624 | 11/26/2013 |
Reference porous patella predicate devices within this submission included the ZUK™ UHMWPE Articular Surface (K033363, S.E.01/16/2004) and REDAPT CONCELOC Fully Porous Cup (K181366, S.E. 09/24/2018).
Table 5.2: Substantially Equivalent Predicate(s)- Porous Tibia Baseplate
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew(Primary Predicate) | GENESIS POROUS TIBIAL TRAYS& REVISION KNEE SYSTEM | K953274 | 02/05/1996 |
| Smith & Nephew | LEGION Porous + HA TibialBaseplates | K100897 | 05/13/2010 |
| Smith & Nephew | Journey Non-Porous TibiaBaseplate | K042515 | 03/14/2005 |
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Image /page/6/Picture/1 description: The image shows the logo for Smith+Nephew. The text is in a sans-serif font and is colored orange. The plus sign is slightly smaller than the other letters.
Performance Testing:
To further support a determination of substantial equivalence, Mechanical testing and/or assessments was utilized. A review of the leveraged data indicates that the subject Porous Patella and Porous Tibia Baseplate are substantially equivalent to one or more of the previously cleared predicate devices listed in Tables 5.1 and 5.2 above. The following performance testing in Table 5.3 was used as a basis for the determination of substantial equivalence.
| Porous Patella | Porous Tibia Baseplate |
|---|---|
| Tensile Strength Shear Strength Peg Shear Strength Shear Fatigue Durability testing Contact Area and Contact Stresses Resistance to Subluxation Surface Pore Diameter Mean Coating Thickness Roughness Tensile Properties Impact Resistance Average Porosity Mean Void Intercept Length Mechanical Testing of Compression molded Polyethylene Nitric Passivation of UHMWPE | Finite Element Analysis for Worst Case Fatigue Unsupported Baseplate Fatigue Cement Adhesion Intra-plate variability Chemical composition of substrate Surface Pore Diameter Mean coating thickness Mean void intercept length (MVIL) Average porosity (mean volume percent voids) Weld diameter or area Microstructure Roughness Static Shear Strength- baseplate pegs Shear fatigue Strength- baseplate pegs Shear fatigue- baseplate porous coating/substrate Tensile attachment Strength Tensile properties of substrate Inter-plate variability Abrasion Resistance |
Table 5.3: Benchtop Performance Testing Strategy
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Porous Patella and Porous Tibia Baseplate. Based on the similarities to the predicate devices, the subject devices are substantially equivalent to the commercially available cleared predicate devices listed above.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.