(161 days)
No
The 510(k) summary describes a knee implant device made of standard materials and design principles, with no mention of AI or ML in its intended use, device description, or performance studies.
Yes.
The device is a total knee replacement component, which is used to treat conditions like arthritis, aiming to alleviate pain and improve joint function, thus providing therapeutic benefit.
No
Explanation: The device described is a total knee component, specifically a porous patella and porous tibia baseplate, intended for implantation. It is a prosthetic device for reconstructive surgery and does not perform diagnostic functions.
No
The device description clearly details physical components made of UHMWPE and Ti-6Al-4V, designed for surgical implantation in the knee. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a total knee component, specifically a Porous Patella and a Porous Tibia Baseplate. These are implants designed to be surgically placed within the human body to replace damaged knee joints.
- Intended Use: The intended use describes the conditions for which the total knee components are indicated, all of which relate to issues with the knee joint itself (arthritis, failed surgeries).
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 testing included: 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.
Porous Tibia Baseplate testing included: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Porous Patella Predicate -Trilithon Titanium Metal-Backed Patella K132624, GENESIS II Total Knee System- Patella K951987
Porous Tibia Baseplate Predicate - LEGION Porous + HA Tibial Baseplates K100897, JOURNEY Non-Porous Tibia Baseplates K042515, Genesis II Porous Tibial Trays and Revision Knee System K053274
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ZUK UHMWPE Articular Surface K033363, REDAPT CONCELOC Fully Porous Cup K181366
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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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3
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 Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 09, 2021 |
| Contact Person and Address: | Mr. Brad Sheals, MS
Senior Regulatory Affairs Manager
Mobile: (901) 288-7141 |
| Secondary Contact Person and
Address: | Mrs. Michelle Huettner, RAC
Regulatory Affairs Director
Mobile: (765) 426-6070 |
| Name of Device: | Porous Patella and Porous Tibia Baseplate |
| Common Name: | Patella and Tibia Baseplate |
| Device Classification Name and
Reference: | 21 CFR 888.3565 - Knee joint patellofemorotibial
metal/polymer porous-coated uncemented
prosthesis (Primary classification) |
| | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MBH and JWH |
| Predicate Device: | Porous Patella Predicate -
Triathlon® Titanium® Metal-Backed Patella
K132624 (Primary predicate)
GENESIS II Total Knee System- Patella K951987 |
| | Reference predicate devices include-
ZUK™ UHMWPE Articular Surface K033363
REDAPT CONCELOC Fully Porous Cup K181366 |
| | Porous Tibia Baseplate Predicate -
LEGION Porous + HA Tibial Baseplates K100897
(Primary predicate)
JOURNEY Non-Porous Tibia Baseplates
K042515
Genesis II Porous Tibial Trays and Revision Knee
System 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.
5
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 | Submission
Number | Clearance
Date |
|---------------------------------------|------------------------------------------------|----------------------|-------------------|
| Smith & Nephew
(Primary Predicate) | GENESIS II Total Knee System-
Patella | K951987 | 08/22/1995 |
| Stryker
Orthopaedics | 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 | Submission
Number | Clearance
Date |
|---------------------------------------|-------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew
(Primary Predicate) | GENESIS POROUS TIBIAL TRAYS
& REVISION KNEE SYSTEM | K953274 | 02/05/1996 |
| Smith & Nephew | LEGION Porous + HA Tibial
Baseplates | K100897 | 05/13/2010 |
| Smith & Nephew | Journey Non-Porous Tibia
Baseplate | 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.