LANDMARK Total Knee System
Device Facts
| Record ID | K261462 |
|---|---|
| Device Name | LANDMARK Total Knee System |
| Applicant | Smith & Nephew, Inc. |
| Product Code | MBH · Orthopedic |
| Decision Date | Sep 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3565 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement.
Device Story
LANDMARK CR Porous Femoral component; part of total knee arthroplasty system. Device replaces damaged knee joint surfaces; provides structural support for joint articulation. Composed of CoCrMo alloy with CONCELOC porous biological fixation surface; includes two Ti-6Al-4V alloy lugs. Used in orthopedic surgery; implanted by surgeons. Compatible with various inserts and patellar components from Journey and Genesis II systems. Provides mechanical stability and fixation for knee joint; enables patient mobility. Gamma sterilized; single-use.
Clinical Evidence
No clinical tests performed. Substantial equivalence supported by bench testing: tibiofemoral/patellofemoral contact and constraint testing, durability/wear engineering analysis, FEA, fatigue testing, porous surface testing per FDA guidance, biocompatibility assessment, and MR compatibility assessment.
Technological Characteristics
CoCrMo alloy femoral component with additively manufactured CONCELOC porous biological fixation surface; Ti-6Al-4V alloy lugs. Sizes 1-12. Gamma sterilized. Single-use. Mechanical fixation (with or without bone cement).
Indications for Use
Indicated for skeletally mature adults requiring total knee arthroplasty due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, or failed unicompartmental or total knee replacements.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- LEGION POROUS PRIMARY (K073325, K230653)
- JOURNEY II CR KNEE SYSTEM (K121443, K230653)
- GENESIS II TOTAL KNEE SYSTEM (K951987, K030612)
- Porous Patella and Porous Tibia Baseplate (K211221, K230653)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
September 8, 2026
Smith & Nephew, Inc.
Jessica Roach
Senior Regulatory Affairs Specialist
1450 Brooks Rd.
Memphis, Tennessee 38116
Re: K261462
Trade/Device Name: LANDMARK Total Knee System
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: August 14, 2026
Received: August 17, 2026
Dear Jessica Roach:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261462 - Jessica Roach
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
{2}
K261462 - Jessica Roach
Page 3
assistance/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,
LIXIN LIU -S
Lixin Liu, Ph.D
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
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261462 | ? |
| Please provide the device trade name(s). | | ? |
| LANDMARK Total Knee System | | |
| Please provide your Indications for Use below. | | ? |
| The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement. Indications for Use: • Rheumatoid arthritis • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis • Failed unicompartmental or total knee replacements | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
{4}
| 510(k) #: K261462 510(k) Summary Prepared on: 2026-09-04 | | |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Smith & Nephew, Inc. | |
| Applicant Address | 1450 Brooks Road Memphis TN 38116 United States | |
| Applicant Contact Telephone | 978-474-6318 | |
| Applicant Contact | Ms. Jessica Roach | |
| Applicant Contact Email | jessica.roach@smith-nephew.com | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | LANDMARK Total Knee System | |
| Common Name | Total Knee System | |
| Classification Name | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis | |
| Regulation Number | 888.3565 | |
| Product Code(s) | MBH, JWH | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K073325, K230653 | LEGION POROUS PRIMARY | MBH |
| K121443, K230653 | JOURNEY II CR KNEE SYSTEM | JWH |
| K951987, K030612 | GENESIS II TOTAL KNEE SYSTEM | JWH, MBH |
| K211221, K230653 | Porous Patella and Porous Tibia Baseplate | MBH, JWH |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The device in scope of this submission is the LANDMARK CR Porous Femoral component of the LANDMARK Total Knee System. | | |
| The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement. Indications for use include rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; and failed unicompartmental or total knee replacements. | | |
| The LANDMARK CR Porous Femoral is offered in size 1 to 12 for left- and right-side configurations. The subject device is composed of Cobalt-Chromium-Molybdenum (CoCrMo) alloy with a porous biological fixation surface (CONCELOC) and has two lugs composed of Titanium-6 Aluminum-4 Vanadium (Ti-6Al-4V) alloy. The device is gamma sterilized and intended for single-use only. | | |
| The LANDMARK CR Porous Femoral component is compatible with the following components: Journey II CR Insert, Journey II Medial Dished Insert, Journey II Deep Dished Insert, Journey Round Patella, Journey Biconvex Patella, Genesis II Round Patella, Genesis II Oval Patella, Genesis II Biconvex Patella, Porous Patella, Cemented Round Patella w/ JRNY Pegs, Cemented Tibial Baseplate w/ JRNY Lock, Cemented Revision Tibial Baseplate w/ JRNY Lock, and CONCELOC Porous Tibial Baseplate. | | |
K261462 Page 1 of 2
{5}
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
| --- | --- |
| The Smith & Nephew LANDMARK Total Knee System is intended for total knee arthroplasty in skeletally mature patients. The LANDMARK CR Porous Femoral component is intended for use with or without bone cement. | |
| Indications for Use: • Rheumatoid arthritis • Post-traumatic arthritis, osteoarthritis, or degenerative arthritis • Failed unicompartmental or total knee replacements | |
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
| The subject LANDMARK CR Porous Femoral indications fall within the cleared predicates' indications for use. The minor differences between the subject device and cleared predicates' indications for use are due to the posterior stabilized (PS) and narrow femoral indications not being applicable to the subject device design. The subject device is not indicated for new indications when compared to its cleared predicates. | |
| Technological Comparison | 21 CFR 807.92(a)(6) |
| The overall technological characteristic including device design and material of the subject device is similar to that of the predicate Smith & Nephew systems cleared under the premarket notifications LEGION POROUS PRIMARY (K073325, SE 12/20/2007 & K230653, SE 05/04/2023), JOURNEY II CR KNEE SYSTEM (K121443, SE 08/13/2012 & K230653, SE 05/04/2023), and GENESIS II TOTAL KNEE SYSTEM (K951987, SE 08/22/1995 & K030612, SE 05/27/2003). The primary predicate LEGION POROUS PRIMARY is indicated for use without bone cement however the subject device is indicated for use with or without bone cement similar to the secondary predicate GENESIS II TOTAL KNEE SYSTEM and the Porous Patella and Porous Baseplate (K211221, SE 10/1/2021 & K230653, SE 05/04/2023). The subject device is gamma sterilized similar to all predicates listed. Additionally, the subject device is additively manufactured with a porous biological fixation surface (CONCELOC) similar to that of the Porous Patella and Porous Tibia Baseplate with the primary difference being that the predicate is manufactured with Ti-6Al-4V powder as opposed to the subject device manufactured with CoCrMo powder. There are differences in device geometry, dimensions, and sizes between the subject and predicate devices. The performance of the subject device was demonstrated through mechanical testing according to standards and predicate comparison and any differences in technological characteristic do not raise different safety or effectiveness issues. | |
| Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) |
| • Tibiofemoral constraint and contact area test • Patellofemoral contact area and subluxation test • Patellofemoral durability engineering analysis • Tibial insert endurance and deformation under high flexion test • Wear engineering analysis • Opening and closing mode finite element analysis (FEA) • Opening and closing mode fatigue test • Porous surface testing per FDA guidance on modified metallic surfaces • Biocompatibility assessment • MR compatibility assessment No clinical tests were performed to support safety and effectiveness of the subject devices. The performance bench tests were used as a basis for the determination of substantial equivalence. The results of these tests show that when compared to the predicate devices, the subject devices have met the required acceptance criteria and therefore demonstrate substantial equivalence with the predicate devices. | |
K261462 Page 2 of 2
