(30 days)
No
The 510(k) summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are bench tests of mechanical properties.
Yes
The device is a femoral stem implant used in hip arthroplasty to treat conditions like degenerative joint disease, avascular necrosis, and fractures, which directly addresses medical conditions and injuries.
No
This device, the CATALYSTEM Femoral Stems, is an implant used in hip arthroplasty, which is a treatment for damaged hips. It acts as a prosthetic component, not a tool for diagnosing medical conditions.
No
The device description clearly states that the device consists of "femoral stem implants," which are physical hardware components intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The CATALYSTEM Femoral Stems are described as implants intended for surgical procedures (total and partial hip arthroplasty) to replace damaged hip joints. They are physical components implanted into the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose or detect a condition. Its function is mechanical and structural, replacing a damaged joint.
Therefore, the CATALYSTEM Femoral Stems fall under the category of surgical implants or orthopedic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:
Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
The CATALYSTEM Femoral Stems are intended for use without bone cement.
Product codes
LZO, MEH, LPH
Device Description
The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.
The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.
The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.
The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
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)
Bench Testing
· Neck Fatigue Testing per ISO 7206-6
· Engineering analysis for Distal Stem Fatigue (ISO 7206-4:2010)
· Engineering analysis for Range of Motion (ROM) (ISO 21535:2023)
· Engineering analysis for Impingement (ASTM F2582-20)
No clinical tests were performed to support safety and efficacy of the subject device.
The performance of the bench test was used as a basis for the determination of substantial equivalence testing demonstrate acceptable outcomes. The test shows that when compared to the predicate devices the subject device has met the required acceptance criteria and there are no additional risks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2025
Smith & Nephew Inc. Chelsea Bagley Sr. Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, Tennessee 38116
Re: K250571
Trade/Device Name: CATALYSTEM Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, LPH Dated: February 25, 2025 Received: February 26, 2025
Dear Chelsea Bagley:
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 (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.
1
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
2
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,
RYAN TROMBETTA -S
For: Limin Sun, 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
Submission Number (if known)
Device Name
CATALYSTEM Femoral Stems
Indications for Use (Describe)
The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:
Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
The CATALYSTEM Femoral Stems are intended for use without bone cement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ounter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K250571 | K250571 Page 1 of 2 | ||
|---|---|---|---|---|
| 510(k) Summary | Prepared on: 2025-03-26 | |||
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Smith & Nephew Inc. | |||
| Applicant Address | 1450 Brooks Rd. Memphis TN 38116 United States | |||
| Applicant Contact Telephone | (470) 505-8820 | |||
| Applicant Contact | Mrs. Chelsea Bagley | |||
| Applicant Contact Email | chelsea.bagley@smith-nephew.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | CATALYSTEM Femoral Stems | |||
| Common Name | Femoral Stem | |||
| Classification Name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | |||
| Regulation Number | 888.3353 | |||
| Product Code(s) | LZO, MEH, LPH | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K240381 | CATALYSTEM Femoral Stems | LZO | ||
| K052792 | ANTHOLOGY Hip Stem | JDI | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381. |
The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.
The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.
The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.
21 CFR 807.92(a)(5)
Intended Use/Indications for Use
The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:
Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in
5
K250571 Page 2 of 2
rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarhiftis, avascular necrosis, and traumatic arthritis.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
The CATALYSTEM Femoral Stems are intended for use without bone cement.
Indications for Use Comparison
The indications for use of the subject device are identical to the indications for use of the Primary Predicate.
Technological Comparison
The overall technological characteristics including device design, function, materials, intended use and indications for use for the CATALYSTEM Femoral Stems are identical to the primary predicate CATALYSTEM Femoral Stems cleared under the premarket notification listed above. The only difference in technological characteristic is the additional femoral head compatibility.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)
Bench Testing
· Neck Fatigue Testing per ISO 7206-6
· Engineering analysis for Distal Stem Fatigue (ISO 7206-4:2010)
· Engineering analysis for Range of Motion (ROM) (ISO 21535:2023)
· Engineering analysis for Impingement (ASTM F2582-20)
No clinical tests were performed to support safety and efficacy of the subject device.
The performance of the bench test was used as a basis for the determination of substantial equivalence testing demonstrate acceptable outcomes. The test shows that when compared to the predicate devices the subject device has met the required acceptance criteria and there are no additional risks.
21 CFR 807.92(a)(6)