(140 days)
Not Found
No
The 510(k) summary describes a mechanical implant (femoral stem) and its associated testing (mechanical, coating, MR compatibility, biocompatibility). There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on the physical properties and safety of the implant itself.
Yes
The device is a femoral stem intended for hip arthroplasty to treat conditions like degenerative joint disease, addressing physical impairments and restoring function.
No
This device is a femoral stem implant used in hip replacement surgery, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states that the device consists of "femoral stem implants" made of "forged titanium alloy" with a "CP-Ti and HA coating." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing conditions like osteoarthritis, avascular necrosis, and fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a femoral stem implant made of titanium alloy with coatings, designed to be surgically implanted into the femur. This is a medical device used for structural support and joint replacement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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 CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty 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 non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.
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)
Mechanical Testing and Analyses
- · Distal Fatigue Testing per ISO 7206-4 and ASTM F2996-20
- · Neck Fatigue Testing per ISO 7206-6 and ASTM F2996-20
- · Range of Motion (ROM) Evaluation per ISO 21535
- · Engineering Analysis of Impingement Performance
- · Fretting and Corrosion Performance Rationale
- · Femoral Head Disassembly Performance Rationale
Hydroxyapatite (HA) Coating Testing
- · Chemical Characterization per ASTM F1980-21, ISO 13779-2 and ISO 13779-3
- · Static Tensile Attachment Strength Testing per ASTM F1 147-05 and ISO 13779-4
- · Static Shear Attachment Testing per ASTM F1044-05R17e01
- · Shear Fatigue Strength Testing per ASTM F1044-05R17e01 and ASTM F1160-14
- · Dissolution Rate and Solubility Product
MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017 and ASTM F2119-07
Biocompatibility per ISO 10993-1
No clinical tests were performed to support safety and efficacy of the subject device.
The performance mechanical and coating testings and analyses were used as a basis for the determination of substantial equivalence. The results of each of these tests show that when compared to the subject device has met the required acceptance criteria and there are no additional risks. As such, the CATALYSTEM Femoral Stems are substantially equivalent to the predicate devices for the intended use.
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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2024
Smith & Nephew Inc. Chelsea Bagley Sr. Regulatory Affairs Specialist 1450 Brooks Rd Memphis, Tennessee 38116
Re: K240381
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 7, 2024 Received: May 31, 2024
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 (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.
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"
1
(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 OS 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 and Part 809); 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-safetyreporting-combination-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.
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 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. Christopher Ferreira -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
2
Indications for Use
510(k) Number (if known) K240381
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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(k) #: K240381 | 510(k) Summary | Prepared on: 2024-06-27 |
|---|---|---|
| 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 | 4705058820 | |
| 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 | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | |
| uncemented prosthesis | ||
| Classification Name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or | |
| Non-Porous, Uncemented | ||
| 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 |
| K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral | LZO |
| K052792 | ANTHOLOGY Hip Stem | JDI |
| Device Description Summary | ||
| 21 CFR 807.92(a)(4) | ||
| The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. The | ||
| CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty 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 non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.
The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
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 osteoarhitis, avascular necrosis, and traumatic arthritis.
4
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 were updated to clarify the type of hip arthroplasty they are indicated for.
Technological Comparison
The overall technological characteristics including device design, function, materials and intended use for the CATALYSTEM Femoral Stems are substantially equivalent to the predicate Smith & Nephew systems cleared under the premarket notifications ANTHOLOGY Hip Stems (K052792, 10/07/2005) and POLARSTEM Hip Stems (K143739, 04/20/2015). The indications for use of the subject device were updated to clarify the type of hip arthroplasty they are indicated for.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Mechanical Testing and Analyses
- · Distal Fatigue Testing per ISO 7206-4 and ASTM F2996-20
- · Neck Fatigue Testing per ISO 7206-6 and ASTM F2996-20
- · Range of Motion (ROM) Evaluation per ISO 21535
- · Engineering Analysis of Impingement Performance
- · Fretting and Corrosion Performance Rationale
- · Femoral Head Disassembly Performance Rationale
Hydroxyapatite (HA) Coating Testing
- · Chemical Characterization per ASTM F1980-21, ISO 13779-2 and ISO 13779-3
- · Static Tensile Attachment Strength Testing per ASTM F1 147-05 and ISO 13779-4
- · Static Shear Attachment Testing per ASTM F1044-05R17e01
- · Shear Fatigue Strength Testing per ASTM F1044-05R17e01 and ASTM F1160-14
- · Dissolution Rate and Solubility Product
MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017 and ASTM F2119-07 Biocompatibility per ISO 10993-1
No clinical tests were performed to support safety and efficacy of the subject device.
The performance mechanical and coating testings and analyses were used as a basis for the determination of substantial equivalence. The results of each of these tests show that when compared to the subject device has met the required acceptance criteria and there are no additional risks. As such, the CATALYSTEM Femoral Stems are substantially equivalent to the predicate devices for the intended use.