(214 days)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.
The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.
The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
Acetabular Hip Components are individuals undergoing primary and revision 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 theumatoid arthritis, congenital dysplasia. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocations of the hip.
The Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
The purpose of this Traditional 510(k) is the following:
-
- To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
-
- To address several iterative legacy design changes made to the subject hip system components.
This document is a 510(k) premarket notification for hip system components and does not describe an AI medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI algorithms.
The document primarily focuses on demonstrating substantial equivalence of the described hip system components to previously cleared predicate devices. The "Performance Data" section specifically mentions Magnetic Resonance Imaging (MRI) compatibility testing and "additional testing [...] to assess the modifications made to the subject Smith & Nephew Hip Systems devices against their predicates." This indicates performance data related to physical device properties, not AI performance.
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October 21, 2024
Smith & Nephew, Inc. Laurel Arrigona Senior Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
Re: K240783
Trade/Device Name: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LPH, MEH, LZO, LWJ, KWY, MBL, KWZ Dated: September 17, 2024 Received: September 19, 2024
Dear Laurel Arrigona:
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.
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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
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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,
Limin Sun -S
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
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Indications for Use
510(k) Number (if known) K240783
Device Name
Anthology Hip System, CPCS Cemented Hip System, Femoral Heads, Spectron Hip System, Synergy Hip System
Indications for Use (Describe)
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Total hip systems may be indicated for use (i) without bone cement, or (ii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.
Some of the diagnoses listed above may increase risk of complications and reduce the chance of a satisfactory result. Specifically, an increased risk of complications for revision surgery for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a high likelihood of revision in younger, heavier, or more active patients. Specifically, the risk of complications is greater in obese and morbidly obese patients.
The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.
The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
K240783 p.2/2
510(k) Number (if known) K240783
Device Name R3 Acetabular System
Indications for Use (Describe)
Acetabular Hip Components are individuals undergoing primary and revision 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 theumatoid 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 Constrained Liners are indicated for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Some of the diagnoses listed above are associated with an increased risk of complications and reduced chance of a satisfactory short- and long-term outcomes. Specifically, an increased risk of complications to revision surgeries for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level may negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a higher likelihood of revision in younger, heavier and/or more active patients. Specifications is higher in obese patients.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| Submitted by: | Smith & Nephew, Inc. Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 |
|---|---|
| Date of Submission: | October 19, 2024 |
| Contact Person: | Laurel ArrigonaRegulatory Affairs ManagerLaurel.arrigona@smith-nephew.comMobile: (682)758-2312 |
| Name of Device: | Anthology Hip StemsCPCS Hip StemsFemoral HeadsR3 Acetabular SystemSpectron Hip StemsSynergy Hip Stems |
| Common Name: | Prosthesis, hip, semi-constrained, metal/polymer,cementedProsthesis, hip, semi-constrained, uncemented,metal/polymer, porousProsthesis, hip, semi-constrained, uncemented,metal/polymer, non-porous, calcium phosphateProstheses, hip, semi-constrained, metal/polymer,porous uncementedProsthesis, hip, semi-constrained, metal/polymer,uncementedProsthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous, |
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| Device Classification Name andReference: | uncementedProsthesis, hip, constrained, cemented oruncemented, metal/polymerProsthesis, hip, hemi-, femoral, metal/polymer,cemented or uncemented21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis21 CFR 888.3353 Hip joint metal/ceramic/polymersemi-constrained cemented or nonporousuncemented prosthesis21 CFR 888.3360 Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis21 CFR 888.3310 Hip joint metal/polymerconstrained cemented or uncemented prosthesis21 CFR 888.3390 Hip joint femoral (hemi-hip)metal/polymer cemented or uncementedprosthesis |
|---|---|
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JDI, MBL, MEH, LPH, LWJ, LZO, KWZ, KWY |
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Predicate Devices:
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew,Inc. | Anthology Hip Stems | K052792 | 10/07/2005 |
| Smith & Nephew,Inc. | Global Taper Spectron Hip Stems | K970351 | 02/28/1997 |
| Smith & Nephew,Inc. | Global Taper Tapered Hip System,GT Spectron | K963509 | 01/27/1997 |
| Smith & Nephew,Inc. | R3 Multi-Hole Shells and 36mmXLPE Acetabular Liners | K092386 | 11/03/2009 |
| Smith & Nephew,Inc. | R3 XLPE Liners | K113848 | 04/27/2012 |
| Smith & Nephew,Inc. | Reflection 3 Acetabular System | K070756 | 06/06/2007 |
| Smith & Nephew,Inc | Porous and Non-Porous RevisionHip Stems of the Revision HipSystem and Heads with GlobalTaper | K963486 | 11/27/1996 |
| Smith & Nephew,Inc. | Smith & Nephew Hip Systems | K211176 | 07/01/2022 |
| Smith & Nephew,Inc. | Smith & Nephew MDF Revision HipSystem | K081124 | 07/31/2008 |
| Smith & Nephew,Inc. | Spectron Extra-Small StraightFemoral Prosthesis | K831884 | 09/20/1983 |
| Smith & Nephew,Inc. | Spectron Long, Straight FemoralProsthesis | K823722 | 03/08/1983 |
| Smith & Nephew,Inc. | Synergy Cemented Hip Stem | K990369 | 03/12/1999 |
| Smith & Nephew,Inc. | Synergy Porous Size 8 Hip Stem | K991485 | 07/12/1999 |
| Smith & Nephew,Inc. | Total Hip Femoral Heads - 12/14Taper | K021673 | 06/11/2002 |
Device Description:
The purpose of this Traditional 510(k) is the following:
-
- To add the MR safety information to the product labels and update the MR information within the package insert for the Smith & Nephew Hip Systems included within the scope of this 510(k), and
-
- To address several iterative legacy design changes made to the subject hip system components.
{8}------------------------------------------------
Indications for Use
Total Hip Systems Anthology Hip System, CPCS Cemented Hip System, Femoral Heads, Spectron Hip System, Synergy Hip System
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diaqnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocations of the hip; and correction of deformity.
Total hip systems may be indicated for use (i) with bone cement, (ii) without bone cement, or (iii) for use with or without bone cement. Refer to the product labeling and literature for specific applications.
Some of the diagnoses listed above may increase risk of complications and reduce the chance of a satisfactory result. Specifically, an increased risk of complications for revision surgery for any reason has been documented in the literature. Patient selection factors such as aqe, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a high likelihood of revision in younger, heavier or more active patients. Specifically, the risk of complications is greater in obese and morbidly obese patients.
The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only.
The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
Acetabular Hip Systems R3 Acetabular System
Acetabular Hip Components are indicated for individuals undergoing primary and
{9}------------------------------------------------
revision 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-dislocations of the hip.
The Constrained Liners are indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Some of the diagnoses listed above are associated with an increased risk of complications and reduced chance of a satisfactory short- and long-term outcomes. Specifically, an increased risk of complications to revision surgeries for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a high likelihood of revision in younger, heavier and/or more active patients. Specifically, the risk of complications is higher in obese patients.
Technological Characteristics
The device design and material of the subject Smith & Nephew Hip System devices are similar to the predicate Smith & Nephew Hip System devices cleared under the premarket notifications listed as predicates.
Performance Data
The Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance "Testing and Labeling Medical Devices for Safety in the Magnetic (MR) Environment", May 20, 2021 and the standards listed below .
- Magnetically induced displacement force (ASTM F2052)
- Magnetically induced torque (ASTM F2213)
- Radiofrequency (RF) induced heating (ASTM F2182-19e2, IEC 60601-2-33, ISO/TS 10974:2018E)
- . MR image artifact (ASTM F2119)
Additional testing was conducted to assess the modifications made to the subject Smith
{10}------------------------------------------------
& Nephew Hip Systems devices against their predicates.
Conclusion
The subject modified Smith & Nephew Hip Systems devices, comprised of Anthology Hip Stems, CPCS Hip Stems, Femoral Heads, R3 Acetabular System, Spectron Hip Stems, and Synergy Hip Stems, are substantially equivalent to their predicate devices. Additionally, MR labelling can be added to the subject devices due to the applicability of test results previously reviewed and cleared via K211176.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.