(437 days)
K052792, K171934, K962541, K040680, K970351, K823727, K983834, K023302, K963486, K021673, K022902, K022958, K072817, K083762, K093363, K100412, K110101, K914878, K963509, K971414, K093991, K921400, K900628, K070278, K110135, K122244, K130728, K143739, K070756, K083566, K092386, K093363, K102370, K113848, K182535, K081124, K100481, K121627, K151902, K162303, K150790, K160923, K171073, K182109, K002747, K021803, K022556, K022902, K033442, K071160, K920430, K932755, K990666, K960094, K002747, K103256, K123012, K072852, K093991, K120211, K122296, K823723, K831884, K970351, K791125, K002996, K963509, K970337, K990369, K991485, K023743, K896580, K934353
Not Found
No
The summary explicitly states that no modifications have been made to the device's design, material, sterilization, and manufacturing processes, and the purpose of the 510(k) is solely to add "MR Conditional" labeling. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a hip implant system intended for treating various degenerative joint diseases, fractures, and for revision procedures, directly indicating its therapeutic purpose of restoring joint function and relieving pain.
No
The device description indicates that the purpose of the submission is to add "MR Conditional" labeling to existing hip systems. The intended use/indications for use describe the conditions for which the hip components are used, which are for treatment and rehabilitation, not diagnosis.
No
The device description explicitly states the purpose is to add "MR Conditional" labeling to existing "Smith & Nephew Hip Systems," which are physical hip implants. The submission focuses on testing the compatibility of these physical devices with MRI, not on a standalone software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as components for hip replacement surgery to treat various joint diseases, fractures, and deformities. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The device description confirms it's a hip system and the purpose of the submission is to add "MR Conditional" labeling. This further reinforces its nature as a physical implant.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Anatomical Site: The anatomical site is the hip joint and surrounding bone, consistent with a surgical implant.
IVD devices are used outside the body to examine specimens. This device is implanted inside the body.
N/A
Intended Use / Indications for Use
For Tandem Bipolar/Unipolar Hip System: The components are indicated for the following: 1. Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatment or devices have failed; and 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
For Synergy Hip System, Spectron EF Hip System, SL-Plus and SLR-Plus Cementless Femoral Hip System, Short Monoblock Femoral (SMF) Hip System, Reflection All-Poly Cup, Redapt Monoblock Revision Femoral System, R3 Acetabular System, HI Cup, Femoral Heads, Echelon Hip System, CPCS Cemented Hip System, Contour Acetabular System, Anthology 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 (NID/D) 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 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.
For Reflection Acetabular System - Metal Shell: The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
For Redapt Revision Acetabular 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 (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped captal 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; fracture dislocation of the hip; and correction of deformity.
For POLARSTEM: 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
For POLARCUP: 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement 4. All forms of osteoarthritis 5. Patients with hips at risk of dislocation 6. Femoral neck fracture or proximal fracture to hip joint The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
For Modular Hip Stems: The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.
For BH Dual Mobility System: The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LPH, MEH, LZO, KWY, MBL, KWZ
Device Description
The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint, Proximal Femur
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)
Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed below:
-
- FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021.
-
- Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
-
- IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
-
- ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020).
-
- ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device".
-
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
-
- ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
-
- ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
-
- ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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.
K052792, K171934, K962541, K040680, K970351, K823727, K983834, K023302, K963486, K021673, K022902, K022958, K072817, K083762, K093363, K100412, K110101, K914878, K963509, K971414, K093991, K921400, K900628, K070278, K110135, K122244, K130728, K143739, K070756, K083566, K092386, K093363, K102370, K113848, K182535, K081124, K100481, K121627, K151902, K162303, K150790, K160923, K171073, K182109, K002747, K021803, K022556, K022902, K033442, K071160, K920430, K932755, K990666, K960094, K002747, K103256, K123012, K072852, K093991, K120211, K122296, K823723, K831884, K970351, K791125, K002996, K963509, K970337, K990369, K991485, K023743, K896580, K934353
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.
Not Found
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
Smith & Nephew, Inc. Michelle Huettner Director, Regulatory Affairs, Orthopaedic Division 1450 East Brooks Rd Memphis. Tennessee 38116
Re: K211176
Trade/Device Name: Smith & Nephew Hip Systems 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, KWY, MBL, KWZ Dated: May 31, 2022 Received: June 1, 2022
Dear Rose Beifuss:
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 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
1
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 (QS) 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 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-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,
for
Limin Sun, Ph.D. Acting 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:
List of Cleared Devices in K211176
2
List of Cleared Devices in K211176
-
- Anthology Hip System MR Conditional
-
- BH Dual Mobility System MR Conditional
-
- Contour Acetabular System MR Conditional
-
- CPCS Cemented Hip System MR Conditional
-
- Echelon Hip System MR Conditional
-
- Femoral Heads MR Conditional
-
- HI Cup MR Conditional
-
- Modular Hip Stems MR Conditional
-
- POLARCUP MR Conditional
-
- POLARSTEM MR Conditional,
-
- R3 Acetabular System MR Conditional
-
- Redapt Monoblock Revision Femoral System MR Conditional
-
- Redapt Revision Acetabular System MR Conditional
-
- Reflection Acetabular System Metal Shell MR Conditional
-
- Reflection All-Poly Cup MR Conditional
-
- Short Monoblock Femoral (SMF) Hip System MR Conditional
-
- SL-Plus and SLR-Plus Cementless Femoral Hip System MR Conditional
-
- Spectron EF Hip System MR Conditional
-
- Synergy Hip System MR Conditional
-
- Tandem Bipolar/Unipolar Hip System MR Conditional
3
510(k) Number (if known)
K211176
Device Name
Tandem Bipolar/Unipolar Hip System
Indications for Use (Describe)
The components are indicated for the following:
-
Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis;
-
Rheumatoid arthritis;
-
Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
-
Revision procedures where other treatment or devices have failed; and
-
Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
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
4
510(k) Number (if known)
Device Name 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 (NID/D) 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 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.
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
5
510(k) Number (if known)
Device Name Spectron EF 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 (NID) 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 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.
| 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
6
510(k) Number (if known)
K211176
Device Name
SL-Plus and SLR-Plus Cementless Femoral 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 (NID) 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 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.
| 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
7
510(k) Number (if known)
K211176
Device Name Short Monoblock Femoral (SMF) 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 (NID) 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 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.
| 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
8
510(k) Number (if known)
Device Name Reflection All-Poly Cup
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 (NID) 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 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.
| 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
9
510(k) Number (if known)
K211176
Device Name Reflection Acetabular System - Metal Shell
Indications for Use (Describe)
The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
| 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
10
510(k) Number (if known)
Device Name Redapt Revision Acetabular 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 (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped captal 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; fracture dislocation of the hip; and correction of deformity.
| 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
11
510(k) Number (if known)
Device Name Redapt Monoblock Revision Femoral 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 (NID/D) 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 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.
| 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
12
510(k) Number (if known)
Device Name R3 Acetabular 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 (NID) 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 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.
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
13
510(k) Number (if known)
Device Name POLARSTEM
Indications for Use (Describe)
-
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
-
Fracture or avascular necrosis of the femoral head
-
Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted 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)
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
14
510(k) Number (if known)
Device Name POLARCUP
Indications for Use (Describe)
-
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
-
Fracture or avascular necrosis of the femoral head
-
Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
-
All forms of osteoarthritis
-
Patients with hips at risk of dislocation
-
Femoral neck fracture or proximal fracture to hip joint
The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
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
15
510(k) Number (if known)
Device Name Modular Hip Stems
Indications for Use (Describe)
The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.
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."
EF
16
510(k) Number (if known)
Device Name HI Cup
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 (NID/D) 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 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.
| 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
17
510(k) Number (if known)
Device Name Femoral Heads
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 (NID/D) 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 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.
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
18
510(k) Number (if known)
Device Name Echelon 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 (NID/D) 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 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.
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
19
510(k) Number (if known)
K211176
Device Name CPCS Cemented 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 (NID/D) 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 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.
| 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
20
510(k) Number (if known)
Device Name Contour Acetabular 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 (NID) 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 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.
| 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
21
510(k) Number (if known)
Device Name BH Dual Mobility System
Indications for Use (Describe)
The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
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."
EF
22
510(k) Number (if known)
Device Name Anthology 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 (NID/D) 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 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.
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
23
510(k) Summary
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | 31May2022 |
| Contact Person: | Rose Beifuss
Regulatory Affairs Specialist II
T +1.385.253.2551 |
| Name of Device: | Smith & Nephew Hip Systems: Anthology Hip
System, BH Dual Mobility System, Contour
Acetabular System, CPCS Cemented Hip System
Echelon Hip System, Femoral Heads, HI Cup
Modular Hip Stems, Polarcup, Polarstem, R3
Acetabular System, Redapt Monoblock Revision
Femoral System, Redapt Revision Acetabula
System, Reflection Acetabular System - Metal Shell
Reflection All-Poly Cup, Short Monoblock Femora
(SMF) Hip System, SL-Plus and SLR-Plus
Cementless Femoral Hip System, Spectron EF Hip
System, Synergy Hip System and Tandem
Bipolar/Unipolar Hip System. |
| Common Name: | Hip Stem, Acetabular Component, , Prosthetic Hip
Joint- HA Coated Porous Femoral Stem, Femoral |
| | Component, Cementless, Acetabular Liners, Femoral
Hip Prosthesis, Total Hip Joint, Acetabular
Component, Constrained Liner, Bipolar System |
| Device Classification Name
and Reference: | 21 CFR 888.3350- Hip joint metal/polymer semi-
constrained cemented prosthesis,
21 CFR 888.3358 – Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented
prosthesis,
CFR 888.3390- Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis,
21 CFR 888.3353- Hip joint metal/ceramic/polymer
semi-constrained cemented or nonporous
uncemented prosthesis,
21 CFR 888.3360 – Hip joint femoral (hemi-hip)
metallic cemented or uncemented prosthesis
21 CFR 888.3310 Prothesis, hip, constrained,
cemented or uncemented metal/polymer |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JDI , LPH, MEH, LZO, KWY, MBL, KWZ |
| Primary Predicate Device: | Anthology Hip System |
Femoral
Heads and Acetabular Liners, Total Hip Joint,
24
25
Additional Predicate Devices: BH Dual Mobility System, Contour Acetabular System, CPCS Cemented Hip System, Echelon Hip System, Femoral Heads, HI Cup, Modular Hip Stems, Polarcup, Polarstem, R3 Acetabular System, Redapt Monoblock Revision Femoral System, Redapt Revision Acetabular System, Reflection Acetabular System - Metal Shell, Reflection All-Poly Cup, Short Monoblock Femoral (SMF) Hip System, SL-Plus and SLR-Plus Cementless Femoral Hip System, Spectron EF Hip System, Synergy Hip System and Tandem Bipolar/Unipolar Hip System.
26
Device Description:
The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged.
No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.
Indications for Use:
Total Hip Systems
Anthology, Contour Acetabular, CPCS Cemented, Echelon, Femoral Heads, HI Cup, R3 Acetabular, Redapt Monoblock Revision Femoral, Redapt Revision Acetabular, Reflection All-Poly Cup, Short Monoblock Femoral, SL-Plus and SLR-Plus Cementless Femoral, Spectron EF, Synergy, BH Dual Mobility
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.
27
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; fracture dislocation of the hip; and correction of deformity.
Modular Hip Stems
The indications for use in total hip arthroplasty include rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.
POLARCUP
-
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
-
Fracture or avascular necrosis of the femoral head
-
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis,
-
- All forms of osteoarthritis
-
- Patients with hips at risk of dislocation
-
- Femoral neck fracture or proximal fracture to hip joint
The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> ThePOLARCUP Dual Mobility System is intended for single use only.
POLARSTEM
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis
-
- Fracture or avascular necrosis of the femoral head
-
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis,
28
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
Reflection Acetabular System - Metal Shell
The components are intended 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, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
BH Dual Mobility System
The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BH) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.
Partial Hip Systems
Tandem Bipolar/Unipolar
Tandem Bipolar/Unipolar Hip System
The components are indicated for the following:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
-
- Rheumatoid arthritis;
-
- Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
-
- Revision procedures where other treatment or devices have failed; and
-
- Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
29
Technological Characteristics
The device design and material of the subject devices are the same as the predicate Smith & Nephew Hip Systems cleared under the premarket notifications listed in Table 6.1.
Performance Data
Below listed Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed below.
-
- FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021.
-
- Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
-
- IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
-
- ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020).
-
- ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device".
-
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
-
- ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
-
- ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
-
- ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
30
Substantial Equivalence Information
The subject Smith & Nephew Hip Systems are identical in design, technological characteristics, function of the devices, packaging and sterilization to the commercially available predicate devices listed in Table 6.1 below. The only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of "MR Conditional" information to the labeling.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Smith & Nephew,
Inc. | Anthology Hip System | K052792 | 10/07/2005 |
| Smith & Nephew,
Inc. | BH Dual Mobility System | K171934 | 11/30/2017 |
| Smith & Nephew,
Inc. | Contour Acetabular System | K962541
K040680 | 09/17/1996
06/14/2004 |
| Smith & Nephew,
Inc. | CPCS Cemented Hip System | K970351
K823727 | 02/28/1997
03/08/1983 |
| Smith & Nephew,
Inc. | Echelon Hip System | K983834
K023302
K963486 | 02/24/1999
10/25/2002
11/27/1996 |
| Smith & Nephew,
Inc. | Femoral Heads | K021673
K022902
K022958
K072817
K083762
K093363
K100412
K110101
K914878
K963509
K971414 | 06/11/2002
10/02/2002
10/02/2002
05/15/2008
03/11/2009
01/26/2010
05/05/2010
04/11/2011
07/30/1992
01/27/1997
07/16/1997 |
| Smith & Nephew,
Inc. | HI Cup | K093991 | 04/15/2010 |
| Smith & Nephew,
Inc. | Modular Hip Stems | K921400
K900628 | 04/02/1993
05/09/1990 |
| Smith & Nephew,
Inc. | POLARCUP | K070278
K110135
K122244 | 04/16/2007
10/14/2011
08/23/2012 |
| Smith & Nephew,
Inc. | POLARSTEM | K130728
K143739 | 10/10/2013
04/20/2015 |
| Smith & Nephew,
Inc. | R3 Acetabular System | K070756
K083566
K092386
K093363
K102370
K113848
K182535 | 06/06/2007
03/03/2009
11/03/2009
01/26/2010
01/19/2011
04/27/2012
11/19/2018 |
| Smith & Nephew,
Inc. | Redapt Monoblock Revision
Femoral System | K081124
K100481
K121627
K151902
K162303 | 07/31/2008
07/15/2010
10/15/2012
09/03/2015
05/01/2017 |
| Smith & Nephew,
Inc. | Redapt Revision Acetabular
System | K150790
K160923
K171073
K182109 | 11/16/2015
11/17/2016
11/21/2017
11/16/2018 |
| Smith & Nephew,
Inc. | Reflection Acetabular System -
Metal Shell | K002747
K021803
K022556
K022902
K033442
K071160
K920430
K932755
K990666
K960094 | 12/15/2000
12/19/2002
08/28/2002
10/02/2002
11/26/2003
10/05/2007
07/21/1992
05/06/1994
08/06/1999
03/27/1996 |
| Smith & Nephew,
Inc. | Reflection All-Poly Cup | K002747 | 12/15/2000 |
| Smith & Nephew,
Inc. | Short Monoblock Femoral (SMF)
Hip System | K103256
K123012 | 01/31/2011
10/24/2012 |
| Smith & Nephew,
Inc. | SL-Plus and SLR-Plus Cementless
Femoral Hip System | K072852
K093991
K120211
K122296 | 06/09/2008
04/15/2010
07/19/2012
08/28/2012 |
| Smith & Nephew,
Inc. | Spectron EF Hip System | K823723
K831884
K970351
K791125 | 03/09/1983
09/20/1983
02/28/1997
06/27/1979 |
| Smith & Nephew,
Inc. | Synergy Hip System | K002996
K963509
K970337
K990369
K991485 | 12/11/2000
01/27/1997
02/28/1997
03/12/1999
07/12/1999 |
| Smith & Nephew,
Inc. | Tandem Bipolar/Unipolar Hip
System | K023743
K896580
K934353 | 01/23/2003
02/15/1990
04/25/1994 |
Table 6.1: Predicate Devices
31
32
Conclusion
In summary, the only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of MR safety information to the labeling. These differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the subject devices. The subject Smith & Nephew Hip Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared and do not affect the safety and effectiveness of the subject devices when used as labeled. Due to the supporting documentation within this filing, it is conducted that the subject device(s) are substantially equivalent to the predicate device(s).