(106 days)
Not Found
No
The 510(k) summary describes a hip implant component (acetabular shell) and its coating. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing and coating properties, not algorithmic performance.
Yes.
The device is a hip component used in surgery to rehabilitate hips damaged by trauma or degenerative joint diseases, which directly describes a therapeutic intent.
No
This device is described as a hip component (R3 HA Coated Acetabular Shells) used for primary and revision hip surgery, indicating it is an implantable medical device for treatment, not diagnosis. The "Intended Use / Indications for Use" section details conditions for which the hip components are indicated, all of which are related to existing damage or disease requiring surgical intervention, not the identification or assessment of a medical condition.
No
The device description clearly states it is a physical hip component (acetabular shells) with a coating, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (acetabular shell) with a coating, designed to be surgically placed in the body. This is consistent with a medical device, not an IVD which is used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
MBL, LZO, LPH, JDI, MEH, LWJ
Device Description
The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 Ha Coated Acetabular Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 HA Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
The locking mechanism is the same as for the predicate R3 acetabular shell. Therefore, all testing previously conducted confirmed that the device should perform as intended. Testing conducted on the StikTite coating and hydroxyapatite according to FDA guidance confirmed that the coatings met applicable requirements.
Clinical data was not necessary to support a decision of substantial equivalence.
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.
K060630, K061253, K070756, K092386, K090982
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 & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2020
Smith & Nephew, Inc. John Reabe Director, Regulatory Affairs 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K201701
Trade/Device Name: R3 HA Coated Acetabular Shells Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBL, LZO, LPH, JDI, MEH, LWJ Dated: September 3, 2020 Received: September 4, 2020
Dear John Reabe:
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
1
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 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,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201701
Device Name R3 HA Coated Acetabular Shells
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, 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) |
|---|
| ------------------------------------------------- |
X 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."
3
K201701 510(k) Summary R3 HA Coated Acetabular Shells
I. Submitter
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
Contact Person: John Reabe Director Email: john.reabe@smith-nephew.com Phone: 901-399-6670
Date of Summary: October 1, 2020
II: Device
| Proprietary Name: | R3 HA Coated Acetabular Shells |
|---|---|
| Common Name: | Artificial Hip Prosthesis |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR Section 888.3358 Hip joint metal/polymer/metal |
| semi-constrained porous-coated uncemented prosthesis | |
| Device Product Codes: | MBL, LZO, LPH, JDI, MEH, LWJ |
| Panel: | Orthopedic |
III. Predicate Devices
| Device | Manufacturer | 510(k) No. | Clearance Date |
|---|---|---|---|
| Primary Predicate | |||
| Reflection 3 Acetabular System | Smith & Nephew | K060630 | |
| K061253 | |||
| K070756 | |||
| K092386 | 06/14/2006 | ||
| 05/31/2006 | |||
| 06/06/2007 | |||
| 11/03/2009 | |||
| Predicates | |||
| Hip Systems with HA including | |||
| Reflection Shells with HA | Smith & Nephew | K090982 | 04/21/2010 |
IV. Device Description
The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 HA Coated Acetabular
4
K201701 510(k) Summary R3 HA Coated Acetabular Shells
Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 Ha Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.
V. Indications for Use
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, 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; fracturedislocation of the hip; and correction of deformity.
VI. Comparison of Technological Characteristics with the Predicate Devices
The R3 HA Coated Acetabular Shells are technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. The R3 HA Coated Acetabular Shells are manufactured from the same materials as the listed predicates. The shells are available in sizes with the same outer diameter. The locking mechanism is the same as for the predicate R3 Acetabular Shells. The R3 HA Coated Acetabular Shells are used with the same acetabular inserts that are used with the predicate R3 Acetabular Shells. Lastly, the asymmetric StikTite porous coating is the same as for the predicate Reflection 3 Acetabular Shells and the HA coating is the same as for the predicate Reflection Shells with HA.
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.
5
K201701 510(k) Summary R3 HA Coated Acetabular Shells
VII. Performance Data
The locking mechanism is the same as for the predicate R3 acetabular shell. Therefore, all testing previously conducted confirmed that the device should perform as intended. Testing conducted on the StikTite coating and hydroxyapatite according to FDA guidance confirmed that the coatings met applicable requirements.
Clinical data was not necessary to support a decision of substantial equivalence.
VIII. Conclusions
A review of the device indications, material composition, shell design, and technological characteristics confirmed that the R3 HA Coated Acetabular Shells are substantially equivalent to the predicate devices. While the R3 HA Coated Acetabular Shells are not identical to the predicate devices, comparisons of the subject and predicate devices confirmed that any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices. Therefore, it is concluded that the R3 HA Coated Acetabular Shells are substantially equivalent to the predicate devices.