(261 days)
Not Found
No
The document describes a line extension of hip replacement components and focuses on mechanical testing and substantial equivalence to predicate devices. There is no mention of AI or ML.
Yes
The device, hip components, is used in primary and revision surgery to rehabilitate hips damaged by trauma or degenerative joint disease, indicating a therapeutic purpose to treat or alleviate a medical condition.
No
The device described is a hip component (R3 Large Head Liners), which is an implant used in surgery to replace or repair damaged hips. Its intended use is for treatment of conditions like degenerative joint disease or fractures, not for diagnosing them.
No
The device description clearly states that the subject of the 510(k) is "implants" and describes physical dimensions and materials, indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical procedures to replace or repair damaged hip joints. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as "Hip components" and "R3 Large Head Liners," which are physical implants intended to be surgically placed in the hip.
- Performance Studies: The performance studies mentioned are "Non-clinical bench (mechanical) testing," which is typical for orthopedic implants to assess their structural integrity and function, not for evaluating the performance of a diagnostic test on biological samples.
The information provided consistently points to this being a surgical implant, not an in vitro diagnostic device.
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; fracturedislocation of the hip; and correction of deformity.
The R3 Acetabular System is for single use only and is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO, MEH
Device Description
The subject of this Traditional 510k is the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). The R3 Large Head Liners are a line extension to the existing R3 Acetabular System. The R3 Large Head Liners were previously cleared for market via premarket notification K113848. The head size of the liners are being increased to include sizes 28mm X 44mm, 32mm X 46mm, and 36mm X 50mm (inner diameter and outer diameter, respectively) in 0 and 20-degree versions. The R3 Large Head Liners are intended for single use only. Similar head sizes have been cleared on R3 XLPE 36mm XLPE Liners via K092386, R3 40 and 44mm XLPE Liners via K093363, and REFLECTION 32mm X 50-52mm XLPE Acetabular Liner via K002747.
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)
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was performed on the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). A review of the testing indicates that the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm) are substantially equivalent to predicate devices listed in Table 6.1 above.
The following tests were used as a basis for the determination of substantial equivalence. The testing included the following:
- Lever-Out
- Push-Out
- Torque-Out
- Fatigue
- Post Fatigue Push-Out
- Biocompatibility
- Impingement
- Range of Motion
- Wear
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
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.
K113848, K092386, K093363, K002747
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
January 19, 2022
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Kayla Franklin Regulatory Affairs Specialist I 7135 Goodlett Farms Parkway Cordova. Tennessee 38016
Re: K211330
Trade/Device Name: R3 Large Head Liners 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: LPH, JDI, LZO, MEH Dated: December 17, 2021 Received: December 20, 2021
Dear Kayla Franklin:
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
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name R3 Large Head Liners
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, atturitis 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.
The R3 Acetabular System is for single use only and is intended for cementless use.
| 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.
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510(k) Summary
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | January 18, 2022 |
| Contact Person: | Kayla Franklin, Regulatory Affairs Specialist I
T (901) 800-3398
M (901) 325-2471 |
| Name of Device: | R3 Large Head Liners |
| Common Name: | Acetabular Liners |
| Device Classification Name
and Reference: | 21 CFR 888.3358 - Hip joint metal/polymer/metal
semi-constrained porous-coated uncemented
prosthesis. |
| Device Class: | Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | LPH (primary), JDI, LZO, MEH |
| Predicate Device: | R3 Large Head Liners |
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Device Description:
The subject of this Traditional 510k is the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). The R3 Large Head Liners are a line extension to the existing R3 Acetabular System. The R3 Large Head Liners were previously cleared for market via premarket notification K113848. The head size of the liners are being increased to include sizes 28mm X 44mm, 32mm X 46mm, and 36mm X 50mm (inner diameter and outer diameter, respectively) in 0 and 20-degree versions. The R3 Large Head Liners are intended for single use only. Similar head sizes have been cleared on R3 XLPE 36mm XLPE Liners via K092386, R3 40 and 44mm XLPE Liners via K093363, and REFLECTION 32mm X 50-52mm XLPE Acetabular Liner via K002747.
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.
The R3 Acetabular System is for single use only and is intended for cementless use.
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Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject devices, R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm - 36mm X 50mm), are substantially equivalent to the below listed legally marketed predicate devices (Table 6.1) with regard to intended use, indications for use, design, material and performance characteristics. Identical to that of the predicate R3 Large Head Liners cleared via premarket notification K113848 (S.E. 04/27/12), the subject R3 Large Head 0 and 20-degree implant liners (28mm X 44mm – 36mm) are also made from Cross Linked Polyethylene (XLPE), undergo the same manufacture process, have the same surface finish, and the same locking mechanism. The subject and predicate R3 liners also have similar inner and outer diameters, as well as being offered in similar design options. Additionally, the predicate R3 36mm XLPE Liners, K092386 (S.E. 11/03/09) and predicate R3 40 and 44mm XLPE Liners, K093363 (S.E. 01/26/10) have similar head sizes to that of the subject R3 Large Head liners.
Substantial Equivalence Information
The overall design, materials, and indications for use for the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm) are substantially equivalent to the predicate devices listed in Table 6.1 below. In addition to the similarities stated above in the Technological Characteristics, the subject devices also utilize the same sterilization method as their predicates. While the subject devices are not identical in design to the predicate devices, any differences that may exist between the subject device and the predicates identified below do not significantly affect the safety or effectiveness of the device.
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Table 6.1: Predicate Devices
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-------------------------|----------------------------------------------------|----------------------|-------------------|
| Smith & Nephew,
Inc. | R3 XLPE Liners (Primary
Predicate) | K113848 | 04/27/12 |
| Smith & Nephew,
Inc. | R3 36mm XLPE Liners | K092386 | 11/03/09 |
| Smith & Nephew,
Inc. | R3 40 and 44mm XLPE Liners | K093363 | 01/26/10 |
| Smith & Nephew,
Inc. | REFLECTION 32mm X 50-52mm
XLPE Acetabular Liner | K002747 | 12/15/00 |
Performance Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was performed on the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). A review of the testing indicates that the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm) are substantially equivalent to predicate devices listed in Table 6.1 above.
The following tests were used as a basis for the determination of substantial equivalence. The testing included the following:
- Lever-Out
- Push-Out .
- Torque-Out ●
- Fatigue ●
- Post Fatigue Push-Out ●
- Biocompatibility ●
- Impingement ●
- Range of Motion ●
- Wear .
7
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
In summary, this 510(k) Premarket Notification is being submitted to request clearance for the R3 Large Head Liners 0 and 20-degree implants (28mm X 44mm – 36mm X 50mm). Based on the similarities to the predicate devices and a review of the bench testing, the subject devices are substantially equivalent to the commercially available predicate devices listed above.