(90 days)
No
The document describes a mechanical implant for hip replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthesis intended to replace a hip joint, which is a therapeutic intervention.
No
The R3 Constrained Liner Acetabular System is a prosthesis designed to replace a hip joint, not to diagnose a condition.
No
The device description clearly details a physical implantable medical device (acetabular system, liner, shell, bearing, rings) made of materials like polyethylene, intended for surgical implantation to replace a hip joint. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The R3 Constrained Liner Acetabular System is a prosthesis intended to replace a hip joint. It is an implantable device used directly within the body.
- Intended Use: The intended use is to replace a hip joint and address issues related to hip dislocation. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a medical device used for surgical implantation and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
Product codes
KWZ
Device Description
The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring.
The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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)
Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P960047, K021803, K023743, K030923
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
510(k) Summary Smith & Nephew R3 Constrained Liners
Ko 8 3566
3 2009 MAR
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN ,38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6017 |
| CONTACT PERSON: | Nicholas B. Tabrizi |
| DATE SUMMARY PREPARED: | December 2, 2008 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew R3 Constrained Liners |
| COMMON OR USUAL NAME: | Constrained Liner |
| CLASSIFICATION NAME: | 21 CFR 888.3310 - Hip Joint Metal/Polymer Constrained Cemented |
| or Uncemented Prosthesis | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | Orthopaedics/87 KWZ |
A. INTENDED USE:
The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acefabular components have been considered. The R3 Constrained Liner is intended for single use only.
в. DEVICE DESCRIPTION:
The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring.
The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.
ட் SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew R3 Constrained Liner is similar to the following commercially available devices regarding design features, overall indications, materials, sterilization and manufacturing:
| Manufacturer | Description | Submission
Number | Clearance Date |
|-----------------------|--------------------------------------------|----------------------|----------------|
| Osteonics Corporation | Osteonics Constrained
Acetabular Insert | P960047 | 6/10/1997 |
| Smith & Nephew, Inc. | REFLECTION Constrained Liner | K021803 | 12/23/2002 |
Table 14: Predicate Constrained Liner Systems
1
1
| Smith and Nephew,
| Inc. | Global Bipolar System | K023743 | 1/23/2003 |
|---|---|---|---|
| Centerpulse | |||
| Orthopaedics, Inc. | Epsilon Durasul Constrained | ||
| Acetabular Liner | K030923 | 10/03/2003 |
D. Summary of Technological comparison:
The intended use, design, and materials of the R3 Constrained Liners are substantially equivalent to the previously cleared Osteonics Constrained Liners (P960047). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
3 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Orthopaedic Division % Mr. Jason Sells Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116
Re: K083566
Trade/Device Name: Smith & Nephew R3 Constrained Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: December 2, 2008 Received: December 3, 2008
Dear Mr. Sells:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Jason Sells
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew R3 Constrained Liner
Indications for Use:
The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083566