(89 days)
Not Found
No
The document describes a mechanical implant and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a prosthesis intended to replace a hip joint, which is a therapeutic intervention for medical conditions.
No
The R3 Constrained Liner Acetabular System is described as a prosthesis intended to replace a hip joint. Its function is to provide mechanical support and stability, not to diagnose a condition.
No
The device description clearly states the device is a physical implant made of various metallic and polymeric materials, intended to replace a hip joint. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "cemented or uncemented prosthesis intended to replace a hip joint." This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the materials and components of a hip implant (liners, shells made of CoCr, Ti-6AI-4V, and UHMWPE). These are materials used in surgical implants, not in vitro diagnostic tests.
- Anatomical Site: The anatomical site is the "Hip joint," which is a part of the human body where a surgical procedure is performed.
- Performance Studies: The performance studies described are mechanical tests related to the physical properties and stability of the implant, not tests on biological samples.
In vitro diagnostics (IVDs) are devices used to examine specimens from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical implant used within the body to replace a joint.
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 Liners were previously cleared for market via premarket notification K111635. Subject of this premarket notification are minor modifications to the R3 Constrained Liner components, specifically the bipolar shell and inner poly liner.
The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6AI-4V, and ASTM F648 UHMWPE.
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)
Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address simulated intraoperative dislocation. A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111635, K021803, K033442, P960054
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
510K
Summary
K122139 (pg 1/2)
> We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | October 12, 2012 |
| Contact Person and Address: | Martin Ostmann
Regulatory Affairs Specialist
T (901) 399-1809
F (901) 566-7086 |
| Name of Device: | Smith & Nephew, Inc. R3 Constrained Liner |
| Common Name: | Acetabular Liner, Constrained |
| Device Classification Name and
Reference: | 21 CFR 888.3310 Hip joint metal/polymer constrained
cemented or uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KWZ |
OCT 1 6 2012#### Device Description
The R3 Constrained Liners were previously cleared for market via premarket notification K111635. Subject of this premarket notification are minor modifications to the R3 Constrained Liner components, specifically the bipolar shell and inner poly liner.
The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6AI-4V, and ASTM F648 UHMWPE.
Technological Characteristics
Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address simulated intraoperative dislocation. A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
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 acetabular components have been considered. The R3 Constrained Liner is intended for single use only.
1
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the R3 Constrained Liners cleared via premarket notification K111635.
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|-------------------------------|----------------------|--------------------------|
| Smith & Nephew,
Inc. | R3 Constrained Liner | K111635 | 9/9/2011 |
| Smith & Nephew,
Inc. | Reflection Constrained Liners | K021803
K033442 | 12/19/2002
11/26/2003 |
| Depuy, A J&J
Company | S-Rom Constrained Liner | P960054 | 6/19/1997 |
Table 1: Substantially equivalent predicates to the R3 Constrained Liner
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified R3 Constrained Liners. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate constrained hip systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 16 2012
Smith and Nephew, Incorporated % Mr. Martin Ostmann Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
Re: K122139
Trade/Device Name: R3 Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: KWZ
Dated: July 17, 2012 Received: July 19, 2012
Dear Mr. Ostmann:
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. 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 (reporting of medical
3
Page 2 - Mr. Martin Ostmann
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
yours,
For
Melkerson
Mark N. Melkersoi Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known): K122139 (pg 1/1)
R3 Constrained Liner Device Name:
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 × (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K Asmali
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122139
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