(120 days)
No
The summary describes a modification to a physical hip implant component (acetabular liner) and focuses on mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a hip component used in surgery to replace damaged hips, which is a form of treatment for medical conditions.
No
Explanation: The device described is a hip component (acetabular liner) used in primary and revision hip surgery, which is a therapeutic rather than a diagnostic device. Its function is to replace or assist damaged hip structures, not to identify or characterize a disease or condition. The text details its indications for use in patients with damaged hips and modifications for surgical implantation, not for diagnosis.
No
The device description clearly states it is a modification to "R3 22-36mm XLPE Acetabular Liners," which are physical hip implant components. The summary also details mechanical testing of these physical liners.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or repairing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical component (acetabular liners) designed to be implanted in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) to provide information about a patient's health or condition.
- Performance Studies: The performance studies focus on mechanical testing of the device's physical properties and durability, which is typical for an implantable device, not an IVD.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a surgical implant used to treat a condition.
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.
The Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Product codes
MBL, MEH, LZO, JDI
Device Description
Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.
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
This 510(k) was prepared in accordance with the Agency's, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of the mechanical data indicates that the R3 22-36mm XLPE Acetabular Liners are capable of withstanding expected in vivo loading without failure. The following mechanical testing of the R3 XLPE Liners was performed:
- Push-out Testing .
- Torque-to-Failure Testing ●
- Lever-out Testing ●
- Fatigue Testing ●
- Post-Fatigue Push-out Testing ◆
A review of this testing has demonstrated 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
Not Found
Predicate Device(s)
K061253, K002747, K071160, K092386, K093363
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 2 7 2012
510(k) Summary R3 XLPE Acetabular Liners
Submitted by:
Smith & Nephew, Inc. Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
April 23, 2012
Contact Person and Address: John Connor, Regulatory Affairs Specialist T (901) 399-5944 F (901) 566-7961
Name of Device:
Date of Summary:
Common Name:
Device Classification Name and Reference:
Smith & Nephew, Inc R3 XLPE Acetabular Liners
Acetabular Liners
21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
| | 21 CRF 888.3350 Hip joint metal/polymer semi-
constrained cemented prosthesis |
|---------------|----------------------------------------------------------------------------------|
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MBL, MEH, LZO, JDI |
Device Description
Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.
Technological Characteristics
This 510(k) was prepared in accordance with the Agency's, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of the mechanical data indicates that the R3 22-36mm XLPE Acetabular Liners are capable of withstanding expected in vivo loading without failure. The following mechanical testing of the R3 XLPE Liners was performed:
- Push-out Testing .
- Torque-to-Failure Testing ●
- Lever-out Testing ●
- Fatigue Testing ●
- Post-Fatigue Push-out Testing ◆
1
A review of this testing has demonstrated 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
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.
The Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Substantial Equivalence Information
The substantial equivalence of the R3 XLPE Liners is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|-----------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Reflection 3 Acetabular System | K061253 | 5/31/06 |
| Smith & Nephew, Inc. | Reflection XLPE Acetabular Liners | K002747 | 12/15/00 |
| Smith & Nephew, Inc. | Reflection XLPE Acetabular Liners | K071160 | 10/5/07 |
| Smith & Nephew, Inc. | R3 36mm XLPE Liners | K092386 | 11/3/09 |
| Smith & Nephew, Inc. | R3 40 and 44mm XLPE Liners | K093363 | 1/26/10 |
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the R3 22-36mm XLPE Acetabular 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 acetabular liners.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Incorporated % Mr. John Connor Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
APR 2 7 2012
Re: K113848
Trade/Device Name: R3 XLPE Acetabular 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: MBL, MEH, LZO, JDI Dated: April 23, 2012 Received: April 24, 2012
Dear Mr. Connor:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. John Connor
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,
Mark N. Melkerson 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):
R3 XLPE Acetabular Liners Device Name:
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, stipped 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.
The Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Prescription Use __ X (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)
Ashish
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K113848 510(k) Number