(152 days)
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.
Subject of this Abbreviated Premarket Notification are R3 XLPE Acetabular Liner line additions in an anteverted liner option. Anteverted liners modify the face opening of the acetabular liner component. The subject devices are intended to be used in conjunction with existing R3 Acetabular Shells, and they are intended to articulate against appropriately sized, existing Smith & Nephew femoral heads. They are manufactured from XLPE material and will initially be offered in inner diameters of 32 and 36mm and outer diameters of 48-72/74mm.
R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K070756 and K092386 in liner options of 0°,0° lateralized +4mm, 20°, and 20° lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar to the R3 XLPE 20° lateralized +4mm Acetabular Liners cleared under K070756. The differences are described below.
- The face of the acetabular liner has been changed by 20° to re-orient the opening face of . the liner relative to a given shell orientation when necessary
- Four vents have been added to the locking detail of the subject R3 XLPE Anteverted . Liners.
This document describes the R3 XLPE Anteverted Liners, a medical device. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (as assessed against Guidance Document) |
|---|---|
| Range of Motion | Evaluated; no new issues related to safety or effectiveness |
| Attachment Loads | Evaluated; no new issues related to safety or effectiveness |
| Fatigue Properties | Evaluated; no new issues related to safety or effectiveness |
| Cyclic Wear | Evaluated; no new issues related to safety or effectiveness |
| Degradation | Evaluated; no new issues related to safety or effectiveness |
| Corrosion | Evaluated; no new issues related to safety or effectiveness |
Study that Proves the Device Meets Acceptance Criteria:
The device's performance was evaluated through a series of tests conducted in accordance with the guidance titled "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. A review of these tests demonstrated that there were no new issues related to the safety or effectiveness of the R3 XLPE Anteverted Liners. This evaluation compared the new device's performance against established criteria and the performance of previously cleared predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the performance tests (e.g., number of liners tested for fatigue, wear, etc.). The data provenance is laboratory testing in accordance with an FDA guidance document, rather than clinical data from human subjects. Therefore, details like country of origin or retrospective/prospective are not applicable in the context of this device's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for this device's performance was established through engineering and materials testing standards outlined in the "Guidance Document for Testing Acetabular Cup Prostheses," not through expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As the evaluation was based on standardized physical and mechanical tests, there was no need for an adjudication method among human reviewers. The results would be objectively measured against predefined criteria in the guidance document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study involving human readers and AI is irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance was engineering and materials testing standards and criteria as detailed in the "Guidance Document for Testing Acetabular Cup Prostheses." This includes objective measurements of properties like range of motion, attachment loads, fatigue life, wear rates, degradation, and corrosion resistance.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and evaluation as described here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device evaluation.
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Summary of Safety and Effectiveness R3 XLPE Anteverted Liners Smith & Nephew, Inc.
KI02370
Date of Summary: January 18, 2011
Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340
JAN 19 2011
Name of Device: R3 XLPE Anteverted Liners
Common Name: Acetabular System
Device Classification Name and Reference: 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis
Device Class: Class II
Panel Code: Orthopaedics/87 MBL
Device Description
Subiect of this Abbreviated Premarket Notification are R3 XLPE Acetabular Liner line additions in an anteverted liner option. Anteverted liners modify the face opening of the acetabular liner component. The subject devices are intended to be used in conjunction with existing R3 Acetabular Shells, and they are intended to articulate against appropriately sized, existing Smith & Nephew femoral heads. They are manufactured from XLPE material and will initially be offered in inner diameters of 32 and 36mm and outer diameters of 48-72/74mm.
R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K070756 and K092386 in liner options of 0°,0° lateralized +4mm, 20°, and 20° lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar to the R3 XLPE 20° lateralized +4mm Acetabular Liners cleared under K070756. The differences are described below.
- The face of the acetabular liner has been changed by 20° to re-orient the opening face of . the liner relative to a given shell orientation when necessary
- Four vents have been added to the locking detail of the subject R3 XLPE Anteverted . Liners.
Similar face changing liners have also been cleared for market by DePuy Orthopaedics, Inc. under premarket notification K062148.
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.
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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.
Performance Data
Performance testing has been conducted for the subject devices in accordance with the guidance titled "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995. Range of motion, attachment loads, fatigue properties, and cyclic wear, degradation, and corrsion have been evaluated. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The subject R3 XLPE Anteverted Liners are substantially equivalent to the predicate devices listed in the table below. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate acetabular liners.
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew, Inc. | Reflection 3 Acetabular System | K070756 | 6/6/07 |
| Smith & Nephew, Inc. | R3 Multi-Hole Shells and 36mm XLPEAcetabular Liners | K092386 | 11/3/09 |
| Smith & Nephew, Inc. | CoCr and Oxinium Femoral Heads and R3XLPE Liners | K093363 | 1/26/10 |
| DePuy Orthopaedics, Inc. | DePuy Pinnacle AltrX Acetabular CupLiner | K062148 | 10/24/06 |
Conclusion
As previously noted, this Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the R3 XLPE Anteverted Liners. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to acetabular liners currently marketed under K070756, K092386, K093363, and K062148.
Page 262
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
JAN 1 9 201 Re: K102370 Trade/Device Name: R3 XLPE Anteverted 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 Dated: January 12, 2011 Received: January 14, 20111
Dear Ms. Bevill:
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
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Page 2 - Ms. Megan Bevill
device-related adverse events) (2) CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Az B. n
fr
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K102370
Device Name: R3 XLPE Anteverted Liners
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, 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 × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mulkerson
(Division Sign-Off) Division of Surgical, Ort Division of Solo
Division of Sestorative Devices
510(k) Number K102370
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§ 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.