R3 XLPE ANTEVERTED LINERS

K102370 · Smith & Nephew, Inc. · MBL · Jan 19, 2011 · Orthopedic

Device Facts

• Record ID: K102370
• Device Name: R3 XLPE ANTEVERTED LINERS
• Applicant: Smith & Nephew, Inc.
• Product Code: MBL · Orthopedic
• Decision Date: Jan 19, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

R3 XLPE Anteverted Liners are acetabular liner components for hip arthroplasty; used with existing R3 Acetabular Shells and Smith & Nephew femoral heads. Device modifies face opening by 20° to re-orient liner relative to shell; features four added vents in locking detail. Manufactured from XLPE; offered in 32/36mm inner diameters and 48-72/74mm outer diameters. Intended for cementless use in primary/revision surgery. Operated by orthopedic surgeons in clinical/OR settings. Provides stable articulation surface for femoral head; benefits patients by restoring hip function and correcting anatomical orientation.

Clinical Evidence

Bench testing only. Evaluated per FDA guidance 'Guidance Document for Testing Acetabular Cup Prostheses' (May 1995). Testing included range of motion, attachment loads, fatigue properties, cyclic wear, degradation, and corrosion. No clinical data required.

Technological Characteristics

Material: XLPE. Form factor: Acetabular liner with 20° anteverted face and four locking detail vents. Dimensions: 32/36mm ID, 48-72/74mm OD. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for primary and revision hip surgery patients with hip damage due to trauma, NIDJD (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, secondary arthritis, congenital dysplasia), nonunion, femoral neck/trochanteric fractures, endoprosthesis, femoral osteotomy, Girdlestone resection, fracture-dislocation, or deformity correction.

Regulatory Classification

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.

Predicate Devices

• Reflection 3 Acetabular System (K070756)
• R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners (K092386)
• CoCr and Oxinium Femoral Heads and R3 XLPE Liners (K093363)
• DePuy Pinnacle AltrX Acetabular Cup Liner (K062148)

Submission Summary (Full Text)

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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 [phone]

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 | Submission<br>Number | Clearance<br>Date |
|--------------------------|---------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Reflection 3 Acetabular System | K070756 | 6/6/07 |
| Smith & Nephew, Inc. | R3 Multi-Hole Shells and 36mm XLPE<br>Acetabular Liners | K092386 | 11/3/09 |
| Smith & Nephew, Inc. | CoCr and Oxinium Femoral Heads and R3<br>XLPE Liners | K093363 | 1/26/10 |
| DePuy Orthopaedics, Inc. | DePuy Pinnacle AltrX Acetabular Cup<br>Liner | 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.

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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 [phone] or [phone] 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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