R3 XLPE LINERS

K113848 · Smith & Nephew, Inc. · MBL · Apr 27, 2012 · Orthopedic

Device Facts

• Record ID: K113848
• Device Name: R3 XLPE LINERS
• Applicant: Smith & Nephew, Inc.
• Product Code: MBL · Orthopedic
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Traditional
• 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

Acetabular liner component for hip arthroplasty; modification to existing R3 XLPE liners. Device features four added vents in locking detail to facilitate fluid egress during impaction; minimizes seating difficulty. Used in orthopedic surgery; implanted by surgeons. Mechanical design ensures stability under in vivo loading. Benefits include improved surgical handling and secure fixation within acetabular shell.

Clinical Evidence

Bench testing only. Mechanical testing performed per FDA Guidance Document for Testing Acetabular Cup Prostheses (May 1995) included push-out, torque-to-failure, lever-out, fatigue, and post-fatigue push-out testing. Results demonstrate the device withstands expected in vivo loading without failure. No clinical data required.

Technological Characteristics

Acetabular liner; XLPE (cross-linked polyethylene). Features four vents in locking detail for fluid egress. Cementless design. Mechanical testing performed per FDA 1995 guidance. No software or electronic components.

Indications for Use

Indicated for primary and revision hip surgery patients with 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 (K061253)
• Reflection XLPE Acetabular Liners (K002747)
• Reflection XLPE Acetabular Liners (K071160)
• R3 36mm XLPE Liners (K092386)
• R3 40 and 44mm XLPE Liners (K093363)

Submission Summary (Full Text)

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K113848

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 [phone] F [phone]

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-<br>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 ◆

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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<br>Number | Clearance<br>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.

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# 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

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### 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 [phone] or [phone] 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

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# 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