MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

K013658 · Smith & Nephew, Inc. · LPH · Dec 5, 2001 · Orthopedic

Device Facts

• Record ID: K013658
• Device Name: MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 5, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Reflection® Cross-linked UHMWPE Acetabular Components are designed for single use only.

Device Story

Reflection® Cross-linked UHMWPE Acetabular Components are orthopedic implants for total hip arthroplasty. Device consists of cross-linked ultra-high molecular weight polyethylene (UHMWPE) acetabular liners/cups designed for articulation against zirconia ceramic femoral heads. Intended for single use in primary or revision hip surgery. Device functions as a bearing surface to restore hip joint function in patients with degenerative or traumatic hip conditions. Substantial equivalence is claimed to predicate devices cleared under K002747. Clinical benefit derived from reduced wear rates and particle generation compared to conventional UHMWPE and other cross-linked configurations. No software or active electronic components involved.

Clinical Evidence

Bench testing only. Performance characteristics verified against draft Guidance Document for Testing Acetabular Cup Prostheses (05-01-95). Wear claims supported by comparative particle generation data: 84% reduction vs. conventional UHMWPE/CoCr, 79% reduction vs. conventional UHMWPE/zirconia, and 41% reduction vs. cross-linked UHMWPE/CoCr.

Technological Characteristics

Material: 10 Mrad cross-linked UHMWPE. Components: Acetabular liners/cups for hip arthroplasty. Interface: Articulation against zirconia ceramic femoral heads. Design: Identical to predicate K002747. No active energy source or software.

Indications for Use

Indicated for individuals undergoing primary and revision hip surgery due to trauma, inflammatory joint disease (e.g., rheumatoid arthritis), or noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, osteomyelitis, non-union, femoral neck/trochanteric fractures, femoral osteotomy, Girdlestone resection, fracture dislocation, or deformity).

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® Cross-linked UHMWPE Acetabular Components (K002747)
• Zirconia Ceramic Femoral Heads (K002747)

Submission Summary (Full Text)

{0}------------------------------------------------

Kol3657

DEC 0 5 2001

# 510(K) SUMMARY

Page 1 of 2

Reflection® Cross-linked UHMWPE Acetabular Components

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Mour Do Rosety and Effectiveness for the use of the Reflection® Cross-linked UHMWPE Acetabular Components.

Submitter's name: Submitter's address:

Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary name:

Common or usual name:

Classification name:

Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 901-399-6487 David Henley November 5, 2001 Reflection® Cross-linked UHMWPE Acetabular Components Polyethylene Acetabular Components

21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, metal/polymer, Cemented - Class II

21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained, metal/polymer, Uncemented -Class II

Device Product Code and Panel Code:

Orthopedics/87/LPH, JDI

## Substantially Equivalent Legally Marketed Devices

- Reflection® Cross-linked UHMWPE Acetabular Components Smith & Nephew, Inc. .
- Zirconia Ceramic Femoral Heads Smith & Nephew, Inc. .

## Device Description:

The intended use, type of interface, and design features of the Reflection® Cross-linked UHMWPE Acetabular Components are identical to Smith and Nephew, Inc. predicate counterparts cleared for market under K002747.

- This Special 510(k) premarket notification is requesting approval for use of Reflection® 10 Mrad . Cross-Linked UHMWPE Acetabular Components with zirconia ceramic femoral heads.
## Device Intended Use:

Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis;

CONFIDENTIAL

{1}------------------------------------------------

traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Reflection® Cross-linked UHMWPE Acetabular Components are designed for single use only.

## Technological Characteristics:

The polyethylene devices that are the subject of this Special 510(k) premarket notification are identical to Smith and Nephew, Inc. predicate device counterparts cleared for market under K002747. Thus, the intended use, material, and design features of Reflection® Cross-linked UHMWPE Acetabular Components are identical to devices approved under K002747. There have been no modifications to the manufacturing process for the Cross-Linked UHMWPE material used to manufacture these devices. The safety and effectiveness for Smith and Nephew's Reflection Cross-Linked UHMWPE material in acetabular liner/cup applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data, and testing results provided in this Special 510(k) premarket notification.

## Performance characteristics:

Test data indicate that the Reflection® Cross-linked UHMWPE Acetabular Components meet the requirements of draft Guidance Document for Testing Acetabular Cup Prostheses, dated 05-01-95. The subject devices are identical to predicate devices cleared under K002747.

## Wear claims:

The following marketing claims will be made for the Reflection® Cross-linked UHMWPE Acetabular Components articulating against zirconia ceramic femoral heads:

- 1. No detectable wear as measured gravimetrically.
- 2. Generation of 84% fewer particles compare to conventional, non-irradiated UHMWPE used against CoCr femoral heads.
- 3. Generation of 79% fewer particles compare to conventional, non-irradiated UHMWPE used against zirconia ceramic femoral heads.
- 4. Generation of 41% fewer particles compared to Cross-Linked UHMWPE used against CoCr femoral heads.

{2}------------------------------------------------

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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2001

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith + Nephew, Inc. Orthopaedics Division 1450 Brooks Rd., Memphis, Tennessee 38116

Re: K013658

Trade Name: Reflection Cross-Linked UHMWPE Acetabular Components Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis and Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH and JDI Dated: November 5, 2001 Received: November 6, 2001

Dear Mr. Henley

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

Page 2 -- Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

b. Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications Statement

K013658
page 1 of 1

Reflection® Cross-linked UHMWPE Acetabular Components

Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Mark N Milken

eral. Pestorative

510(k) N"y"