TOTAL HIP FEMORAL HEADS AND LINERS

K022958 · Smith & Nephew, Inc. · JDI · Oct 2, 2002 · Orthopedic

Device Facts

• Record ID: K022958
• Device Name: TOTAL HIP FEMORAL HEADS AND LINERS
• Applicant: Smith & Nephew, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• 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; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Total Hip Femoral Heads & Liners are designed for single use only and may be used as part of cemented total hip arthroplasty.

Device Story

Total Hip Femoral Heads & Liners are orthopedic implants for total hip arthroplasty. Femoral heads consist of zirconium alloy or alumina ceramic; designed for 12/14 taper connection with titanium or cobalt-chromium femoral components. Liners consist of crosslinked polyethylene; designed for use with titanium acetabular shells. Devices are single-use; implanted by surgeons in clinical settings to replace damaged hip joints. Mechanical and wear testing confirms ability to withstand in vivo loading. Benefits include restoration of hip function and mobility for patients with degenerative or traumatic joint conditions.

Clinical Evidence

Bench testing only. Mechanical and wear test data provided to demonstrate equivalence to predicate devices and ability to withstand in vivo loading.

Technological Characteristics

Materials: zirconium alloy, alumina ceramic, crosslinked polyethylene. Design: femoral heads with 12/14 taper; liners for titanium acetabular shells. Mechanical/wear testing performed to verify performance. No software or electronic components.

Indications for Use

Indicated for individuals undergoing primary or 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, nonunion, femoral neck/trochanteric fractures, femoral osteotomy, Girdlestone resection, fracture dislocation, or deformity) where other treatments have failed.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Sulzer Inter-Op CoCr heads (K993259)
• Osteonics Alumina C-Taper Heads (K003391)
• Sulzer Inter-Op Durasul Acetabular Inserts (K993259 & K002575)
• DePuy Duraloc Acetabular Cup System (K010171)

Reference Devices

• Smith & Nephew crosslinked polyethyelene liners

Submission Summary (Full Text)

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OCT 02 2002

K022958

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## Smith & Nephew, Inc. Summary of Safety and Effectiveness :Total Hip Femoral Heads & Liners

### Contact Person and Address

Date of Summary: September 5, 2002

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedics Division 1450 East Brooks Road Memphis, TN 38116 [phone] Name of Device: Total Hip Femoral Heads & Liners Common Name: Femoral heads and acetabular liners

### Device Classification Name

21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis:Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis: Class II

21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis: Class II

#### Substantial Equivalence Information

The Total Hip Femoral Heads are substantially equivalent to Sulzer Inter-Op CoCr heads (K993259). Osteonics Alumina C-Taper Heads (K003391), and currently marketed heads distributed by Smith & Nephew. The Total Hip Liners are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Inserts (K993259 & K002575), DePuy Duraloc Acetabular Cup System (K010171), and Smith & Nephew crosslinked polyethyelene liners.

#### Device Description

The Total Hip Femoral Heads are zirconium alloy or alumina ceramic devices designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. These heads are to be used with the appropriate sized crosslinked polyethylene Total Hip Liners. Total Hip Liners are to be used with corresponding titanium acetabular shells.

#### Indications for 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; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Total Hip Femoral Heads & Liners are designed for single use only and may be used as part of cemented total hip arthroplasty.

#### Technological & Performance Characteristics:

The Total Hip Femoral Heads and Liners are similar to currently marketed femoral heads and liners. These components share the same intended use, material, and design features of one or more of the above mentioned predicates. A review of the mechanical and wear test data indicated that the Total Hip Femoral Heads and Liners are equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kim P. Kelly Project Manager, Regulatory & Clinical Affairs Smith and Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

OCT 02 2002

#### Re: K022958

Trade/Device Name: Total Hip Femoral Heads and Liners Regulation Number: 21 CFR 888.3350, 888.3353, 888.3358

Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis;

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: Class II Product Code: JDI, LZO, LPH Dated: September 5, 2002 Received: September 6, 2002

Dear Mr. Kelly:

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.

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.

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Page 2 -- Mr. Kim P. Kelly

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" (21 CFR 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,

R. Martin A. McMillan

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

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# K077958

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# Total Hip Femoral Heads & Liners - Indications Statement

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; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

## Concurrence of CDRH, Office of Device Evaluation

Prescription Use

OR
(Per 21 CFR 801.109)

Over-The Counter Use

A. Mula A. Milliman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022958