TOTAL HIP FEMORAL HEAD - 12/14 TAPER

K021673 · Smith & Nephew, Inc. · LZO · Jun 11, 2002 · Orthopedic

Device Facts

• Record ID: K021673
• Device Name: TOTAL HIP FEMORAL HEAD - 12/14 TAPER
• Applicant: Smith & Nephew, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• 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.

Device Story

Total Hip 12/14 Taper Femoral Heads are orthopedic prosthetic components; designed for use with titanium or cobalt chromium alloy femoral stems featuring a 12/14 taper interface. Intended for single-use in primary or revision hip arthroplasty. Device functions as a load-bearing articulation surface for the hip joint. Operated by orthopedic surgeons in a clinical/surgical setting. Mechanical design ensures compatibility with existing femoral components to restore joint function and mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Mechanical test data indicates the device is equivalent to currently marketed devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Femoral heads designed for 12/14 taper interface; compatible with titanium and cobalt chromium alloy femoral components. Single-use. No specific materials or standards provided beyond general alloy references.

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, nonunion, femoral neck/trochanteric fractures, or deformity).

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Reference Devices

• Smith & Nephew CoCr alloy femoral heads
• Smith & Nephew yttria-stabilized zirconia femoral heads

Submission Summary (Full Text)

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# K021673

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Summary of Safety and Effectiveness Smith & Nephew, Inc. Total Hip Femoral Heads, 12/14 taper

## Contact Person and Address

Kim Kelly Senior Clinical and Regulatory Affairs Specialist Smith & Nephew. Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 [phone]

# Device Description

The Total Hip 12/14 Taper Femoral Heads are designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.

#### Device Classification Name

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

#### 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 12/14 Taper Femoral Heads are designed for single use only.

## Mechanical and Clinical Data

A review of the mechanical test data indicated that the Total Hip 12/14 Taper Femoral Heads are equivalent to devices currently on the market and capable of withstanding expected in vivo loading without failure.

## Substantial Equivalence Information

The Total Hip 12/14 Taper Femoral Heads are similar to the femoral heads currently distributed by Smith & Nephew, Inc. All heads are indicated for total hip replacement and are similar to Smith & Nephew CoCr alloy and yttria-stabilized zirconia femoral heads.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 1 2002 .

Ms. Kim P. Kelly, MS Senior Regulatory & Clinical Affairs Specialist Orthopaedic Division Smith & Nephew, Inc. 1450 East Brooks Road Memphis, TN 38116

Re: K021673

Trade/Device Name: Total Hip Femoral Head - 12/14 Taper Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: May 20, 2002 Received: May 21, 2002

Dear Ms. 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

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Page 2 - Ms. Kim 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 imarketed 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 vour 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,

Mark N. Milliman

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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# Total Hip Femoral Heads, 12/14 taper 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

X Prescription Use

OR (Per 21 CFR 801.109)

Over-The Counter Use -------

10f1

R. Mark N. Wilkerson

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

510(k) Number .