SYNERGY HA COATED POROUS FEMORAL STEMS

K002996 · Smith & Nephew, Inc. · MEH · Dec 11, 2000 · Orthopedic

Device Facts

• Record ID: K002996
• Device Name: SYNERGY HA COATED POROUS FEMORAL STEMS
• Applicant: Smith & Nephew, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: Dec 11, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip components are indicated uncemented use only in 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 non-inflammatory 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Synergy HA Coated Porous Femoral Stem is designed uncemented use only and for single use only,

Device Story

Synergy HA Coated Porous Femoral Stems are prosthetic hip joint components for uncemented fixation. Device consists of titanium alloy (Ti-6Al-4V) femoral stem with porous titanium bead coating. Designed for use with modular cobalt chrome or ceramic femoral heads via 12/14 taper. Intended for implantation by orthopedic surgeons in clinical settings during primary or revision total hip arthroplasty. Provides structural replacement for damaged femoral head/neck; promotes biological fixation via porous coating. Single-use device.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V, ASTM F1472). Porous coating: Titanium bead material (Ti-6Al-4V, ASTM F67, Grade 2, mesh size -45/+60). Connection: 12/14 taper for modular femoral heads. Fixation: Uncemented, porous-coated. Sterilization: Not specified.

Indications for Use

Indicated for primary and revision hip surgery in patients with hip damage due to trauma, inflammatory joint disease (e.g., rheumatoid arthritis), or non-inflammatory 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). For uncemented, single use only.

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.

Predicate Devices

• Global Taper Tapered (Synergy) HA Hip Stem Smith & Nephew
• Secur-Fit® HA Hip Stem Osteonics® Corp.
• Omnifit® HA Hip Stem Osteonics® Corp.
• Meridian® ST/PA Femoral Stem Howmedica Corp.
• APR Porous HA Hip System Sulzer Orthopedics, Inc.

Submission Summary (Full Text)

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

Koo2996

## 510(k) Summarv Synergy HA Coated Porous Femoral Stems

Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary device name: Common or usual name:

Smith & Nephew, Inc. 1450 Brooks Road. Memphis. TN 38116 901-399-6487 David Henley September 22, 2000 Synergy HA Coated Porous Femoral Stems Prosthetic Hip Joint - HA Coated Porous Femoral Stem

Classification name:

21 CFR 888.3358 hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis-Class II 87LPH

## Substantially Equivalent Legally Marketed Devices

- Global Taper Tapered (Synergy) HA Hip Stem Smith & Nephew .
- Secur-Fit® HA Hip Stem Osteonics® Corp. .
- t Omnifit® HA Hip Stem - Osteonics® Corp.
- Meridian® ST/PA Femoral Stem - Howmedica Corp.
- . APR Porous HA Hip System - Sulzer Orthopedics, Inc.

#### Device Description

Synergy HA Coated Porous Femoral Stems are manufactured from titanium material (Ti-6A1-4V, ASTM F1472) and are porous coated with bead material manufactured from titanium material (Ti-6AI-4V, ASTM F67, Grade 2, with a mesh size of -- 45/+60. These stems are designed for use with existing Smith & Nephew cobalt chrome or ceramic modular femoral heads with a 12/14 taper.

#### Device Intended Use

Total hip components are indicated uncemented use only in 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 non-inflammatory 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

The Synergy HA Coated Porous Femoral Stem is designed uncemented use only and for single use only,

## Technological characteristics:

Synergy HA Coated Porous Femoral Stems are similar to the legally marketed devices listed above. All of these devices are indicated for total hip replacement, are similar in design to Synergy HA Coated Porous Femoral Stems, and have the same technological characteristics.

## Performance characteristics:

Data indicate that Synergy HA Coated Porous Femoral Stems are substantially equivalent to identified legally marketed devices.

SynHAPor510kSum

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 a stylized eagle-like symbol, depicted with three curved lines forming the body and wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 11 2000

Mr. David Henley Clinical/regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K002996

Trade Name: Synergy HA Coated Porous Femoral Stems Regulatory Class: II Product Code: MEH Dated: September 22, 2000 Received: September 25, 2000

Dear Mr. Henley:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS).for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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

## Page 2 - Mr. David Henley

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

La Mark N. Mulkerson

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

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

Koo2996

# Indications Statement Synergy HA Coated Porous Femoral Stems

Total hip components are indicated for uncemented use only in individuals undergoing primary and revision survery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or non-inflammatory degenerative joint disease (NDJD) 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Mark N. Milkerss

(Division Sign-Off) Division of General Restorative Devices 510(k) Number.