SYNERGY HIP SYSTEM

K061066 · Smith & Nephew, Inc. · LZO · Jul 14, 2006 · Orthopedic

Device Facts

• Record ID: K061066
• Device Name: SYNERGY HIP SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergy Hip System is 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. The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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 Synergy Hip System is intended for single use only.

Device Story

Synergy Hip System is a hip joint prosthesis consisting of femoral components and acetabular liners. Device incorporates tantalum markers to enable radiostereometric analysis (RSA) for monitoring implant migration or movement via radiographs. Intended for use by surgeons in clinical settings for primary or revision hip arthroplasty. System provides structural replacement for damaged hip joints, facilitating rehabilitation and correction of deformities. Tantalum markers serve as radiographic reference points, allowing clinicians to assess long-term implant stability post-operatively. Device is single-use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Hip joint prosthesis components (femoral and acetabular) featuring integrated tantalum markers. Tantalum markers function as radiographic contrast agents for post-operative monitoring. System is designed for cemented or uncemented application. Materials and design are consistent with previously cleared Smith & Nephew hip systems.

Indications for Use

Indicated for patients requiring primary or revision hip surgery due to trauma, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), or proximal femur fractures/nonunion. Contraindicated in patients with active infection (caution advised for remote osteomyelitis).

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

• Smith & Nephew Synergy Global Taper Hip System (K963509, K991485, K002996)
• Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component (K002747)
• Biomet Tantalum Bead, Radiographic Marker (K010348)
• Encore Orthopedics Radiographic Marker (K011856)

Submission Summary (Full Text)

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

JUL 1 4 2006

# 510(k) Summary Synergy Hip System

| Submitter's Name: | Smith & Nephew, Inc., Orthopaedics |
|-----------------------------------|-------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's Telephone Number: | 901-399-6670 |
| Contact Person: | John Reabe |
| Date Summary Prepared: | April 7, 2006 |
| Trade or Proprietary Device Name: | Synergy Hip System |
| Common or Usual Name: | Hip joint prosthesis |
| Classification Name: | |
| | 21 CFR 888.3350, |
| | Hip Joint metal/polymer semi-constrained cemented<br>or uncemented prosthesis |
| | 21 CFR 888.3353, |
| | Hip Joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis |
| | 21 CFR 888.3358, |
| | Hip Joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis |
| | 21 CFR 787.4300, |
| | Implantable Clip |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87/LPH, MEH, JDI, LZO<br>General and Plastic Surgery/79/NEL, EZP |

#### Device Description

The Synergy Hip System includes Synergy Hip System Femoral Components with tantalum markers and acetabular component liners with tantalum markers. The addition of tantalum markers is the only change between the predicate devices and the devices included in this submission. The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs.

### Intended Use

The Synergy Hip System is 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.

The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are

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

unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Synergy Hip System is intended for single use only.

## Substantial Equivalence

The intended use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component (K002747), Biomet Tantalum Bead, Radiographic Marker (K010348) and Encore Orthopedics Radiographic Marker (K011856).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 2006

Mr. John Reabe Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K061066

> Trade/Device Name: Synergy Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Codes: LZO, LPH, JDI, MEH, NEU, FZP Dated: June 22, 2006 Received: June 23, 2006

Dear Mr. Reabe:

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

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

Page 2 - Mr. John Reabe

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Aarlene Mueller

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# INDICATIONS FOR USE

510(k) Number (if known): KO61066

Device Name: Synergy Hip System

## Indications for Use:

The Synergy Hip System is 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.

The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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; fracturedislocation of the hip; and correction of deformity.

The Synergy Hip System is intended for single use only.

Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

neral. Restorative. and Neurological Devices

510(k) Number K061066