SYNERGY CEMENTED HIP STEM

K990369 · Smith & Nephew, Inc. · JDI · Mar 12, 1999 · Orthopedic

Device Facts

• Record ID: K990369
• Device Name: SYNERGY CEMENTED HIP STEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip components are indicated cemented 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 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Synergy Cemented Hip Stems are designed for single use only.

Device Story

Synergy Cemented Hip Stems are prosthetic hip joint components for cemented fixation; manufactured from forged cobalt chrome (CoCr). Designed for use with modular femoral heads (cobalt chrome or ceramic) via 12/14 taper. Intended for single use in primary or revision hip surgery. Implanted by orthopedic surgeons in clinical/hospital settings to replace damaged hip joints. Device restores hip function and mobility in patients with degenerative or traumatic joint conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Forged cobalt chrome (CoCr) per ASTM F799. Design: Nonporous tapered hip stem for cemented use. Interface: 12/14 taper for modular femoral heads. Single-use device.

Indications for Use

Indicated for individuals undergoing primary and revision total hip arthroplasty 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).

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

• Global Taper "Tapered" Hip Stem (Smith & Nephew)
• Zimmer Versys® Hip Stem (Zimmer)
• Wright Perfecta IMC™ Hip Stem (Wright Medical)
• Spectron Extra Small Straight Femoral Component (Smith & Nephew)
• DePuy AML® Hip Stem (DePuy)

Submission Summary (Full Text)

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3/12/99

K99 0369

# 510(k) Summary

Smith & Nephew, Inc. 1450 Brooks Road, Memphis, TN 38116 901-399-5363 Neal Defibaugh February 23, 1999 Synergy Cemented Hip Stems Prosthetic Hip Joint - Nonporous Tapered Hip Stem

21 CFR 888.3350 hip joint metal/polymer/metal semiconstrained cemented prosthesis-Class II, 87JDI

# Substantially Equivalent Legally Marketed Devices

Submitter's name:

Contact person:

Submitter's address:

Date summary prepared:

Common or usual name:

Classification name:

Submitter's telephone number:

Trade or proprietary device name:

- Global Taper "Tapered" Hip Stem Smith & Nephew .
- Zimmer Versys® Hip Stem Zimmer ●
- Wright Perfecta IMC™ Hip Stem Wright Medical .
- Spectron Extra Small Straight Femoral Component Smith & Nephew .
- DePuy AML® Hip Stem DePuy .

#### Device Description

The Synergy Cemented Hip Stems are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.

## Device Intended Use

Total hip components are indicated cemented 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 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

The Synergy Cemented Hip Stems are designed for single use only.

#### Technological characteristics:

The Synergy Cemented Hip 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 the Synergy Cemented Hip Stems and have the same technological characteristics.

#### Performance characteristics:

Data indicate that the Synergy Cemented Hip Stems are substantially equivalent to legally marketed devices.

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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 features a stylized depiction of an eagle or bird, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Mr. Neal Defibaugh Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

K990369 Re: Synergy Cemented Hip Stems Trade Name: Requlatory Class: II Product Code: JDI February 5, 1999 Dated: February 8, 1999 Received:

### Dear Mr. Defibaugh:

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 The general controls provisions of the Act 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. ਸੀ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.

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# Page 2 - Mr. Neal Defibaugh

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.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witten, Ph.D. M.D.

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

Enclosure

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# Indications Statement Synergy Cemented Hip Stems

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Total hip components are indicated for cemented 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 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 head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Pecellfo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990631