SMITH & NEPHEW MIS HIP STEM WITH STIKTITE

K080625 · Smith & Nephew, Inc. · LPH · May 8, 2008 · Orthopedic

Device Facts

• Record ID: K080625
• Device Name: SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: May 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip components are indicated for uncemented use 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 osteomyelitits 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. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.

Device Story

MIS Hip Stem is a straight, tapered, proximally loading femoral stem; designed to match femoral geometry. Available in sizes 1-9 with modular neck options. Manufactured from titanium alloy (Ti-6Al-4V) with cobalt chrome necks; proximal surface features Stiktite porous coating for biological fixation. Intended for uncemented implantation in primary or revision total hip arthroplasty. Device provides structural support for hip joint reconstruction; restores joint function in patients with degenerative or traumatic hip conditions. Used by orthopedic surgeons in clinical/surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Straight, tapered, proximally loading femoral stem. Materials: Titanium alloy (Ti-6Al-4V) stem, Cobalt Chrome neck. Surface: Stiktite porous coating. Fixation: Uncemented. Sizes: 1-9. Modular design.

Indications for Use

Indicated for primary and revision hip surgery in patients with 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, femoral osteotomy, Girdlestone resection, fracture dislocation, or deformity).

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Submission Summary (Full Text)

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KD80625 (pg 111)

MAY - 8 ZUUG

# Smith & Nephew, Inc. Summary of Safety and Effectiveness MIS Hip Stem

#### Contact Person and Address

Date of Summary: 03/4/2008

Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: Smith & Nephew MIS Hip Stem with Stiktite Common Name: MIS Hip Stem

### Device Description

The Smith & Nephew MIS Stem is a straight, tapered, proximally loading stem designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 1 through 9 and have modular neck options to address patient anatomy. The stems are manufactured from titanium alloy (Ti-6Al-4VI and the necks are manufactured from Cobalt Chrome. Each femoral stem is proximally coated with Smith & Nephew's Stiktite porous coating.

#### Device Classification

21 CFR 888.3358 Hip joint metal semi-constrained porous-coated Uncemented prosthesis – Class II

### Indications for Use

Total hip components are indicated for uncemented use 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 osteomyelitits 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. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.

#### Substantial Equivalence Information

The overall design of the Smith & Nephew MIS Hip Stem is substantially equivalent to previously cleared devices listed below.

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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 consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA". Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a ribbon-like object in its talons. The eagle is depicted in a simple, black and white design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. Rishi Sinha Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

MAY - 8 2008

Re: K080625

> Trade/Device Name: MIS Hip Stem with Stiktite Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: April 10, 2008 Received: April 11, 2008

Dear Mr. Sinha:

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. Rishi Sinha

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Miller

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

Enclosure

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Indications for Use

#### 510(k) Number (if known): KD80625 (pg 111)

Device Name: MIS Hip Stem with Stiktite

## Indications for Use:

Total hip components are indicated for Uncemented use 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 osteomyelitits 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. Smith & Nephew MIS Hip Stem components are intended for single use only and are to be implanted without bone cement.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilh Ogle for nxm

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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**510(k) Number** K080625