SMITH & NEPHEW SMF HIP STEM

K103256 · Smith & Nephew, Inc. · LPH · Jan 31, 2011 · Orthopedic

Device Facts

• Record ID: K103256
• Device Name: SMITH & NEPHEW SMF HIP STEM
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 31, 2011
• Decision: SESE
• Submission Type: Abbreviated
• 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 (NID) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

Device Story

The Smith & Nephew SMF Hip Stem is a straight, tapered, proximally loaded femoral stem prosthesis designed for uncemented total hip arthroplasty. It features a fixed, non-modular neck with a 12/14 taper to accommodate standard Smith & Nephew femoral heads. The device is manufactured from titanium alloy (Ti-6Al-4V) and includes a proximal porous coating (Stiktite) to facilitate bone apposition. It is intended for single-use implantation by orthopedic surgeons in clinical settings. The device provides structural support for the hip joint in patients with degenerative or traumatic hip conditions. By replacing the damaged femoral head and neck, the stem aims to restore joint function and mobility. The subject device represents size additions (-1 and 0) to the existing SMF product line.

Clinical Evidence

Bench testing only. Fatigue strength testing was conducted in accordance with FDA guidance documents for orthopaedic implants with modified metallic surfaces and non-articulating modular components. No clinical data was required or provided.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Surface: Proximal Stiktite porous coating, medial grit-blasted finish, glass bead distal tip. Geometry: Straight, tapered, proximally loaded. Neck: Fixed, 12/14 taper, standard and high offset options. Energy source: None (mechanical implant). Sterilization: Not specified.

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, diastrophic variant, nonunion, femoral neck/trochanteric fractures, femoral osteotomy, Girdlestone resection, fracture dislocation, or deformity correction) where other treatments have failed.

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.

Predicate Devices

• S&N SMF Hip Stem with Stiktite (K080625)
• S&N Anthology Stem (K052792)

Submission Summary (Full Text)

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K103256 (pg 1/2)

JAN 3 1 2011

Smith & Nephew, Inc. Summary of Safety and Effectiveness SMF® Hip Stem Line Additions

### Date of Summary: 11/02/2010

Contact Person and Address Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 1901/399-5161

Name of Device: Smith & Nephew SMF® Hip Stem Common Name: Hip Stem Device Classification Name and Reference: 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 LPH

#### Device Description

The Smith & Nephew SMF® Stem, previously marketed by Smith & Nephew as the MIS Hip Stem, is a straight, tapered, proximally loaded stem designed to match the geometry of the subject monobloc SMP femoral stem line additions are offered in sizes -1 and 0. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMP monobloc femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.

#### 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 (NID) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

#### Performance Data

Performance testing has been conducted for the subject devices in accordance with the following guidance documents:

- Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant . Components dated May 1995
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007 .

Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.

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## Substantial Equivalence Information

The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew SMP Hip Stem line additions are substantially equivalent to the SMP Hip Stems cleared in premarket notification K080625 and the Anthology Hip Stems cleared via K052792. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices.

| Feature | Subject Size -1 and 0<br>SMF © Hip Stems with<br>Stiktite | S&N SMF ©<br>Hip Stem with Stiktite<br>(K080625) | S&N Anthology<br>Stem (K052792) |
|--------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------|
| Similar Indications<br>for Use | ✓ | ✓ | ✓ |
| Size Offering | -1 and 0 | 1 - 9 | 1-14 |
| Stem Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Tapered Stem<br>Geometry | ✓ | ✓ | ✓ |
| Medial Grit-Blasted<br>Surface Finish | ✓ | ✓ | ✓ |
| Proximal Porous<br>Coating | ✓ | ✓ | ✓ |
| Glass Bead Distal Tip | ✓ | ✓ | ✓ |
| Neck Options | | | |
| Fixed or<br>Modular Neck | Fixed | Modular | Fixed |
| Neck Taper | 12/14 | 12/14 | 12/14 |
| Standard and High<br>Offset Options<br>Available | ✓ | ✓ | ✓ |
| Polished Neck Area | ✓ | ✓ | ✓ |

Table 1: Comparison of Size -1 and 0 Femoral Stems to Predicate Device

### Conclusion

This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the size -1 and 0 SMF° Hip Stem line addition components. Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to femoral stem components currently marketed under K080625 and K052792.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Natalie P. Williams Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116

JAN 3 1 2011

Re: K103256

Trade/Device Name: Smith & Nephew SMF Hip Stem 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: November 2, 2010 Received: November 3, 2010

Dear Ms. Williams:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ` may be subject to 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

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## Page - 2 - Ms. Natalie P. Williams

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

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

Enclosure

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## Indications for Use

# 510(k) Number (if known): K (03256 (rg 1/1)

Device Name: Smith & Nephew SMF Hip Stem

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; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over - The - Counter Use (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)

M. Mikkerson

(Division Division of Surgical, Orthopedic, and Restorative Device

510(k) Number K103256

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