SMITH & NEPHEW SMF HIP STEM

K123012 · Smith & Nephew, Inc. · LPH · Oct 24, 2012 · Orthopedic

Device Facts

• Record ID: K123012
• Device Name: SMITH & NEPHEW SMF HIP STEM
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hip components are 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. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; 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. Smith & Nephew SMF® Hip Stem components are intended for single use only and are to be implanted without bone cement.

Device Story

Smith & Nephew SMF Hip Stem is a straight, tapered, proximally loaded femoral stem; monoblock design; fixed 12/14 neck taper for femoral head attachment. Manufactured from Ti-6Al-4V titanium alloy; features Stiktite porous coating for proximal fixation; distal tip includes glass bead finish. Intended for uncemented implantation in primary or revision hip arthroplasty. Used by orthopedic surgeons in clinical/OR settings. Provides structural support for hip joint reconstruction; restores joint function; alleviates pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Fatigue strength testing conducted per FDA guidance documents for orthopaedic implants with modified metallic surfaces, non-articulating modular components, and femoral stem prostheses.

Technological Characteristics

Material: Ti-6Al-4V titanium alloy. Design: Straight, tapered, proximally loaded monoblock femoral stem. Features: Stiktite porous coating, 12/14 neck taper, medial grit-blasted finish, glass bead distal tip. Sizes: 1-9. Configuration: Standard and high offset options. Sterilization: Not specified. Connectivity: None (mechanical implant).

Indications for Use

Indicated for primary and revision hip surgery patients with 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, secondary arthritis, congenital dysplasia), nonunion, femoral neck/trochanteric fractures, endoprosthesis, femoral osteotomy, Girdlestone resection, fracture-dislocation, or deformity correction.

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

• SMF Hip Stems (K103256)

Submission Summary (Full Text)

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OCT 24 2012

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

Date of Summary: 9/27/2012

Contact Person and Address

Natalie P. Williams Senior Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 [phone]

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 SMP Hip Stem is a straight, tapered, proximally loaded stem designed to match the geometry of the femur. The subject monoblock SMF° femoral stem line additions are offered in sizes 1 - 9. 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 SMF® monoblock femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.

#### Intended Use

Hip components are 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.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; 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.

Smith & Nephew SMP 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:

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- 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.

### Substantial Equivalence Information

The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew SMF° Hip Stem line additions are substantially equivalent to the SMP Hip Stems cleared in premarket notification K103256. 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 SMF® Hip Stem<br>Line Additions | Predicate SMF® Hip Stems<br>(K103256) |
|--------------------------------------------------|-----------------------------------------|---------------------------------------|
| Similar Indications<br>for Use | ✓ | ✓ |
| Size Offering | 1 - 9 | -1 and 0 |
| Stem Material | Ti-6Al-4V | Ti-6Al-4V |
| Tapered Stem<br>Geometry | ✓ | ✓ |
| Medial Grit-Blasted<br>Surface Finish | ✓ | ✓ |
| Proximal Porous<br>Coating | ✓ | ✓ |
| Glass Bead Distal Tip | ✓ | ✓ |
| Fixed Neck | ✓ | ✓ |
| Neck Taper | 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 Special 510(k) Premarket Notification is being submitted to request clearance for the sizes 1 - 9 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 the femoral stem components currently marketed under K103256.

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Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

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

OCT 24 2012

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

Re: K123012

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: September 27, 2012

Received: September 28, 2012

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Natalie P. Williams

CFR Part 807); labeling (21 CFR Part 801); medical device 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,

fee Duth lind.

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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K1230126pg1117

# 510(k) Number (if known): K123012

Device Name: Smith & Nephew SMF Hip Stem

#### Indications for Use:

Hip components are 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.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; 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.

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)

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)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

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| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | k123012 |