SMITH & NEPHEW OXINIUM DH FEMORAL HEADS

K081566 · Smith & Nephew, Inc. · LPH · Aug 21, 2008 · Orthopedic

Device Facts

• Record ID: K081566
• Device Name: SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Aug 21, 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 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. Smith & Nephew Oxinium DH femoral heads are for single use only.

Device Story

Oxinium DH femoral heads are orthopedic implants designed for use in total hip arthroplasty; they feature a 12/14 taper for modular connection to existing Smith & Nephew hip stems. The device articulates against acetabular shell and liner constructs. Used in clinical settings by orthopedic surgeons during primary or revision hip surgery; the device replaces damaged femoral heads to restore joint function and mobility. Mechanical testing confirms the device withstands in vivo loading equivalent to predicate devices.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing results indicate the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Oxinium (oxidized zirconium) femoral head; 12/14 taper interface; modular design for use with Smith & Nephew hip stems and acetabular components. Single-use implant.

Indications for Use

Indicated for primary and revision hip surgery in patients with hip damage 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, remote osteomyelitis, 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.

Predicate Devices

• Total Hip 12/14 Taper Femoral Heads (K021673)
• Oxinium femoral heads (K022958)

Submission Summary (Full Text)

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K081566

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510(k) Summary of Safety and Effectiveness Smith & Nephew Oxinium DH Femoral Heads

AUG 2 1 2008

## Contact Person and Address

Date of Summary: July 21, 2008

Jason Sells Project Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 [phone]

Name of Device: Smith & Nephew Oxinium DH Femoral Heads Common Name: Femoral Head

Device Classification Name and Reference: 21 CFR 888.3350 (Hip joint metal/polymer semiconstrained cemented prosthesis - Class II); and 21 CFR 888.3358 (Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis - Class II) Device Product Code: JDI, LPH

### Device Description

The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

| Description - - - | 510(k) | Clearance<br>Date |
|--------------------------------------------------------|---------|-------------------|
| Echelon (Revision) Hip Stems - Porous and Non-porous | K963486 | 11/27/96 |
| Echelon Primary Hip Stems | K983834 | 2/24/99 |
| Echelon Hip Stems - HA Coated | KO23302 | 10/25/02 |
| Synergy (Tapered) Hip Stems - Porous and Non-porous | K963509 | 1/27/97 |
| Synergy (Tapered) Hip Stems - HA Press-fit | K970337 | 2/28/97 |
| Synergy Cemented Hip Stems | K990369 | 3/12/99 |
| Synergy Porous Size 8 Hip Stem | K991485 | 7/12/99 |
| Synergy HA Coated Porous Hip Stems | K002996 | 12/11/00 |
| Spectron Hip Stems | K970351 | 2/28/97 |
| Smith & Nephew Modular Hip (Emperion) | K042127 | 11/19/04 |
| Smith & Nephew Modular Hip (Emperion) - Line Additions | K052426 | 12/07/05 |
| Platform Hip Stem | K052275 | 12/07/05 |
| Anthology Hip Stems | K052792 | 10/07/05 |
| Smith & Nephew Patient Matched Hip Stem (PMHS) | K053246 | 7/12/06 |
| Smith & Nephew MIS Hip Stem | K072417 | 1/10/08 |
| Smith & Nephew MIS Hip Stem with StikTite | K080625 | 5/8/08 |
| SL-PLUS Standard and Lateral Hip Stems | K072852 | 6/9/08 |

Table 1: Previously cleared Smith & Nephew hip stems with a 12/14 taper

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K081566

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| Description | 510(k) | Clearance<br>Date |
|-------------------------------------------------------------------------------------------------|---------|-------------------|
| Reflection Acetabular Cup System (formerly the Modular Acetabular<br>Cup System) (cemented use) | K920430 | 7/21/92 |
| Reflection Acetabular Components (uncemented use) | K932755 | 5/6/94 |
| Reflection Dual Dimension Shell (Interfit Shells) | K960094 | 3/27/96 |
| Hydroxyapatite Reflection Acetabular Shells (Interfit HA coated shell) | K990666 | 8/6/99 |
| Reflection Cross-linked UHMWPE Acetabular Liners: 5 Mrad<br>Irradiation Dosage | K991026 | 10/28/99 |
| Reflection Cross-linked UHMWPE Acetabular Liners: 10 Mrad<br>Irradiation Dosage | K002747 | 12/15/00 |
| Smith & Nephew Hip System - Reflection 36 mm XLPE Liners | K022902 | 10/2/02 |
| Reflection 3 Acetabular System | K061253 | 5/31/06 |
| Reflection 3-Hole Shell with Asymmetric Porous Coating | K060630 | 6/14/06 |
| Reflection 3 Acetabular System | K070756 | 6/6/07 |

#### Table 2: Previously cleared Smith & Nephew acetabular liners and shells

### Mechanical Testing

A review of the mechanical testing results indicated that the Smith & Nephew Oxinium DH femoral heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Intended Use

Total 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, 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. Smith & Nephew Oxinium DH femoral heads are for single use only.

# Substantial Equivalence Information

The Smith & Nephew Oxinium DH femoral heads are similar in overall design, indications, and materials to the Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is simple and recognizable, representing the department's role in health and human services.

SEP 2-2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. Jason Sells Project Manager, Regulatory Affairs 1450 East Brooks Road Memphis, Tennessee 38116

Re: K081566 Trade Name: Oxinium DH Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI Dated: July 21, 2008 Received: July 22, 2008

Dear Mr. Sells:

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. Jason Sells

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 Biometrics' (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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Mulhausen

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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K081566

# Indications for Use

510(k) Number (if known):

Device Name: Oxinium DH Femoral Heads

Indications for Use:

Total 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, 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. Smith & Nephew Oxinium DH femoral heads are for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH. C ice of Device Evaluation (ODE)

Barbare Budup
Division Sign Off

Division of General, Restorative, and Neurological Devices

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510(k) Number K081566

Indications.doc