ACCOLADE HFX FEMORAL STEM

K051741 · Stryker Orthopaedics · LZO · Sep 26, 2005 · Orthopedic

Device Facts

• Record ID: K051741
• Device Name: ACCOLADE HFX FEMORAL STEM
• Applicant: Stryker Orthopaedics
• Product Code: LZO · Orthopedic
• Decision Date: Sep 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accolade® HFx hip stem is a single-use, sterile device intended for cementless fixation within the prepared femoral canal.

Device Story

Accolade® HFx femoral stem is a tapered, collarless, flat-bodied cobalt chrome prosthesis designed for cementless fixation in the femoral canal. Proximal body features a textured surface to increase surface area for press-fit. Device is intended for use in total hip joint replacement procedures performed by orthopedic surgeons in a clinical/hospital setting. It serves as a replacement for the femoral component of the hip joint, aiming to restore joint function and alleviate pain associated with degenerative disease, arthritis, or fractures. The device is implanted during surgery; clinical decision-making relies on surgeon assessment of patient anatomy and pathology.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarities to the predicate device.

Technological Characteristics

Material: Cobalt chrome. Design: Tapered, collarless, flat-bodied femoral stem. Fixation: Cementless (press-fit). Sizes: 1 through 8. Surface: Textured proximal body. Sterilization: Not specified.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision procedures, and nonunion or fractures of the proximal femur with head involvement unmanageable by other techniques.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Accolade® TMZF® femoral stem (K994366)

Submission Summary (Full Text)

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SEP 26 2005

325 Corporate Drive Mahwah, NJ USA 07430

Howmedica

OSTEONICS

STITUKE

K 051741

# 510(k) Summary of Safety and Effectiveness for the Accolade® HFx Femoral Stem

| Proprietary Name: | Accolade® HFx Femoral Stem |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Hip Joint Replacement Prosthesis |
| Classification Name and Reference | Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis,<br>21 CFR §888.3360 |
| | Hip joint, metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prostheses,<br>21 CFR §888.3353 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 KWL - prosthesis, hip, hemi-, femoral, metal |
| | 87 LWJ - prosthesis, hip, semi-constrained,<br>metal/polymer, uncemented |
| | 87 LZO - prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented |
| For Information contact: | Tiffani Rogers<br>Regulatory Affairs Specialist<br>Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, New Jersey 07430<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Summary Prepared: | June 27, 2005 |

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Image /page/1/Picture/0 description: The image shows the logos of Stryker, Howmedica, and Osteonics. Stryker is in a bold, sans-serif font, while Howmedica and Osteonics are stacked on top of each other in a similar font. The logos are all in black and white and are arranged horizontally.

325 Corporate Drive Mahwah, NJ USA 07430

### Device Description

The Accolade® HFx femoral stem is a tapered cobalt chrome stem. The Accolade® HFx femoral stem is collarless and flat bodied, and will be available in sizes 1 through 8. The proximal body is textured Is conaress and hit boured, and firm of a increase the surface area of the stem to accommodate a press-fit fixation.

#### Intended Use:

The Accolade® HFx hip stem is a single-use, sterile device intended for cementless fixation within the prepared femoral canal.

## Indications

- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and, ●
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.

#### Substantial Equivalence

The determination of the substantial equivalence of the Accolade® hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E.

K051741
p²/₂

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards, representing health, services, and people. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.

Public Health Service

SEP 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tiffani D. Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051741 Trade/Device Name: Accolade® HFx Femoral Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, LWJ, KWL Dated: June 27, 2005 Reccived: June 28, 2005

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed 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 for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the corney 2011 de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diere, mains of the Act include requirements for annual registration, listing of general controls proficition 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 if your device is exassinon von ontrols. Existing major regulations affecting your device can may oe subject to oach adderal 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 r lease be deviloed that the mination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set El K Fat 801); accems (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- Ms. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manieting of substantial equivalence of your device to a legally premarket notification: "The PDF intemsessification 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 If you desire specific acries ion 10. Jour 2012 - 120. Also, please note the regulation entitled, Comaci the Office of Compuners and (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general involmation on your respended its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millikan

Mark N. Melkerson Acting 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): _ KOS1741

Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Indications

- Noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR (Per 21 CFR 801.109)

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

(Division Sign-Off) estorative, Division of General, F Division of Ogical Devices

510(k) Number_