ACCOLADE RPS HIP STEM

K052542 · Stryker Orthopaedics · LZO · Sep 27, 2005 · Orthopedic

Device Facts

• Record ID: K052542
• Device Name: ACCOLADE RPS HIP STEM
• Applicant: Stryker Orthopaedics
• Product Code: LZO · Orthopedic
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.

Device Story

Accolade® RPS Femoral Stem is a modification of the Accolade® TMZF® hip system; designed for total hip replacement. Device features TMZF® alloy construction with reduced surface area for Commercially Pure Titanium (CP-Ti) plasma spray and PureFix™ HA coatings. Used in OR by orthopedic surgeons for primary or revision hip arthroplasty. Device acts as a femoral component, mating with V40™ femoral heads and Howmedica Osteonics acetabular components. Provides structural reconstruction of proximal femur/femoral joint head and neck. Benefits patients by restoring joint function in cases of degenerative disease or fracture.

Clinical Evidence

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

Technological Characteristics

Materials: TMZF® alloy, Commercially Pure Titanium (CP-Ti) plasma spray, PureFix™ HA coating. Design: Femoral stem for total hip replacement, semi-constrained, uncemented. Connectivity: None (mechanical implant). Sterilization: Sterile, single-use.

Indications for Use

Indicated for cementless primary hip surgery in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity); treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement; and revision procedures where other treatments have failed.

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 2 7 2005

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325 Corporate Drive
Mahwah, NJ USA 07430

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

**Proprietary Name:**

Common Name:

Classification Name and Reference

Regulatory Class:

Device Product Code:

For Information contact:

Accolade® RPS Femoral Stem

Total Hip Joint Replacement Prosthesis

Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353

Class II

87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate,

87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Summary Prepared:

September 13, 2005

## Device Description

The existing Accolade® TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on

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I body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.

### ended Use:

The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is The subject imp stem is a = = =
intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This intended for primary
device is intended for use with any currently available Howmedica Osteonics acetabular device is miches.
component and V40™ femoral heads that can be mated with a TMZF® 5° 40' BG trunnion.

#### Indications:

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . Cententess primary inf varseular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .

#### Substantial Equivalence:

The determination of the substantial equivalence of the Accolade® RPS 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.

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SEP 27 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052542 Trade/Device Name: Accolade® RPS Hip 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 Code: LZO, MEH Dated: September 14, 2005 Received: September 15, 2005

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regions the Medical Device Amendments, or to commerce prior to May 20, 1976, in ecordance with the provisions of the Federal Food, Drug, devices mat have been reculise in assess as as a proval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to not request in the general controls provisions of the Act. The 1 ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 classified (see aberty) als. Existing major regulations affecting your device can may be subject to saterial 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 rease oe avrised has i termination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of uny I odelul states and we wents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF 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- Ms. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin mantening of substantial equivalence of your device to a legally premarket nothleanon. The PDA maing of cacommand of 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 advice for Jour do 110-76-0120. Also, please note the regulation entitled, p Colliact the Office of Complance at (1) + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misoranting by release to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,
Mark A. Millerson

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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| 510(k) Number (if known): | |
|---------------------------|------------------------|
| Device Name: | Accolade® RPS Hip Stem |

Indications for Use

Indications

- Cementless primary hip surgery in cases of non-inflammatory

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including ostcoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. .

Prescription Use X

OR Over-the-Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark D. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number