SHORT CITATION FEMORAL STEM

K053528 · Stryker Orthopaedics · MEH · Jan 13, 2006 · Orthopedic

Device Facts

• Record ID: K053528
• Device Name: SHORT CITATION FEMORAL STEM
• Applicant: Stryker Orthopaedics
• Product Code: MEH · Orthopedic
• Decision Date: Jan 13, 2006
• 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 primary 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

Short Citation® Femoral Stem is an anatomic hip prosthesis for total hip replacement; used in primary reconstruction of proximal femur or revision arthroplasty. Device features 132° neck angle; manufactured from TMZF® titanium alloy; proximal body includes circumferential CP titanium plasma spray and hydroxyapatite coating. Available in 10 sizes with left/right orientation. Implanted by orthopedic surgeons in clinical/hospital settings. Device mates with Howmedica Osteonics acetabular components and V40™ femoral heads via TMZF® 5° 40' BG trunnion. Provides structural reconstruction of femoral head/neck; restores joint function; benefits patients by addressing degenerative disease, fractures, or failed prior implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: TMZF® titanium alloy. Surface: Circumferential CP titanium plasma spray and hydroxyapatite coating on proximal body. Design: Anatomic stem, 132° neck angle, anteverted neck and proximal stem. Connectivity: None (mechanical implant). Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring cementless primary hip surgery for 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

• Citation® TMZF® femoral stem (K993768)

Submission Summary (Full Text)

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/**Stryker**
**Howmedica**

JAN ] 3 2006

K053528

510(k) Summary of Safety and Effectiveness for the

## Short Citation® Femoral Stem

325 Corporate Drive Mahwah, NJ USA 07430

| Proprietary Name: | Short Citation® Femoral Stem |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Hip Joint Replacement Prosthesis |
| Classification Name and Reference | Hip joint, metal/ceramic/polymer semi-<br>constrained cemented or nonporous<br>uncemented prostheses,<br>21 CFR §888.3353 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MEH - prosthesis, hip, semi-constrained,<br>uncemented, metal/polymer, non-porous,<br>calcium-phosphate, |
| | 87 LZO - prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-<br>porous, 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: | December 16, 2005 |

# Device Description

The Short Citation® hip is an anatomic stem with a 132° neck angle. The device is manufactured from TMZF® Titanium metal and features a circumferential coating of CP titanium plasma spray and hydroxyapatite coating on the proximal body. Both the neck and the proximal stem are anteverted for proximal fill. The Short Citation® hip is available in 10 sizes with right and left orientation.

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### 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 primary 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.

#### Indications:

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, 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. .

#### Substantial Equivalence:

The determination of the substantial equivalence of the Short Citation® hip stem is based on its similarities in intended use, design and sterilization to the Citation® TMZF® femoral stem (K993768, cleared January 21, 2000). Predicate device information is located in Appendix E.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

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

Re: K053528

Trade/Device Name: Short Citation® 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: MEH, LZO Dated: December 16, 2005 Received: December 19, 2005

Dear Ms. Rogers:

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

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## Page 2 – Ms. Rogers

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. This letter will allow you to begin marketing your device as described in your Section 510(k) rms let 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 N. Mellekerson

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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# 1053528

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Indications

- Cementless primary hip surgery in cases of non-inflammatory degenerative joint . disease including osteoarthritis, 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 Use

OR

Over-the-Counter

(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)

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

K0535 28 510(k) Number