HIPSTAR FEMORAL STEM

K051223 · Stryker Orthopaedics · LZO · May 10, 2006 · Orthopedic

Device Facts

• Record ID: K051223
• Device Name: HIPSTAR FEMORAL STEM
• Applicant: Stryker Orthopaedics
• Product Code: LZO · Orthopedic
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

The Hipstar Femoral Stem is a straight, titanium alloy (TMZF) implant designed for cementless fixation in the femoral canal. It features a proximal lateral flare for rotational stability and a narrow distal stem. The body is iron grit blasted to enhance bone-to-implant interface, excluding the trunnion, neck, and distal tip. Used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty, the device replaces the femoral head and neck to restore joint function. It provides structural support and stability for patients suffering from degenerative joint disease, fractures, or failed previous implants. By facilitating bone ingrowth through its surface treatment, the stem aims to provide long-term fixation, reduce pain, and improve mobility for patients requiring hip reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: TMZF titanium alloy. Surface: Iron grit blasted body (excluding trunnion, neck, distal tip). Design: Straight stem with proximal lateral flare and narrow distal stem. Fixation: Cementless. Sterilization: Not specified.

Indications for Use

Indicated for total and hemi hip arthroplasty in patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments/devices, and nonunion, femoral neck, or trochanteric fractures of the proximal femur. When used with a constrained acetabular liner, indicated for primary and revision total hip arthroplasty in patients at high risk of dislocation due to history of dislocations, bone loss, joint/soft tissue laxity, neuromuscular disease, or intraoperative instability.

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

• Alloclassic™ Zweymueller™ SL/SLL femoral hip stem (K030373)

Submission Summary (Full Text)

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K05/223

**stryker**
Howmedica
OSTEONICS

1 10

## 510(k) Summary of Safety and Effectiveness for the HIPSTAR Femoral Stem

325 Corporate Drive Mahwah, NJ USA 07430

Proprietary Name:

Common Name:

Regulatory Class:

Device Product Code:

Classification Name and Reference

HIPSTAR Femoral Stem

Total Hip Joint Replacement Prosthesis

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

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR §888.3360

Hip joint metal/polymer constrained cemented or uncemented prosthesis 21 CFR §888.3310

Class II

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

87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented

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

87 KWL - prosthesis, hip, hemi-, femoral, metal

87 KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer

ЭЭДАЯ

02/120

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For Information contact:

Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Summary Prepared:

May 5, 2006

KOS 1223

### Device Description

The Hipstar® Femoral Stem is a straight hip stem manufactured from titanium alloy, TMZFTM. The Hipstar® hip features a proximal, lateral flare for rotational stability, with a narrow distal stem for implant stability. The body of the stem, with the exception of the trunnion, neck and distal tip, is iron grit blasted for increased bone to implant interface.

### Intended Use:

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

#### Indications

The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:

- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-. Apatite coated prostheses);
- . 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.

When mated with a constrained acctabular liner the Hipstar® Hip Stern is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

#### Substantial Equivalence:

The determination of the substantial equivalence of the HIPSTAR® hip stem is based on its similarities in intended use, design and sterilization to Zimmer's Alloclassic™ Zweymueller™ SL/SLL femoral hip stem (K030373, cleared March 06, 2003).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is composed of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

Stryker® Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432

Re: K051223

Trade/Device Name: Hipstar® Hip Stem Regulation Number: 21 CFR 878.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZO Dated: March 31, 2006 Received: April 3, 2006

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. Tiffani 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) 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Hubert Semeno

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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# K051223

510(k) Number (if known): ___

Device Name: Hipstar® Hip Stem___

#### Indications

The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:

- noninflammatory degenerative joint disease including osteoarthritis and avascular � necrosis:
- rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-. Apatite coated prostheses);
- 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 . treatment of nonamon, remot that are unmanageable using other techniques.

When mated with a constrained acetabular liner the Hipstar® Hip Stem is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Hipstar® Hip Stem is intended for cementless use only.

X Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

Huker Lemer to

(Division Division of General. Restorative. and Neurological Devices

**510(k) Number** K051223