DUPUY S-ROM STD HIP STEM PROSTHESIS

K061221 · DePuy Orthopaedics, Inc. · KWA · Aug 28, 2006 · Orthopedic

Device Facts

• Record ID: K061221
• Device Name: DUPUY S-ROM STD HIP STEM PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Aug 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the component.

Device Story

The DePuy S-ROM® STD Hip Stem Prosthesis is a titanium femoral component for total hip arthroplasty. This line extension adds a +12L option to existing standard stem sizes, providing increased lateralization (+12 mm) to assist in restoring anatomical biomechanics by adjusting offset without affecting leg length. The device is intended for use by orthopedic surgeons in a clinical/surgical setting. By replacing damaged hip joint articulation, the prosthesis aims to increase patient mobility and reduce pain. It is designed for uncemented fixation in patients with sufficient sound bone to support the component.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium femoral hip stem prosthesis; uncemented design. Line extension adds +12L lateralization option to existing 19x24x175mm and 21x26x175mm stem sizes with 36mm neck. Designed for semi-constrained hip joint replacement.

Indications for Use

Indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for patients suffering severe pain and disability due to structural damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, nonunion of femoral fractures, revision of previous hip arthroplasty, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• DePuy S-ROM® Femoral Hip Stem (K961939)
• DePuy S-ROM® STD Hip Stem Prostheses (K851422)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>EST REG No.: 1818910 |
|---------------|--------------------------------------------------------------------------------------------------------|
|---------------|--------------------------------------------------------------------------------------------------------|

| | AUG 2 8 2006 |
|--|--------------|
|--|--------------|

| 510(K) CONTACT: | Anne Schuler<br>Sr. Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone] |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| DATED PREPARED: | June 22, 2006 |
| TRADE NAME: | DePuy S-ROM® STD Hip Stem Prosthesis |
| COMMON NAME: | Cementless Hip Stem Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-<br>constrained porous coated uncemented prosthesis,<br>Class II |
| | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-<br>constrained cemented or non-porous uncemented prosthesis,<br>Class II |
| | 21 CFR 888.3330 Hip joint metal/metal semi-constrained,<br>with an uncemented acetabular component prosthesis,<br>Class III |
| DEVICE PRODUCT CODES: | LPH, LZO, KWA |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | DePuy S-ROM® Femoral Hip Stem (K961939, cleared<br>August 13, 1996) |
| | DePuy S-ROM® STD Hip Stem Prostheses (K851422,<br>cleared July 9, 1985 with additional modifications |

#### DEVICE DESCRIPTION:

The subject DePuy S-ROM® Hip Stem is a line extension to the 36mm S-ROM® titanium stems previously cleared in K961939 and K851422. The line extension adds a +12L option to the previously cleared standard stem sizes 19 x 24 x 175 w/36mm neck and 21 x 26 x 175 w/36mm neck. These two new stems will provide greater lateralization (+12 mm) to the standard stem of comparable diameters. The increased lateralization assists in restoring anatomical biomechanics through adjusting off-set without effecting leg length.

cleared through internal documentation)

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#### INTENDED USE AND INDICATIONS:

#### INTENDED USE:

The DePuy S-ROM® Hip Stem Prosthesis is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the component.

#### INDICATIONS FOR USE:

The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

#### SUBSTANTIAL EQUIVALENCE:

The fundamental scientific technologies of the subject DePuy S-ROM® Hip Prosthesis have not changed from the FDA-cleared DePuy S-ROM® Hip Stem (K961939). They have the same intended use, indications, sterilization method, packaging, materials, method of manufacture and design. DePuy believes that the subject DePuy S-ROM® Hip Prosthesis is substantially equivalent to the FDAcleared DePuy S-ROM® Hip Stem (K961939).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 8 2006

Ms. Anne Schuler Senior Regulatory Affairs Specialist DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K061221 Re.

Trade/Device Name: S-ROM STD Hip Stem Prosthesis Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: August 16, 2006 Received: August 17, 2006

Dear Ms. Schuler:

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

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Page 2 - Ms. Anne Schuler

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. 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/industry/support/index.html.

Sincerely vours.

Oaibaie Buellm

Mark N. Melkerson, M.S 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

15061221 510(k) Number (if known): Device Name: DePuy S-ROM® Hip Stem Prosthesis

Indications for Use:

The DePuy S-ROM® Hip Stem Prosthesis is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicted for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

| 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, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| | Kaubare BuchelD |
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| | for MKM |

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| 510(k) Number | K061221 |
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