DEPUY SPA POROUS COATED PROXIMAL SLEEVE

K071059 · DePuy Orthopaedics, Inc. · KWZ · Nov 9, 2007 · Orthopedic

Device Facts

• Record ID: K071059
• Device Name: DEPUY SPA POROUS COATED PROXIMAL SLEEVE
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hp System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheatuatoid arthritis, ostecarthritis, post-traumatic arthritis, collages disorders, avascular necessis, and nominion of femoral fractures. Use of the prosthesis is also indicated for revision of premous hip arthroplasty and for patients with congenital hip dysplasia. protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion. The SPA Porous Coated Proximal Sleeves are intended for cementless use.

Device Story

DePuy SPA Porous Coated Proximal Sleeve is a component of the S-ROM Total Hip Replacement System. Device is a porous-coated titanium femoral component featuring an elliptical shape matching bone contour and a stepped exterior to maximize compressive stresses. Intended for cementless use, fixation is achieved via biologic tissue in-growth into the porous coating. Used by orthopedic surgeons in clinical settings during total hip arthroplasty or revision procedures to restore hip joint function and alleviate pain caused by structural damage or disease.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and manufacturing similarities to predicate devices.

Technological Characteristics

Titanium femoral component with porous coating. Elliptical shape with stepped exterior. Designed for cementless fixation via biologic tissue in-growth.

Indications for Use

Indicated for patients requiring total hip replacement due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fracture nonunion, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion; also indicated for revision of previous hip arthroplasty.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• S-ROM™ 135 Porous Coated Femotal Stem Collar (K860207)
• Coated ZT=14 Prosimal Sleeve (K934412)

Submission Summary (Full Text)

{0}------------------------------------------------

# K071059

# 510(k) SUMMARY

| NAME OF FIRM: | DePuy Orthopaedics Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Kathy Harris<br>Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] |
| DATE PREPARED: | October 20, 2007 |
| TRADE NAME: | DePuy SPA™ Porous Coated Proximal Sleeves |
| COMMON NAME: | Femoral Proximal Sleeve |
| CLASSIFICATIONS: | 21 CFR 888.3330: Hip joint metal/metal semi-constrained,<br>with an uncemented acetabular component, prosthesis, Class III |
| | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis,<br>Class II |
| | 21 CFR 888.3358: Hip joint metal/polymer semi-constrained<br>porous coated uncemented prosthesis, Class II |
| | 21 CFR 888.3310: Hip joint metal/polymer constrained<br>cemented or uncemented prosthesis, Class II |
| DEVICE PRODUCT CODES: | KWA, LZO, MEH, LPH, KWZ. |
| SUBSTANTIALLY | |

EQUIVALENT DEVICES: S-ROM™ 135 Porous Coated Femotal Stem Collar, K860207 cleared August 6, 1986

Coated ZT=14 Prosimal Sleeve, K934412 cleared June 3, 1994

## DEVICE DESCRIPTION:

a marka mana mana mana mana mana mana mana mana mana mara mara mar

The SPA Poeous Coated Peoximal Sleeve is a composent of the S-ROM Total Hip Replacement System. It is a porous coated Titanium femoral component with an elliptical shape that matches the contour of the bone and a stepped exterior to maximize compressive stresses. Fixation of the proximal sleeve to the femur is achieved by biologic fixation via tissue in-growth into the porous onsung.

{1}------------------------------------------------

#### INDICATIONS AND INTENDED USE:

The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hp System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheatuatoid arthritis, ostecarthritis, post-traumatic arthritis, collages disorders, avascular necessis, and nominion of femoral fractures. Use of the prosthesis is also indicated for revision of premous hip arthroplasty and for patients with congenital hip dysplasia. protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

and the contract and consistence of the country and the country and the con-

and and the commend of the

#### SUBSTANTIAL EQUIVALENCE:

The SPA Porous Coated Proximal Sleeve is identical in design, materials and manufacturing method to the S-ROM 135 Porcous Coated Femoral Stem Collar, cleared in K860207 for cemented use only. The porous coating of the SPA Porcous Coated Sleeve is identical to the porcus coating used on the Coated ZT Proximal Sleeve, cleared in K934412 for cemendess use. Based on these samilatines, DePuy believes that the SPA Porous Coated Proximal Sleeve is substantially equivalent to the referenced predicate devices.

# 0000026

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing segments, oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

DuPuy Orthopaedics, Inc. % Ms. Kathy Harris Director, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988

Re: K071059

Trade/Device Name: DePuy SPA™ Porous Coated Proximal Sleeves Regulation Number: 21 CFR 888.3330 Regulation Name: Single/multiple component metallic bone Fixation appliances and accessories Regulatory Class: Class III Product Code: LPH, MEH, LZO, and KWZ Dated: October 23, 2007 Received: October 24, 2007

Dear Ms. Harris:

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. Iisting 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 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.

{3}------------------------------------------------

Page 2 - Ms. Kathy Harris

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehlm

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number (if known): K071059

Device Name: DePuy SPA Porous Coated Proximal Sleeves

Indications for Use:

The SPA Porcus Coated Proximal Sleeve components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonumion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion.

The SPA Porous Coated Proximal Sleeves are intended for cementless use.

Prescription Use ানুষ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart Of

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buell

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

Page 1 of 1

**510(k) Number** K071059
00000025