SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS

K020615 · Howmedica Osteonics Corp. · MEH · May 13, 2002 · Orthopedic

Device Facts

• Record ID: K020615
• Device Name: SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: May 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).

Device Story

Super Secur-Fit™ HA and Super Secur-Fit™ Plus HA Hip Stems are orthopedic implants for total hip arthroplasty. These cementless, single-use metal stems replace the femoral component of the hip joint. Modifications from predicate devices include transition from C-Taper to V40™ Taper, trimmed neck diameter, and addition of a modular collar slot. The device is implanted by orthopedic surgeons in a hospital/OR setting. The stem is mechanically assembled to a mating Howmedica V40™ Femoral Head (excluding +16mm size) during surgery. The device provides structural support and joint articulation, aiming to restore hip function and mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Neck fatigue testing was conducted in accordance with ISO 7206-6 to validate the structural performance of the modified neck design.

Technological Characteristics

Cementless hip prosthesis; V40™ Taper interface; modular collar slot; trimmed neck geometry. Materials: Metal (implied titanium/alloy consistent with predicate). Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring total hip replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity, failed previous treatments/devices, or femoral neck/trochanteric fractures unmanageable by other techniques.

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

• Secur-Fit™ HA Hip Stems (6051A series) (K010615)
• Secur-Fit™ HA Hip Stems (6052A series) (K010615)
• Secur-Fit™ Plus HA Hip Stems (6054A series) (K010615)

Submission Summary (Full Text)

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

MAY 1 3 2002

K010615

Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems

Special 510(k) Summary:

| Proprietary Name: | Super Secur-Fit™ HA Hip Stems and Super Secur-<br>Fit™ Plus HA Hip Stems |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name : | Artificial Hip Components |
| Classification Name and Reference: | Hip joint, metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis, 21<br>CFR §888.3353 |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | 87 MEH |
| For Information contact: | Jennifer Daudelin<br>Howmedica Osteonics Corp.<br>59 Route 17<br>Allendale, New Jersey 07401<br>Phone: [phone]<br>Fax: [phone] |

## Description/Technological Comparison

| Predicate Device Name/Catalog<br># Series | Subject Modifications | Resulting Subject Device<br>Name/Catalog # Series |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------|
| Secur-Fit™ HA Hip Stems (6051A<br>series), 132° neck angle | • Change C-Taper to V40™ Taper<br>• Trim neck diameter<br>• Add slot for modular collar | Super Secur-Fit™ HA Hip<br>Stems (J6051 series) |
| Secur-Fit™ HA Hip Stems (6052A<br>series), 127° neck angle | • Change C-Taper to V40™ Taper<br>• Trim neck diameter | Super Secur-Fit™ HA Hip<br>Stems (J6052 series) |
| Secur-Fit™ Plus HA Hip Stems<br>(6054A series), 127° neck angle | • Change C-Taper to V40™ Taper<br>• Trim neck diameter | Super Secur-Fit™ Plus HA<br>Hip Stems (J6054 series) |

## Intended Use

The intended use of the modified hip stems remains essentially unchanged from that of the predicate hip stems. Like the predicate devices, the subject devices are single-use components intended for cementless fixation within the prepared canals of patients requiring hip arthroplasty. Unlike the predicate devices, however, the subject devices feature a V40™ Taper, and are

Special 510(k)

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

Pge 2 of 2

#### Modification to Secur-Fit™ HA Hip Stems and Secur-Fit™ Plus HA Hip Stems

Special 510(k)

therefore intended only for assembly to mating, commercially available Howmedica V40™ Femoral Heads. Note, also, that the subject hip stems are not recommended for use with size +16mm V40TM Femoral Heads.

## Testing Summary

Neck fatigue testing was performed in accordance with ISO 7206-6.

Page 4

{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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 3 2002

Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Re: K020615

Trade/Device Name: Modification to Secur-Fit" HA and Secur-Fit" Plus HA Hip Stems Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: Class II Product Code: MEH Dated: April 22, 2002 Received: April 23, 2002

Dear Ms. Daudelin:

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 forth in the quality systems (OS) 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. Jennifer A. Daudelin

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 proficated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Mark N Millan

Witten. Ph.D., M.D. Celia M. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

620615 510(k) Number (if known): _

Device Name: Modification to Secur-Fit™ HA Hip Stems and Secur-FirM Plus HA Hip Stems (Super Secur-Fit™ HA Hip Stems and Super Secur-Fit™ Plus HA Hip Stems)

The subject hip stems are single-use devices intended for use in total hip replacement. They are designed for cementless fixation. They are intended for mechanical assembly to mating Howmedica V40™ Femoral Heads (excluding size +16mm (XX Long) V40 Femoral Heads).

#### Indications:

The indications for use of total hip replacement prostheses include:

- e indications for ass of total inp repartises including osteoarthritis and avascular necrosis, ●
- Rheumatoid arthritis, �
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, and .
- Revision procountes where outler areasing neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use */No* (Per 21 CFR 801.109)
(Optional Format 1-2-96)

for Mark n Milhersen

Sion Sign-( Division of General. Restorative and Neurological revices

510(k) Number K020615