SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS

K041170 · Howmedica Osteonics Corp. · LZO · Nov 9, 2004 · Orthopedic

Device Facts

• Record ID: K041170
• Device Name: SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty. The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Story

Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are orthopedic implants for cementless fixation in femoral canals during hip arthroplasty. This modification introduces a streamlined neck geometry and a modified C-Taper trunnion length to the existing stem design. The device is implanted by a surgeon in an operating room setting. It functions as a structural component of a total hip replacement system, providing stability and articulation support. The modification aims to maintain clinical performance while optimizing neck geometry. Benefits include restoration of hip function and treatment of degenerative or traumatic joint conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cementless hip stem prosthesis. Features streamlined neck geometry and modified C-Taper trunnion. Materials, manufacturing, and sterilization methods are identical to previously cleared predicate devices.

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, or proximal femoral fractures (non-union, femoral neck, trochanteric) with head involvement.

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

• Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems (K941366)
• Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems (K951517)
• Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems (982032)
• Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems (K990203)
• Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems (K020615)

Submission Summary (Full Text)

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K041170

## Traditional 510(k) Summary of Safety and Effectiveness for the MODIFICATION TO SECUR-FIT™ HA AND SECUR-FIT™ PLUS HIP STEMS

| Proprietary Name: | Secur-Fit™ HA and Secur-Fit™ Plus Hip |
|-----------------------------------|-------------------------------------------------------------------------------------------------------|
| Stems | |
| Common Name: | Artificial Hip Components |
| Classification Name and Reference | Hip joint, metal/ceramic/polymer semi-<br>constrained cemented or nonporous<br>uncemented prostheses, |
| | 21 CFR §888.3353 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MEH, 87 LZO |
| For Information contact: | Karen Ariemma |
| | Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 325 Corporate Drive |
| | Mahwah, New Jersey 07430 |
| | Phone: [phone] |
| | Fax: [phone]<br>E-Mail: [e-mail] |

Date Summary Prepared:

November 4, 2004

### Device Description

The currently marketed Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems were revised to incorporate a streamlined neck geometry and modify the C-Taper trunnion length.

### Intended Use:

The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

#### Indications for Use

The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- Rheumatoid arthritis; ●
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and .
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal . femur with head involvement that are unmanageable using other techniques.

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#### Substantial Equivalence:

The features of the modified stems are substantially equivalent to the corresponding features of the predicate Osteonics Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems determined substantially equivalent via 510(k)s K941366, K951517, 982032, K990203, and K020615. The modified stems are similar to the predicate stems in every aspect with the exception of the streamlined neck geometry and the modified C-Taper trunnion The testing used to evaluate the subject stems demonstrates substantial length. equivalence of the modified device to the predicate device in regards to neck strength. In addition, the intended use, material, manufacturing methods, packaging, package insert, and sterilization of the modified and unmodified stems are identical.

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three figures or lines above a wavy base, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. New Jersey 07430

Re: K041170

Trade/Device Name: Modification to Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO, MEH Dated: October 15, 2004 Received: October 21, 2004

Dear Ms. Ariemma:

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 - Karen Ariemma

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,

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): __K041170

Device Name: Modification to SECUR-FIT™ HA and SECUR-FIT™ PLUS Hip Stems

Indications For Use:

The Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems are single-use devices and are intended for cementless fixation within the prepared femoral canals of patients requiring hip arthroplasty.

The indications for use of the Osteonics® Secur-Fit™ HA and Secur-Fit™ Plus Hip Stems as a Total Hip Replacement include:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
- . Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark
(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number K041170