SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES

K043270 · Zimmer GmbH · HSB · Jan 31, 2005 · Orthopedic

Device Facts

• Record ID: K043270
• Device Name: SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
• Applicant: Zimmer GmbH
• Product Code: HSB · Orthopedic
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sirus intramedullary nail for femur with cap screw and corresponding locking screws: • All compound and simple femoral shaft fractures • Sub-trochanteric fractures • Pseudarthrosis and delayed union Sirus intramedullary nail for femur in combination with the Sirus cervical screws: • Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures Sirus intramedullary nail for tibia with cap screw and corresponding locking screws: • Simple, compound first- and second-degree tibial shaft fractures • Pseudarthrosis and delayed union

Device Story

Sirus Intramedullary Nail is a titanium alloy fixation device designed for insertion into the medullary canal of the femur or tibia. It provides structural support for fracture stabilization. The system includes the nail, cap screws, locking screws, and optional cervical screws for specific femoral fracture combinations. It is intended for use by orthopedic surgeons in clinical settings to treat fractures, pseudarthrosis, and delayed union. By stabilizing bone segments, the device facilitates healing and restores structural integrity to the affected limb.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical performance analysis.

Technological Characteristics

Manufactured from titanium alloy. Available in various lengths and diameters. Intramedullary fixation rod design. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients with femoral shaft fractures (compound/simple, sub-trochanteric), femoral shaft fractures combined with femoral neck or peritrochanteric fractures, tibial shaft fractures (simple, compound 1st/2nd degree), and cases of pseudarthrosis or delayed union.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Unreamed Tibial Nail (K932330)
• Lateral Entry Femoral Nail System (K040336)
• Osteo IC Retrograde/Antegrade Femoral Nail (K982601)
• T2 Femoral Nail System (K010801, K014220, K021744)

Submission Summary (Full Text)

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

093270

y

Image /page/0/Picture/1 description: The image shows the letters 'f' and 'z' in a handwritten style. The letters are connected, with the 'f' appearing first and the 'z' following it. The handwriting is simple and clear, making the letters easily recognizable.

Image /page/0/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter "Z" is black, while the circle is white with a black outline, and the word "zimmer" is also black.

# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura D. Williams, RAC<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | November 24, 2004 |
| Trade Name: | <i>Sirus</i> ® Intramedullary Nail |
| Classification Name<br>and Reference: | Intramedullary Fixation Rod<br>21 CFR § 888.3020 |
| Predicate Devices: | Unreamed Tibial Nail, manufactured by Synthes,<br>K932330, cleared 03/08/1996<br>Lateral Entry Femoral Nail System by Synthes,<br>K040336, cleared 04/12/2004<br>Osteo IC Retrograde/Antegrade Femoral Nail,<br>manufactured by Osteonics, K982601, cleared<br>09/14/1998<br>T2 Femoral Nail System, manufactured by<br>Howmedica Osteonics, K010801, K014220, and<br>K021744; cleared 04/06/2001, 01/25/2002, and<br>06/26/2002, respectively |
| Device Description: | The <i>Sirus</i> Intramedullary Nails are manufactured<br>from titanium alloy, and are available in a variety of<br>lengths and diameters. They are intended for<br>insertion into the medullary canal of the femur or<br>tibia for the fixation of fractures. |

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

Image /page/1/Picture/1 description: The image contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized "Z" inside. The logo and the word "zimmer" appear to be part of a company or brand identity.

p

જુજરી, ચણ

| Intended Use: | Sirus intramedullary nail for femur with cap<br>screw and corresponding locking screws: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • All compound and simple femoral shaft fractures |
| | • Sub-trochanteric fractures |
| | • Pseudarthrosis and delayed union |
| | Sirus intramedullary nail for femur in<br>combination with the Sirus cervical screws: |
| | • Shaft fractures in combination with femoral neck<br>fractures or peritrochanteric fractures |
| | Sirus intramedullary nail for tibia with cap<br>screw and corresponding locking screws: |
| | • Simple, compound first- and second-degree tibial<br>shaft fractures |
| | • Pseudarthrosis and delayed union |
| Comparison to Predicate Device: | The Sirus Intramedullary Nail has the same<br>intended use, has similar performance<br>characteristics, is manufactured from similar<br>materials using similar processes, and is similar in<br>design to the predicate devices. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | The results of non-clinical analysis demonstrate that<br>the device is safe and effective and substantially<br>equivalent to the predicate device(s). |

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and converge, resembling a human figure or a stylized representation of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Zimmer GMBH C/o Zimmer, Inc Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 465810

Re: K043270

Trade/Device Name: Sirus™ Intramedullary Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 24, 2004 Received: November 26, 2004

Dear Ms. Williams:

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.

Picase 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 fisting (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. Laura D. Williams, RAC

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 yours,

A. Mark A. Millkens

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

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

K64 3270 141

# Indications for Use

#### 510(k) Number (if known):

Device Name:

Sirus™ Intramedullary Nail

#### Indications for Use:

# Sirus intramedullary nail for femur with cap screw and corresponding locking screws

- · All compound and simple femoral shaft fractures
- · Sub-trochanteric fractures
- · Pseudarthrosis and delayed union

### Sirus intramedullary nail for femur in combination with the Sirus cervical screws

- · Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
# Sirus intramedullary nail for tibia with cap screw and corresponding locking screws

- · Simple, compound first- and second-degree tibial shaft fractures
- · Pseudarthrosis and delayed union

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)

(Division Sign-Off)
Division of General, Resative,
and Neurological Devices

K043370

\$10(k) Number

Page 1 of 1