MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM

K142442 · Zimmer, Inc. · HWC · Oct 3, 2014 · Orthopedic

Device Facts

• Record ID: K142442
• Device Name: MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magna-FX Cannulated Bone Screws are indicated for fractures of: The intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required. The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw. The Mini Magna-FX Cannulated Bone Screws are indicated for: Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis. It can also be used in the reduction of small bone fragments and reduction and fixation with cerclage wire, and the fixation of bone prominences.

Device Story

Magna-FX Cannulated Screw Fixation System consists of self-reaming, self-tapping cannulated bone screws and washers. Used by orthopedic surgeons in clinical settings to provide rigid fixation for various bone fractures. Device facilitates accurate screw placement, often guided by image intensification fluoroscopy. System provides mechanical stabilization of bone fragments, promoting healing and structural integrity. No software or electronic components involved.

Clinical Evidence

No clinical data. Bench testing only: shelf life (10 years via accelerated aging), biocompatibility (ISO 10993-1), and mechanical performance (torsional properties and axial pull-out strength per ASTM F543).

Technological Characteristics

Cannulated bone screws and washers; self-reaming and self-tapping design. Mechanical fixation. Testing performed per ASTM F543 for torsional properties and axial pull-out strength. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients with fractures of the hip, femoral/tibial condyles, ankle, acetabulum, pelvis, medial malleolus, distal tibia/radius, calcaneus, talus, patella, or slipped capital femoral epiphysis; also for reduction of small bone fragments and fixation of bone prominences.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Cannulated Screws and Washers (Smith & Nephew, Inc., K111994)
• Synthes 6.5 mm Cannulated Screw (Synthes, K021932)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 3, 2014

Zimmer, Incorporated Mr. Stephen H. McKelvey, MA, RAC Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K142442

Trade/Device Name: Magna-FX® Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. NDG Dated: August 29, 2014 Received: September 2, 2014

Dear Mr. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Mr. Stephen H. McKelvey, MA, RAC

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald###ean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142442

Device Name

Magna-FX Cannulated Screw Fixation System

Indications for Use (Describe)

The Magna-FX Cannulated Bone Screws are indicated for fractures of:

· The intracapsular hip, femoral condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required.

· The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.

The Mini Magna-FX Cannulated Bone Screws are indicated for:

· Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis.

· It can also be used in the reduction of small bone fragments and fixation with cerclage wire, and the fixation of bone prominences.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary |
|----------------|
|----------------|

| Sponsor: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey, MA, RAC Senior Project Manager, Regulatory Affairs Telephone: [phone] Fax: [phone] |
| Date: | September 22, 2014 |
| Trade Name: | Magna-FX® Cannulated Screw Fixation System |
| Common Name: | Screw, Fixation, Bone Washer, Bolt, Nut, Non-Spinal, Metallic |
| Classification Names and References: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040, HWC) Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030, NDG) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Cannulated Screws and Washers, manufactured by Smith & Nephew, Inc., K111994, cleared October 11, 2011. Synthes 6.5 mm Cannulated Screw, manufactured by Synthes, K021932, cleared September 6, 2002. |
| Purpose and Device Description: | The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self- reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures. |

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| Intended Use: | The Magna-FX Cannulated Bone Screws are indicated for<br>fractures of: The intracapsular hip, femoral condyles, tibial<br>condyles, ankle, acetabulum, pelvis, and other areas where<br>accurate screw placement is required. The screw can also<br>be applied to slipped capital femoral epiphysis if image<br>intensification fluoroscopy is used to ascertain the proper<br>position of the screw. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Mini Magna-FX Cannulated Bone Screws are<br>indicated for: Fractures of the medial malleolus, distal<br>tibia, distal radius, calcaneus, talus, patella, and pelvis. It<br>can also be used in the reduction of small bone fragments<br>and reduction and fixation with cerclage wire, and the<br>fixation of bone prominences. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | • Shelf Life - Accelerated aging testing conducted<br>shows that the sterile devices included in this<br>submission have a shelf life of 10 years. |
| | • Biocompatibility – Biocompatibility testing of the<br>subject devices was conducted per ISO 10993-1 and<br>Good Laboratory Practices (21 CFR 58). All testing<br>passed. |
| | • Performance Testing – Testing performed included<br>evaluation of screw torsional properties and axial pull<br>out strength per ASTM F543. The results of non-<br>clinical performance testing demonstrate that the<br>devices are safe and effective and substantially<br>equivalent to the predicate devices. |
| | Conclusions: The non-clinical performance data presented<br>in this submission show that the devices are substantially |

substantial equivalence.

equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show