ZETA MULTIZONE SCN LOCKING NAIL

K982873 · Howmedica Corp. · HSB · Oct 21, 1998 · Orthopedic

Device Facts

• Record ID: K982873
• Device Name: ZETA MULTIZONE SCN LOCKING NAIL
• Applicant: Howmedica Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

Device Story

Intramedullary fixation rod system for distal femoral fractures; components include supracondylar nails, cross-locking screws, condyle screws, condyle nut, and set screw. Device provides temporary stabilization of fractures, malunions, nonunions, and osteotomies; condyle screw/nut assembly facilitates fixation in osteoporotic bone and compression of supracondylar fragments. Inserted via open or closed retrograde technique by orthopedic surgeons in clinical/OR settings. Titanium alloy construction ensures biocompatibility and structural support for bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Medical grade titanium alloy; intramedullary rod system; retrograde insertion; mechanical fixation via screws and nuts; no software or electronic components.

Indications for Use

Indicated for patients requiring temporary stabilization of distal femur fractures, malunions, nonunions, or supracondylar region fractures. Also indicated for reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures, and fusions.

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

• Howmedica SCN Nail
• Depuy Ace AIM® Titanium Supracondylar Nail

Submission Summary (Full Text)

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OCT 21 1998

## 510(k) Summary

Zeta MultiZone SCN Locking Nail Proprietary Name: Common Name: IM Rod Intramedullary Fixation Rod Classification Name & 21 CFR 888.3020 Reference: Proposed Regulatory Class: II Device Product Code: 87HSB

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: [phone] Fax: [phone]

The Zeta MultiZone SCN Locking Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade titanium alloy.

The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Howmedica's SCN Nail and Depuy Ace's AIM® Titanium Supracondylar Nail.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Ms. Vivian Kelly Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard -Rutherford, NJ 07070

Re: K982873 Zeta MultiZone SCN Locking Nail Trade Name: Requlatory Class: II Product Code: HSB August 13, 1998 Dated: Received: August 14, 1998

Dear Ms. Kelly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Vivian Kelly

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 origo or compitied, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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

Enclosure

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Indications for Use

510(k) Number (if known): K982873

Device Name: Zeta MultiZone SCN Locking Nail

Indications for Use:

The Zeta MultiZone SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

A

(Division Sign-Off) Division of General Restorative Devices <10/V) Number