ENSPLINT TM BONE SCREW

K080778 · Sonoma Orthopedic Products, Inc. · HWC · Jul 10, 2008 · Orthopedic

Device Facts

• Record ID: K080778
• Device Name: ENSPLINT TM BONE SCREW
• Applicant: Sonoma Orthopedic Products, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.

Device Story

Ensplint™ Bone Screws are metallic bone fixation fasteners; used for treating fractures of small and long bones. Device is a self-tapping cortical bone screw; diameters 1.5mm to 5.0mm; lengths 4mm to 90mm. Used by surgeons in clinical settings for internal bone fixation. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; self-tapping cortical screw; diameters 1.5mm-5.0mm; lengths 4mm-90mm; conforms to ASTM F543-2 standard specification for HA bone screws.

Indications for Use

Indicated for patients with fractures of small and long bones requiring fixation. Can be used in conjunction with the EnsplintRx Distal Radius System.

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

• Syntec-Taichung Non-Sterile Bone Plate and Screw Implants (K983495)

Submission Summary (Full Text)

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## 510(K) SUMMARY

JUL 1 0 2008

| Submitter's name: | Sonoma Orthopedic Products, Inc. |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 650 Larkfield Center, Suite C<br>Santa Rosa, CA 95403 |
| Phone Number: | 707-526-1335 x-224 |
| Fax Number: | 707-526-2022 |
| Contact Person: | Amy Conuel<br>Director Quality Assurance & Regulatory Affairs |
| Date Prepared: | July 8, 2008 |
| Trade Name: | Ensplint™ Bone Screw |
| Common Name: | Bone Screw |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Predicate Device: | Syntec-Taichung Non-Sterile Bone Plate and Screw<br>Implants. K983495, cleared 12/16/1998 |
| Device Description: | HA Cortical Self-Tapping Bone Screws in diameters of<br>1.5mm to 5.0mm and lengths of 4mm to 90mm. |
| Intended Use: | The Ensplint™ Bone Screws are intended to treat fractures<br>of various small and long bones. The Ensplint™ Bone<br>Screws can also be used with the EnsplintRx Distal Radius<br>System. |
| Rationale for Substantial<br>Equivalence / Comparison<br>to Predicate: | The Ensplint™ Bone Screw utilizes the same material and<br>technology characteristics as the Syntec Scientific Corp.<br>Bone Screws and conforms to the ASTM F543-2 Standard<br>Specification for HA Bone Screws. The diameters and<br>lengths are within the diameters and lengths of the predicate<br>Syntec Scientific Corp bone screws. Therefore testing is not<br>needed to demonstrate that the subject devices are<br>substantially equivalent to other legally marketed bone<br>screws. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sonoma Orthopedic Products, LLC % Ms. Amy Conuel Director, Quality Assurance/Regulatory Affairs 650 Larkfield Center, Suite C Santa Rosa, California 95403

JUL 1 0 2008

Re: K080778

Trade/Device Name: Ensplint™ Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: Class II Product Code: HWC Dated: June 24, 2008 Received: June 25, 2008

Dear Ms. Conuel:

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 (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.

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Page 2 - Ms. Amy Conuel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark H. Mullican

Mark N. Melkerson 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): K080778

Ensplint™ Bone Screw Device Name:

Indications for Use:

The Ensplint 114 Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Saubare Briehm Dformm

Division of General, Restorative, and Neurological Devices

519(1) Number K080728