Headless Compression Screw System

K143624 · Skeletal Dynamics, LLC · HWC · Jan 13, 2015 · Orthopedic

Device Facts

• Record ID: K143624
• Device Name: Headless Compression Screw System
• Applicant: Skeletal Dynamics, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jan 13, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Device Story

Headless Compression Screw System provides internal bone fixation. Device consists of cannulated titanium screws (2.5mm and 3.5mm diameters; 10mm-30mm lengths) and specialized instrumentation. Used by surgeons in clinical settings for fracture fixation, arthrodesis, and osteotomies. Screws are implanted to provide mechanical compression across bone fragments or joints to facilitate healing. System is provided non-sterile; requires sterilization by user facility. Output is physical stabilization of bone segments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including compression testing and ASTM F543 testing.

Technological Characteristics

Cannulated titanium bone screws; 2.5mm and 3.5mm diameters; 10mm-30mm lengths. Mechanical fixation principle. Provided non-sterile; requires facility-based sterilization. Testing performed per ASTM F543.

Indications for Use

Indicated for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies in patients requiring bone fixation.

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

• Skeletal Dynamics Headless Bone Screw (K112672)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

January 13, 2015

Skeletal Dynamics, LLC Ana M. Escagedo President 8905 SW 87 Avenue, Suite 201 Miami, Florida 33176

Re: K143624

Trade/Device Name: Headless Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 19, 2014 Received: December 22, 2014

Dear Ms. Ana M. Escagedo:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Ana M. Escagedo

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" (21CFR 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 vours.

# Lori A. Wiggins -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

510(k) Number (if known): K143624

Device Name: Headless Compression Screw System

Indications For Use: The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:

Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of four green shapes that are arranged to form a square. The company name, "skeletal dynamics", is written in a sans-serif font to the right of the graphic. The word "skeletal" is on the top line and the word "dynamics" is on the bottom line.

### 510(k) Summary of Safety and Effectiveness Skeletal Dynamics Headless Compression Screw System

December 19, 2014

### Submitter:

Skeletal Dynamics. LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: [phone] Fax: [phone] Contact: Ana M. Escagedo, President Email: [e-mail]

Establishment Registration Number: 3006742481

#### Trade Name, Common Name, Classification:

| Trade Names | Headless Compression Screw System |
|----------------|-----------------------------------|
| Common Name | Screw, fixation, bone |
| Classification | 21 CFR §888.3040 |
| Product Code | HWC |
| Class | Class II |

### Predicate Devices:

Skeletal Dynamics Headless Bone Screw (K112672)

### Description of the Device:

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm.

The system is provided non-sterile and is sterilized in the user facility.

### Intended Use:

The Skeletal Dynamics Headless Compression Screw is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:

Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius

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fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

#### Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.

### Performance Testing:

Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements. The subject device is as safe and effective as legally marketed predicate devices.