J-SCREW COMPRESSION SCREW

K130019 · Competitive Engineering, Inc. · HWC · Nov 18, 2014 · Orthopedic

Device Facts

• Record ID: K130019
• Device Name: J-SCREW COMPRESSION SCREW
• Applicant: Competitive Engineering, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.

Device Story

J-Screw is a two-part metallic bone screw; designed for small bone fixation in upper and lower extremities. Device enables infinitely adjustable compression for fusion in fixed or flexed positions. Used by orthopedic surgeons in clinical settings for osteotomy, reconstruction, arthrodesis, joint fusion, and fracture repair. Provides mechanical stabilization of bone segments to facilitate healing. Performance verified via torque, torsional yield, breaking angle, and axial pullout testing per ASTM standards.

Clinical Evidence

Bench testing only. Performance data gathered for insertion/removal torque, torsional yield strength, maximum torque, breaking angle, axial pullout strength (per ASTM F543-13), and static cantilever bending force.

Technological Characteristics

Two-part metallic bone fixation fastener. Threaded design. Mechanical performance testing conducted per ASTM F543-13. No software or electronic components.

Indications for Use

Indicated for osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.

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

• StayFuse (K990804)
• FlexFusion Fixation implant (K110445)
• Nextra Ti Hammertoe Correction System (K122031)
• Arthrex K-Wire (K052736)

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

November 18, 2014

Competitive Engineering, Incorporated David M. Davis Engineering Manager 3371 East Hemisphere Loop Tucson, Arizona 85706

Re: K130019 Trade/Device Name: J-Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 24, 2014 Received: September 30, 2014

Dear Mr. Davis:

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 - Mr. David M. Davis

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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## 5. Indications for Use Statement

K130019 page 1 of 1

#### J-Screw Intended Use:

The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 6. 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the J-Screw is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) Summary.

| Applicant: | Competitive Engineering, Inc. |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 3371 E. Hemisphere Loop<br>Tucson, AZ 85706 |
| Contact Person: | David M. Davis |
| Telephone: | 520-746-0270 X-106 |
| Fax: | 520-746-0481 |
| Preparation Date: | November 13, 2014 |
| Device Trade Name: | J-Screw |
| Common Name: | Compression screw |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Regulatory Class;<br>Legally Marketed<br>Predicates: | StayFuse (K990804)<br>FlexFusion Fixation implant (K110445)<br>Nextra Ti Hammertoe Correction System (K122031)<br>Arthrex K-Wire (K052736) |
| Device Description: | The J-Screw is a two part bone screw for use in<br>osteotomy, reconstruction, arthrodesis, joint fusion,<br>fracture repair, and fracture fixation of small bones of the<br>upper and lower extremities. The unique design of the<br>device allows it to fixate or fuse small bones with<br>infinitely adjustable fusing compression, in a fixed yet<br>flexed position. |
| Intended Use: | The J-Screw is indicated for use in osteotomy,<br>reconstruction, arthrodesis, joint fusion, fracture repair,<br>and fracture fixation of small bones of the upper and<br>lower extremities. |
| Performance Data: | Performance data gathered for insertion and removal<br>torque, torsional yield strength, maximum torque,<br>breaking angle, as well as axial pullout strength was<br>gathered as outlined by ASTM F543-13 with qualified<br>processes and material. Performance data gathered for<br>static cantilever bending force submitted with test<br>outline. |
| Conclusion: | The J-Screw possesses the same technologic<br>characteristics of the predicate devices. These<br>characteristics include the intended use, basic threaded<br>design, material, size as specified by medical<br>professionals, and fundamental technology. The J-Screw<br>is substantially equivalent to the predicate bone fixation<br>devices. |

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510(k) Summary of Safety and Effectiveness for the J-Screw continued: