AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm

K142528 · Agent Medical, LLC · HWC · Dec 22, 2014 · Orthopedic

Device Facts

• Record ID: K142528
• Device Name: AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm
• Applicant: Agent Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Dec 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Agent Medical ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones. The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes. The Agent Medical ArthroBridge System is not for spinal use.

Device Story

ArthroBridge System is a 2-piece cannulated compression screw system for intramedullary small joint arthrodesis/fusion and bone fixation in fingers and toes. Components include a threaded proximal module and a low-profile head screw. Device is inserted over a .035" K-wire into the phalangeal medullary canal. Threaded advancement of the screw into the stationary proximal module creates internal compression across the debrided joint space to stabilize bone and promote fusion. Used by surgeons in clinical settings for joint deformity correction and fracture fixation. Benefits include stabilization of small bones to facilitate healing. System includes disposable cannulated drills, guide wires, and driver/depth gauge instruments. Removal is percutaneous.

Clinical Evidence

No clinical data provided. Substantial equivalence determined via engineering and dimensional comparison to predicate devices.

Technological Characteristics

Two-piece cannulated compression screw system. Materials: Ti6Al4V ELI Titanium Alloy with Anodized Type II surface. Dimensions: Proximal module (4.0, 4.5, 5.0mm); Screw lengths (25-50mm). Sterilization: Ethylene Oxide. Single-use disposable instruments included.

Indications for Use

Indicated for patients requiring fixation of small bone fractures, osteotomy fixation, and distal phalangeal inter-digital fusion of fingers and toes. Contraindicated for spinal use.

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

• Integra/Kinetikos – KMI Kompressor™ Compression Screw (K024233 & K040356)
• BioPro - Kwick-Wire™ Universal Screw System (K130298)
• Nextremity - Nextra™ Hammertoe Correction System (K122031)
• Pioneer/Tornier – StayFuse™ Intramedullary Fusion Device (K990804)
• BioPro - Go-Ez™ Screw System (K081149)

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

December 22, 2014

Agent Medical, LLC % Mr. Al Lippincott Engineering Consulting Services, Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K142528

Trade/Device Name: Agent Medical - ArthroBridge System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 16, 2014 Received: October 28, 2014

Dear Mr. Lippincott:

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. Al Lippincott

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 yours.

### 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: DEVICE NAME: Agent Medical - ArthroBridge System

The Agent Medical ArthroBridge System is intended to facilitate bone healing following reduction and fracture fixation of the small bones.

The Agent Medical - ArthroBridge System is indicated for use for small bone fractures and osteotomy fixation and for distal phalangeal inter-digital fusion of the fingers and toes.

The Agent Medical - ArthroBridge System is not for spinal use.

Prescription Use XXXX -AND/OR Over-The-Counter-Use

(Per 21 CFR 801 Subpart D)

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

#### SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

| NAME OF FIRM: | Agent Medical, LLC<br>1145 Gaskins Road,<br>Suite 102<br>Richmond, VA 23238<br>USA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372<br>Tel. No. 952-492-5858<br>e-mail: [e-mail] |

- December 9, 2014 DATE:
TRADE NAME: Agent Medical – ArthroBridge System

- COMMON NAME: Intramedullary Bone and Compression Screw System
- Screw, Fixation, Bone DEVICE NAME:
- Smooth or Threaded Metallic Bone Fixation Fastener, CLASSIFICATION: Class II (21 CFR, Sec. 888.3040)

DEVICE PRODUCT CODE: HWC

| SUBSTANTIALLY<br>EQUIVALENT DEVICE | Integra/Kinetikos – KMI Kompressor™ Compression Screw<br>(K024233 & K040356)<br>BioPro - Kwick-Wire™ Universal Screw System (K130298)<br>Nextremity - Nextra™ Hammertoe Correction System (K122031)<br>Pioneer/Tornier – StayFuse™ Intramedullary Fusion Device (K990804)<br>BioPro - Go-Ez™ Screw System (K081149) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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#### DEVICE DESCRIPTION:

| | The Agent Medical - ArthroBridge System is an intramedullary small joint<br>arthrodesis/fusion system for fixation of osteotomies, fractures and<br>reconstruction of the phalanges of the lesser digits in the foot and hand.<br>The Agent Medical - ArthroBridge System is a 2-piece cannulated<br>compression screw system composed of 1). A threaded Proximal Module<br>(in a 4.0, 4.5 & 5.0mm size) that is placed within the proximal phalangeal<br>medullary canal, and 2). A Screw with low profile head (in lengths of 25,<br>30, 35, 40, 45 and 50mm) that is introduced/threaded into the previously<br>inserted Proximal Module. The Proximal Module is cannulated to fit over<br>an insertion instrument and the Screw is cannulated to fit over a .035" K-<br>wire for guided insertion of both components within the phalangeal digit<br>medullary canal. The threaded advancement of the Screw body within the<br>stationary threaded Proximal Module allows internal compression across<br>the debrided digit joint space for stabilization and eventual fusion/<br>arthrodesis – and for bone fixation and joint deformity correction. The<br>threaded Proximal Module and Screw with low profile head are<br>manufactured from high strength Ti6Al4V ELI Titanium Alloy with an<br>Anodized Type II surface. Disposable, single use, Cannulated Drills,<br>Guide Wires, and Driver/Depth Gauge instruments are available for<br>insertion of the system. Removal (when necessary) of the device is<br>carried out percutaneously. All Implants and Instruments are packaged |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 'Sterile' for single use. The method of sterilization is Ethylene Oxide. |
| INTENDED USE: | The Agent Medical - ArthroBridge System is intended to facilitate bone<br>healing following reduction and fracture fixation of the small bones.<br>The Agent Medical - ArthroBridge System is indicated for use for small<br>bone fractures and osteotomy fixation and for distal phalangeal inter-<br>digital fusion of the fingers and toes.<br>The Agent Medical ArthroBridge System is not for spinal use. |
| EQUIVALENCE: | The Agent Medical - ArthroBridge System is Substantially<br>Equivalent(SE) to the predicate systems (as listed). No nonclinical testing<br>was used in the determination of substantial equivalence. |
| SUMMARY OF TECH-<br>NOLOGICAL<br>CHARACTERISTICS | The Agent Medical - ArthroBridge System is Similar in Material,<br>Design, and Indications to the listed predicate devices. |
| CONCLUSION: | The Agent Medical - ArthroBridge System has similar indications for use,<br>materials, dimensions, and designs when compared to the predicate<br>devices. An engineering/dimensional comparison to the predicate devices<br>was performed to demonstrate Substantial Equivalence (SE). Based on<br>these similarities, the Agent Medical – ArthroBridge System is<br>substantially equivalent to the predicates identified in the 510(k) |