Anjon Bremer Halo System

K171863 · Anjon Holdings, LLC · JEC · Mar 19, 2018 · Orthopedic

Device Facts

• Record ID: K171863
• Device Name: Anjon Bremer Halo System
• Applicant: Anjon Holdings, LLC
• Product Code: JEC · Orthopedic
• Decision Date: Mar 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

Device Story

System provides cervical spine immobilization and therapeutic traction; consists of transcutaneous titanium threaded skull pins, aluminum crown/ring, aluminum rod superstructure, and lined polymer vest. Pins attach to skull; crown/ring positioned below head equator; superstructure connects to vest or surgical table via Mayfield adaptor. Used in clinical/surgical settings by physicians. Fixation achieved by tightening pins to specified torque; frame maintains head in extension to eliminate rotation/flexion. MRI/CT conditional. Benefits patient by stabilizing cervical spine during treatment or diagnostic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance data comparisons and technological characteristic analysis.

Technological Characteristics

Materials: 356-T-6 aluminum, Wrought Titanium-6Aluminum-4Vanadium ELI, Aluminum 6061-T6, Nylon 66 resin (50% Long Glass), Resinol type A (LDPE). Components: skull pins, crown/ring, rod superstructure, polymer vest. MRI/CT conditional. Non-sterile. Mechanical fixation via torque-limited threaded pins.

Indications for Use

Indicated for patients with cervical trauma or other neck conditions requiring cervical spine immobilization and therapeutic traction.

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

• Bremer Halo System Cervical Traction Skull Pin (K915800)

Reference Devices

• Bremer Halo System Titanium Skull Pin (K993099)

Submission Summary (Full Text)

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March 19, 2018

Anjon Holdings, LLC % Mr. John Kapitan Chief Executive Officer Kapstone Medical P.O. Box 969 Leicester, North Carolina 28748

Re: K171863

Trade/Device Name: Anjon Bremer Halo System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: March 9, 2018 Received: March 12, 2018

Dear Mr. Kapitan:

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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#### Page 2 - Mr. John Kapitan

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -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) K171863

Device Name Anjon Bremer Halo System

Indications for Use (Describe)

The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

Type of Use (Select one or both, as applicable)

| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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Image /page/3/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is in a serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, sans-serif font, with a blue line above and below the word.

# 510(k) Summary

# 1. Applicant

Anjon Holdings, LLC 4801 Dawin Rd Jacksonville, FL 32207

#### 2. Official Correspondent

Kapstone Medical, LLC PO Box 969 Leicester, NC 28748

#### Contact Person:

John Kapitan, CEO Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. Date Prepared:

19 June 2017

#### 4. Device Name

Trade: Anjon Bremer Halo System Common/Usual Name: External fixator system Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 888.3040 Product Code: JEC Classification: II Panel: Orthopedic

#### 5. Predicate Devices

The Anjon Bremer Halo System is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin produced by Bremer Medical, Inc and the Bremer Halo System Titanium Skull Pin produced by DePuy Acromed, marketed as Bremer Halo System. The Bremer Halo System Cervical Traction Skull Pin is the Primary Predicate and the Bremer Halo System Titanium Skull Pin is a Reference Predicate, as shown below with corresponding 510(k) numbers.

| Predicate | 510(k) Number | Device | Manufacturer |
|-----------|---------------|------------------------------------------------|---------------------|
| Primary | K915800 | Bremer Halo System Cervical Traction Skull Pin | Bremer Medical, Inc |
| Reference | K993099 | Bremer Halo System Titanium Skull Pin | De Puy Acromed |

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Image /page/4/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is displayed in a stylized font, with the "A" in blue and the rest of the letters in black. Below "Anjon" is the word "Holdings" in a smaller, blue font, with a line above and below the word. The logo has a clean and professional look.

### 6. Description of the Device

The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements, and extracutaneous bridge elements, which provide fixation of the torso to immobilize the cervical spine when used with a frame or surgical table adaptor.

The transcutaneous bone anchorage elements are titanium threaded skull pins, of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor. All materials are MRI/CT conditional.

Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.

## 7. Indications for Use

The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.

#### 8. Summary of Technological Characteristic Comparison

The technological characteristics of the Anjon Bremer Halo System are equivalent to the predicate devices, as outlined in Table 1-2 below.

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Image /page/5/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, sans-serif font, with a blue line above and below it. The logo has a clean and professional look.

#### Traditional 510(k) Submission: Anjon Bremer Halo System

| Applicant | Anjon LLC | Bremer Medical, Inc | De Puy Acromed |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
| Product Name | Anjon Bremer Halo<br>System | Bremer Halo System<br>Cervical Traction Skull<br>Pin | Bremer Halo System<br>Titanium Skull Pin |
| 510(k) Number | TBD | K915800 | K993099 |
| Product Code | JEC | JEC | JEC, HWC |
| Regulation # | 21CFR 888.3040 | 21CFR 888.3040 | 21CFR 888.3040 |
| Class | II | II | II |
| Prescription or O-<br>T-C? | Prescription | Prescription | Prescription |
| Provided Sterile or<br>Non-sterile? | Non-sterile | Sterile | Sterile |
| Indications for Use | Intended for use to<br>provide cervical spine<br>immobilization and<br>therapeutic traction<br>for treatment of<br>patients with cervical<br>trauma or other neck<br>condition | Intended for use to<br>provide cervical spine<br>immobilization and<br>therapeutic traction<br>for treatment of<br>patients with cervical<br>trauma or other neck<br>condition | Intended for use in<br>conjunction with<br>Bremer's Halo System<br>cervical traction<br>devices and<br>accessories, which<br>provide cervical<br>immobilization for<br>treatment of patients<br>for healing and<br>rehabilitation of<br>cervical spinal cord<br>injuries |
| Components | Crown (Metal)<br>Adjustable Ring (Metal)<br>Positioning Pins<br>(Polymer)<br>Positioning Pads<br>(Polymer)<br>Plastic molded vest<br>(Polymer)<br>Vest liner (synthetic<br>lambskin)<br>Rod superstructure<br>(metal) with halo clamps<br>(polymer)<br>Threaded screw skull pin<br>(Alloy)<br>Torque Limiter (Polymer) | Halo Crown (Metal)<br>Adjustable Halo Ring<br>(Metal)<br>Positioning Pins<br>(Polymer)<br>Positioning Pads<br>(Polymer)<br>Plastic molded vest<br>(Polymer)<br>Vest liner (synthetic<br>lambskin)<br>Rod superstructure<br>(metal) with halo clamps<br>(polymer)<br>Threaded screw skull pin<br>(Alloy) | Halo Crown (Metal)<br>Adjustable Halo Ring<br>(Metal)<br>Positioning Pins<br>(Polymer)<br>Positioning Pads<br>(Polymer)<br>Plastic molded vest<br>(Polymer)<br>Vest liner (synthetic<br>lambskin)<br>Rod superstructure<br>(metal) with halo clamps<br>(polymer)<br>Threaded screw skull pin<br>(Alloy)<br>Torque Limiter (Polymer) |

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Image /page/6/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, sans-serif font, with a blue line above and below it. The logo is simple and professional, and the blue color gives it a sense of trustworthiness.

#### Traditional 510(k) Submission: Anjon Bremer Halo System

| Applicant | Anjon LLC | Bremer Medical, Inc | De Puy Acromed |
|------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
| Product Name | Anjon Bremer Halo<br>System | Bremer Halo System<br>Cervical Traction Skull<br>Pin | Bremer Halo System<br>Titanium Skull Pin |
| Accessories | Torque wrench<br>Head spoon<br>ICU Fast Release Bolts<br>Mayfield Adapter Set | Torque wrench<br>Head spoon<br>ICU Fast Release Bolts<br>Mayfield Adapter Set | Not applicable |
| Sterilization<br>Methodology | Not applicable | Ethylene Oxide | Ethylene Oxide |
| MRI Safety | MR Conditional | MRI Compatible | MRI Compatible |

Table 1-2: Overview of Substantial Equivalence

#### 9. Conclusion

The Anjon Bremer Halo System is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin predicate device (Primary Predicate - K915800) and Bremer Halo System Titanium Skull Pin (Reference predicate - K993099). In addition to conclusions from performance data comparisons, the devices have the same "Indications for Use," and are available by prescription only, and are for single use only. The devices utilize 356-T-6 aluminum, Wrought Titanium-6Aluminum-4Vanadium ELI, Aluminum 6061-T6, Nylon 66 resin containing 50% Long Glass, and Resinol type A (LPDE). It can be concluded that the Anjon Bremer Halo System is substantially equivalent to the predicate device.