K Number

Device Name

Anjon Bremer Halo System

Manufacturer

Anjon Holdings, LLC

Date Cleared

2018-03-19

(270 days)

Product Code

JEC

Regulation Number

888.3040

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K915800, K993099

Reference Devices

K993099

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical device for cervical spine immobilization and traction, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is indicated for "therapeutic traction for treatment of patients with cervical trauma or other neck condition," which implies a therapeutic purpose.

Diagnostic

The device is used for immobilization and traction, which are therapeutic rather than diagnostic actions. It addresses a medical condition but does not provide information to identify a disease or condition.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including bone anchorage elements, bridge elements, skull pins, crown/ring, rod superstructure, vest, and surgical table adaptor.

IVD (In Vitro Diagnostic)

Based on the provided information, the Anjon Bremer Halo System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions. This is a therapeutic and mechanical support function, not a diagnostic one.
Device Description: The device consists of physical components (pins, rings, rods, vest) used to physically stabilize the cervical spine. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Lack of IVD Indicators: The description does not mention any elements typically associated with IVD devices, such as:
- Analysis of biological samples.
- Measurement of biomarkers or analytes.
- Diagnostic information provided to a healthcare professional.

The Anjon Bremer Halo System is a Class II medical device used for external fixation and support of the cervical spine.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

JEC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine, neck, skull

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K915800, K993099

Reference Device(s)

K993099

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

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);

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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: (704) 843-7852 Fax: (704) 831-5316 Email: jkapitan@kapstonemedical.com

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

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

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.

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
System	Bremer Halo System
Cervical Traction Skull
Pin	Bremer Halo System
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-
T-C?	Prescription	Prescription	Prescription
Provided Sterile or
Non-sterile?	Non-sterile	Sterile	Sterile
Indications for Use	Intended for use to
provide cervical spine
immobilization and
therapeutic traction
for treatment of
patients with cervical
trauma or other neck
condition	Intended for use to
provide cervical spine
immobilization and
therapeutic traction
for treatment of
patients with cervical
trauma or other neck
condition	Intended for use in
conjunction with
Bremer's Halo System
cervical traction
devices and
accessories, which
provide cervical
immobilization for
treatment of patients
for healing and
rehabilitation of
cervical spinal cord
injuries
Components	Crown (Metal)
Adjustable Ring (Metal)
Positioning Pins
(Polymer)
Positioning Pads
(Polymer)
Plastic molded vest
(Polymer)
Vest liner (synthetic
lambskin)
Rod superstructure
(metal) with halo clamps
(polymer)
Threaded screw skull pin
(Alloy)
Torque Limiter (Polymer)	Halo Crown (Metal)
Adjustable Halo Ring
(Metal)
Positioning Pins
(Polymer)
Positioning Pads
(Polymer)
Plastic molded vest
(Polymer)
Vest liner (synthetic
lambskin)
Rod superstructure
(metal) with halo clamps
(polymer)
Threaded screw skull pin
(Alloy)	Halo Crown (Metal)
Adjustable Halo Ring
(Metal)
Positioning Pins
(Polymer)
Positioning Pads
(Polymer)
Plastic molded vest
(Polymer)
Vest liner (synthetic
lambskin)
Rod superstructure
(metal) with halo clamps
(polymer)
Threaded screw skull pin
(Alloy)
Torque Limiter (Polymer)

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
System	Bremer Halo System
Cervical Traction Skull
Pin	Bremer Halo System
Titanium Skull Pin
Accessories	Torque wrench
Head spoon
ICU Fast Release Bolts
Mayfield Adapter Set	Torque wrench
Head spoon
ICU Fast Release Bolts
Mayfield Adapter Set	Not applicable
Sterilization
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.