K Number
K082833
Device Name
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
Date Cleared
2009-02-05

(132 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.
Device Description
The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.
More Information

Not Found

No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or AI/ML capabilities.

No
The device, an external fixator, is used to stabilize fractures until healing occurs. This is a structural support function, not a therapeutic treatment of a disease or condition.

No
The device is described as an external fixator used for the fixation of bone fractures until healing, which is a therapeutic rather than a diagnostic function.

No

The device description explicitly states it consists of a "body" and "threaded pins," which are physical hardware components, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The NBXTM Non-Bridging External Fixator - Shoulder is a surgical implant used to stabilize bone fractures. It is applied directly to the body and does not involve the analysis of bodily specimens.
  • Intended Use: The intended use clearly states it's for "external fixation, until healing" of bone fractures. This is a therapeutic and structural function, not a diagnostic one.

Therefore, based on the provided information, this device falls under the category of a surgical implant or external fixation device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The NBXTM Non-Bridging External Fixator – Shoulder, is used for external fixation, until healing, of open or closed fractures, mal-union, and nonunions of the proximal end of the humerus, to include sub-capital and/or fractures of the humeral head.

The NBX™ Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.

Product codes

KTT, LXT

Device Description

The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

proximal end of the humerus, to include sub-capital and/or fractures of the humeral head.

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

Non-Clinical performance data: Equivalence to accepted methods of treatment for this products indication of use is covered in other sections of this application.

Key Metrics

Not Found

Predicate Device(s)

K070561, K052605

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

0

KOB2B33 (ps 1/2)

510(k) Summary

Name of Sponsor:

510(k) Contact:

Proprietary Name:

Common Name:

Classification:

Device Product Code:

Substantially Equivalent Devices:

Non-Clinical performance data:

NUTEK Orthopaedics, Inc. 301 SW 7th Street Ft. Lauderdale, FL 33301

Peter Mincieli Vice President Operations 301 SW 7th Street Ft. Lauderdale, Florida 33315 peter@nutekortho.com Phone Office: (954) 312-8826 Phone Mobile: (954) 818-9204 Fax: (954) 495-8021

NBXTM Non-Bridging External Fixator - Shoulder

External Fixation Devices - Bone Fixation Fasteners

Class II per 21 CFR 888.3030; Multiple component metallic bone fixation Appliances and accessories

KTT - LXT

KMedic - K070561 - Smooth or Threaded metallic bone fixation fastener GexFix - K052605 - Smooth or Threaded metallic bone fixation fastener

Equivalence to accepted methods of treatment for this products indication of use is covered in other sections of this application.

Section 2 - page 1 of 2

FEB - 5 2009

1

K082833 (pg 2/2)

510(k) Summary

continued

Device Description

Intended Use:

The NBXTM Non-Bridging Fixator – Shoulder is provided sterile. The fixator consists of the body and with its proprietary locking mechanism and a multiple of threaded pins.

The NBXTM Non-Bridging External Fixator – Shoulder, is used for external fixation, until healing, of open or closed fractures, mal-union, and nonunions of the proximal end of the humerus, to include sub-capital and/or fractures of the humeral head.

316LVM Stainless Steel (per ASTM F 138). Lexan HPS1R – complies with FDA Reg 21 CFR 177.1580

Material:

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three ribbons flowing from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

FEB - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nutek Orthopaedics, Inc. % Mr. Peter Mincielli Vice President of Operations 16771 SW 6th St. Pembroke Pines, FL 33027

Re: K082833

Trade/Device Name: NBX™ Non-Bridging External Fixator - Shoulder Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: KTT, LXT Dated: January 23, 2009 Received: January 28, 2009

Dear Mr. Mincielli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

3

Page 2 - Mr. Peter Mincielli

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

K082833 (pg 1/1)

Indications for Use

510(k) Number (if known): K082833

Device Name: The NBX™ Non-Bridging External Fixator - Shoulder

Indications For Use:

The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division & Division of General, Restorative. and Neurolo cal Devices

510(k) Number 108285