K Number
K061012
Device Name
AXSOS PLUS LOCKING PLATE SYSTEM
Date Cleared
2006-05-19

(37 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.
Device Description
This submission is a line extension to the Stryker® Locked Plating System for various types of locking plates. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System. The subject plates have locking and non-locking holes. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors.
More Information

Not Found

Not Found

No
The summary describes a mechanical device (bone plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical and FEA testing, not algorithm validation.

No.
Explanation: The device, a locking plate system, is used for fracture fixation, which is a supportive and stabilizing function, not a direct therapeutic healing or restorative action on the tissue itself.

No

This device, the AxSOS™ Plus Locking Plate System, is intended for "long bone fracture fixation," which clearly indicates a therapeutic or surgical purpose rather than a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition, not to treat it.

No

The device description clearly states it is a "Locking Plate System" and describes physical components like plates, screws, and Kirschner wires, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "for use in long bone fracture fixation." This describes a surgical implant used to stabilize broken bones within the body.
  • Device Description: The description details plates, screws, and Kirschner wires, which are all components of a surgical implant system.
  • Lack of IVD characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.

Therefore, the AxSOS™ Plus Locking Plate System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

Product codes

87 KTT, HRS

Device Description

This submission is a line extension to the Stryker® Locked Plating System for various types of locking plates. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System. The subject plates have locking and non-locking holes. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

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

FEA and mechanical testing was conducted to compare the strength of the new plates to the predicate plates. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

Key Metrics

Not Found

Predicate Device(s)

Not Found

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.

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K061012

510(k) Summary of Safety and Effectiveness AxSOSTM Plus Locking Plate System

Proprietary Name:AxSOS ™ Plus Locking Plate System
Common Name:Bone plates and screws
Classification Name/Reference:Single/multiple component metallic bone fixation
appliances and accessories, 21 CFR §888.3030
Device Product Code:87 KTT
Proposed Regulatory Class:
For Information contact:Class II
Francisco Haro, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:April 10, 2006

Description

This submission is a line extension to the Stryker® Locked Plating System for various types of locking plates. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System. The subject plates have locking and non-locking holes. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors.

Indications:

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

Substantial Equivalence:

The AxSOS™ Plus Locking Plate System is substantially equivalent to the Stryker® Locked Plating System in regards to intended use, design, materials, and operational principles as internal fixation components. FEA and mechanical testing was conducted to compare the strength of the new plates to the predicate plates. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

б

:

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Public Health Service ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2006

DEPARTMENT OF HEALTH & HUMAN SERVICES SECTION CONSULTION

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K061012

Trade/Device Name: AxSOS™ Plus Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 10, 2006 Received: April 12, 2006

Dear Mr. Haro:

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

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Page 2 – Mr. Francisco Haro

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Lemons

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: AxSOS™ Plus Locking Plate System

Indications for Use:

The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Device Evaluation (ODE)

Hubert Lense

Division Sign-O Division of General, Restora and Neurological Devices

510(k) Number K061012

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