(7 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical external fixation system and does not mention any AI or ML components or functionalities.
No
The device is used to provide stabilization of fractures, which is a structural support function rather than a therapeutic or diagnostic treatment.
No
The device is an external fixation system used for stabilizing fractures, not for diagnosing medical conditions. Its intended use is mechanical support, not diagnostic assessment or information generation.
No
The device description clearly states it is an "External Fixation System" and a "line extension intended to add an alternate style of coupler". This indicates a physical, hardware-based medical device used for stabilizing fractures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization of open and/or unstable fractures." This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on adding a "coupler" to an external fixation system, which is a mechanical device used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) to treat fractures.
N/A
Intended Use / Indications for Use
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile and nonsterile external fixation frames intended to provide stabilization of open and/or unstable fractures. The indications for use for the Hoffmann® II Rod to Wire Coupling are provided below.
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex" Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX " External Fixation System.
This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
87 KTT
Device Description
This Special 510(k) submission is a line extension intended to add an alternate style of coupler to the Hoffmann® II External Fixation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K05349 p½
DEC 9 2005
Summary of Safety and Effectiveness Hoffmann® II Rod to Wire Coupling
| Proprietary Name: | Hoffmann® II Rod to Wire Coupling |
|---|---|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone |
| fixation appliances and accessories, 21 CFR | |
| §888.3030 | |
| Device Product Code: | 87 KTT |
| For Information contact: | 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: | December 1, 2005 |
Description:
This Special 510(k) submission is a line extension intended to add an alternate style of coupler to the Hoffmann® II External Fixation System.
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile and nonsterile external fixation frames intended to provide stabilization of open and/or unstable fractures. The indications for use for the Hoffmann® II Rod to Wire Coupling are provided below.
Indications for Usc:
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex" Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX " External Fixation System.
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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'K053349 r/2'. The characters are written in a cursive style, and the contrast between the ink and the background is high, making the text easily readable.
This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.
Substantial Equivalence:
The subject Hoffmann® II Rod to Wire Coupling shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol with three parallel lines that curve and converge at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.
DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Francisco Haro Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K053349
K053349
Trade/Device Name: Hoffmann® II Rod to Wire Coupling Regulation Number: 21 CFR 888.3030 Regulation Number: 21 CFR 886.5030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 30, 2005 Received: December 2, 2005
Dear Mr. Haro:
We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication were and the clearing is substantially equivalent (for the indica We have reviewed your Section > IQK) premaise in substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have deemined the levices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally interest declical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactions of the Federal Food, Drug, devices that have been reclassified in accounted with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls You may, therefore, market the device, subject or the general registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Incrude requirements of the samally and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito entitle cass if creasur som alleoting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional controls: Listing major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, This 24, 2017
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 Please be advised that FIAA's ssuance of a substantial with other requirements of the Act
that FDA has made a determination that your device complies with other requirements. that FDA has made a determination in a your device complet Federal agencies. You must
or any Federal statutes and regulations administered by registration and listing or any Federal statutes and regulations and united to: registration and listing (21 list.
comply with all the Act's requirements, including, but not ice reguirements as sct comply with all the Act 5 requirements, including, out manufacturing practice requirements as sch
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the d CFR Part 807); labeling (21 CFR Parl 801), good manifacture, policable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, 1050 forth in the quality systems (QS) regulation (21 -51 re reases)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Francisco Haro
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maketing of substantial equivalence of your device to a legally premarket notheation. THC PDA miding of cassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our lateling regulation (11 CFR Part 801), please If you desire specific advice for your do not one one one the regulation entitled, the regulation entitled, the open abtering contact the Office of Comphalled at (210) = 16 = 21 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misbranding by reference to premation notifications in the Act from the Division of Small other gelleral information on your responsive at its toll-fire number (800) 638-2041 or 1988)
Manufacturers, International and Consumer Assistance at in him between worldings Manufacturers, International and Consumer Abstrance arov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KOS 3349
Device Name: Hoffmann® II Rod to Wire Coupling
Indications for Use:
:
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the The Tionnalir - 11 17 Joria External Fixation System and Kirschner Wires of the Monticelli Pipel "Tall " External Fixation System, and may be used as a Hybrid External Fixation System with the Spinch - External Pixation System, and the Monotube® TRIAX™ External Fixation System.
This device is used to provide stabilization of open and/or unstable fractures and where soft r ms device is used to pro ria ease of other fracture treatments such as IM rods, casts, or other means of internal fixation.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(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)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K053349 |
|---|---|
| --------------- | --------- |
35