(23 days)
Not Found
No
The summary describes a mechanical device (external fixator) and does not mention any software, algorithms, or AI/ML capabilities. The submission is for a line extension (adding a connecting tube) to an existing predicate device.
Yes
The device is intended for complete and temporary fracture fixation, indicating its use in treating a medical condition or disease.
No
The device description and intended use indicate that the Hoffmann Xpress Line Extension is for "complete and temporary fracture fixation" and other bone procedures, which are therapeutic interventions, not diagnostic ones. It helps treat conditions rather than identify them.
No
The device description explicitly states the addition of physical components (connecting tubes) to a predicate hardware system for fracture fixation. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "complete and temporary fracture fixation for long bones and pelvis fractures." This describes a surgical device used to stabilize bones within the body.
- Device Description: The device is described as "connecting tubes" for a "fracture fixation system." This further reinforces its role as a surgical implant/device.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information provided describes a medical device used for orthopedic surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Hoffmann Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:
- Bone fracture fixation; .
- . Osteotomny;
- Arthodesis; .
- Correction of deformity; .
- Revision procedures where other treatments or devices have been unsuccessful; .
- Bone reconstruction procedures. .
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
This Special 510(k) submission is intended to addition of 500mm (length)/15mm (diameter) connecting tubes to the predicate Hoffmann Light System, now known as Hoffmann Xpress System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones and pelvis
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)
Functional and mechanical testing demonstrates the comparable mechanical and functional properties of the subject Hoffmann Xpress Line Extension to the predicate device Hoffmann Xpress (Light) System K073076.
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.
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
Special 510(k)
X092834
510(k) Summary of Safety and Effectiveness: HOFFMANN XPRESS LINE EXTENSION
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
For Information contact:
:
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
OCT - 8 2009
Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116
Date Summary Prepared:
Device Identification Proprietary Name:
Common Name: Classification Name and Reference:
Device Product Code:
September 14, 2009
Hoffmann Xpress Line Extension
External fixation frame components Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030 KTT
Description:
This Special 510(k) submission is intended to addition of 500mm (length)/15mm (diameter) connecting tubes to the predicate Hoffmann Light System, now known as Hoffmann Xpress System.
Intended Use:
The Hoffmann Xpress Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications for use for the subject tubes are provided below.
Indications for Use:
The Hoffmann® Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:
- Bone fracture fixation; .
- :":": ● Osteotomny;
- Arthodesis; .
- Correction of deformity; .
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- Revision procedures where other treatments or devices have been unsuccessful; .
- . Bone reconstruction procedures.
Statement of Technological Comparison:
The subject and predicate devices are made from an aluminum alloy (AlMgSi) and Linear Low Density Polyethylene (LLDPE). Functional and mechanical testing demonstrates the comparable mechanical and functional properties of the subject Hoffmann Xpress Line Extension to the predicate device Hoffmann Xpress (Light) System K073076.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
OCT - 8 2009
Re: K092834
Trade/Device Name: Hoffmann Xpress System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 14, 2009 Received: September 15, 2009
Dear Ms. Matarese:
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 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Melissa A. Matarese
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): #
Device Name: Hofmann Xpress Linc Extension
Indications For Use:
The Hoffmann Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:
- Bone fracture fixation; .
- . Osteotomny;
- Arthodesis; .
- Correction of deformity; .
- Revision procedures where other treatments or devices have been unsuccessful; .
- Bone reconstruction procedures. .
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Doneta der MXN
vision Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092834