(70 days)
No
The device description and intended use focus on mechanical components for external fixation and limb reconstruction. There is no mention of AI, ML, or any software-driven analytical capabilities.
Yes.
The device is used for the treatment and fixation of various injuries and conditions, including fractures, contractures, limb lengthening, and deformity correction, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an external fixation system used for the treatment and fixation of various fractures and deformities, as well as for limb lengthening. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists numerous hardware components (rings, rods, struts, bolts, pins, etc.) and the performance studies describe physical testing of these components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment and fixation of fractures, deformities, and other musculoskeletal conditions. This involves direct interaction with the patient's body for structural support and correction.
- Device Description: The device description details an external fixation system composed of rings, rods, struts, pins, and other mechanical components. These are physical devices used to stabilize and manipulate bones and soft tissues externally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived 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 (within or on the body) for structural support and manipulation.
N/A
Intended Use / Indications for Use
The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and Closed Fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion.
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones.
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformity.
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis.
- Management of comminuted intra-articular fractures of the distal radius.
The Stryker Hoffmann LRF System is indicated in adults for:
- Osteotomy
- Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures.
- Fusions and replantations of the foot.
- Charcot foot reconstruction.
- Lisfranc dislocations.
Product codes
KTT
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in KI 13327. The Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. The additional components will consist of the following: carbon foot ring, foot arch, hinge coupling and compatibility with the previously cleared Hoffmann 3 couplings. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins. Hoffmann II External Fixation 90° Post. Carbon Connecting Rod and Miami Post.
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
pediatric patients and adults
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)
Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the additional components and component compatibility. Testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components. Testing included the following:
- Static Cantilever Bending Test-Carbon Foot Ring
- Static Compression Test- Foot Arch
- Static Cantilever Test-Hinge Coupling
- Dynamic Test-Frame Construct
- Compatibility Engineering Evaluation
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K130907 (1/3)
510(k) Summary
External Fixation Device
JUN 1 0 2013
Proprietary Name:
Common Name:
Classification Name and Reference:
Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR $888.3030
Hoffmann LRF (Limb Reconstruction Frame) System
Regulatory Class:
Class II
Product Codes:
Sponsor:
Contact Information:
Class II
KTT-Appliance, fixation, nail/blade/plate combination, multiple components
Stryker Trauma AG Bohnackerweg 1 CH-2545 Selzach Switzerland
Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com
Date Prepared:
March 28, 2013
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in KI 13327. The Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. The additional components will consist of the following: carbon foot ring, foot arch, hinge coupling and compatibility with the previously cleared Hoffmann 3 couplings. This external fixation system may also be used with
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1
the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins. Hoffmann II External Fixation 90° Post. Carbon Connecting Rod and Miami Post.
Intended Use:
The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults
Indications:
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:
- . Open and Closed Fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones .
- . Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformity .
- Correction of segmental bony or soft tissue defects .
- Joint arthrodesis .
- Management of comminuted intra-articular fractures of the distal radius .
The Stryker Hoffmann LRF System is indicated in adults for:
- Osteotomy .
- Revision procedure where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction .
- Lisfranc dislocations .
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30
Summary of Technologies:
Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:
- Hoffmann LRF (Limb Reconstruction Frame) System- K113327 .
- . External Fixation System (Smith and Nephew)- K031181
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the additional components and component compatibility. Testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components. Testing included the following:
- Static Cantilever Bending Test-Carbon Foot Ring .
- Static Compression Test- Foot Arch .
- Static Cantilever Test-Hinge Coupling .
- . Dynamic Test-Frame Construct
- . Compatibility Engineering Evaluation
Clinical Testing: Clinical testing was not required for this submission.
Conclusion: The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human figures or profiles stacked on top of each other, creating a sense of unity and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2013
Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K130907
Trade/Device Name: Hoffmann LRF (Limb Reconstruction Frame) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: April 11, 2013 Received: April 12, 2013
Dear Ms. Celi:
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. Iisting 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 (reporting of medical
4
Page 2 - Ms. Estela Celi
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows the name "Erin Keith" in a stylized font. The first name, "Erin," is written in a simple, bold font. The last name, "Keith," is written in a more complex, decorative font. The two names are connected by a stylized design.
For
Mark N. Melkerson
Director-Division of Orthopedic Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130907
Device Name: Hoffmann LRF (Limb Reconstruction Frame) System
Indications for Use:
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and Closed Fractures .
- . Post-traumatic joint contracture which has resulted in loss of range of motion
- Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones .
- Limb lengthening by epiphyseal or metaphyseal distraction .
- Correction of bony or soft tissue deformity t
- Correction of segmental bony or soft tissue defects .
- Joint arthrodesis .
- Management of comminuted intra-articular fractures of the distal radius .
The Stryker Hoffmann LRF System is indicated in adults for:
- . Osteotomy
- · Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction .
- Lisfranc dislocations .
Over-The-Counter Use Prescription Use X 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)
Image /page/5/Picture/23 description: The image shows the text "Casey L. Hanley, Ph.D." above a horizontal line. Below the line, the text "Division of Orthopedic Devices" is displayed. The text appears to be part of a letterhead or official document.
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