(81 days)
Not Found
No
The document describes a mechanical external fixation system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an external fixation system used for the treatment and fixation of various medical conditions, including fractures, joint contractures, limb lengthening, and deformity correction, all of which are considered therapeutic interventions.
No
Explanation: The device description states it is an external fixation device used for treatment and fixation of fractures, deformities, and for limb lengthening. Its intended use is therapeutic (fixation, correction, lengthening) rather than diagnostic (identifying or characterizing a condition).
No
The device description explicitly lists numerous hardware components such as rings, rods, struts, bolts, and wires, indicating it is a physical external fixation system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device used for the fixation and manipulation of bones and soft tissues in the body (fractures, fusions, limb lengthening, deformity correction, etc.). This is a surgical or orthopedic device, not a diagnostic one.
- Device Description: The description details the physical components of an external fixation system (rings, rods, struts, bolts, wires, etc.). These are mechanical components used to stabilize and manipulate the skeletal structure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) to provide 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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified telescopic strut and wire bolt components of the Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in K113327. 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. 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 Testing: Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components. 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 modified components are substantially equivalent to the predicate device components previously cleared in K113327. Testing included the following:
Telescopic Strut
- Dynamic and Static Component Testing
- Dynamic and Static Construct Testing
Wire Bolt
- Dynamic Construct Testing
- Pull Out Testing
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.
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
K130334
510(k) Summary
External Fixation Device
Proprietary Name:
Hoffmann LRF (Limb Reconstruction Frame) System
Common Name:
.
.
Classification Name and Reference: Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030
Regulatory Class:
Product Codes:
Sponsor:
Contact Information:
Class II
87 KTT-Appliance, fixation, nail/blade/plate combination, multiple component
Stryker Trauma AG Bohnackerweg I 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:
February 7, 2013
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified telescopic strut and wire bolt components of the Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in K113327. 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. 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.
1
K130334
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
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 .
- Ilizarov External Fixation System (K031181-Smith and Nephew) .
2
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components. 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 modified components are substantially equivalent to the predicate device components previously cleared in K113327. Testing included the following:
Telescopic Strut
- Dynamic and Static Component Testing .
- Dynamic and Static Construct Testing .
Wire Bolt
- . Dynamic Construct Testing
- Pull Out Testing .
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Stryker Trauma AG % Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K130334
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 8, 2013 Received: . April 9, 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, listing 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 (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.
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/Industrv/default.htm.
Sincerely yours,
Erin - Meith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K130334
Indications for Use
510(k) Number (if known):
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 .
- 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 t
- Fusions and replantations of the foot .
- Charcot foot reconstruction .
- Lisfranc dislocations .
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
107