(294 days)
Synthes Distraction Osteogenesis System, Synthes Large External Fixation, MR Conditional
Not Found
No
The device description and performance studies focus on mechanical components, materials, and MR compatibility, with no mention of AI or ML.
Yes
The device is described as an external ring fixation system intended for fracture fixation, limb lengthening, and correction of deformities. These are all therapeutic actions.
No
Explanation: The device is described as an external ring fixation system intended for fracture fixation, limb lengthening, and correction of deformities. This is a therapeutic and reconstructive device, not a diagnostic one.
No
The device description clearly outlines a system comprised of physical components like wires, screws, rings, rods, and other hardware, made from materials like titanium, stainless steel, and carbon fiber. This is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures involving bone fixation, lengthening, and correction of deformities. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details an external ring fixation system with physical components like wires, screws, rings, and rods. This is a mechanical device used to support and manipulate bone.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on MR compatibility and mechanical engineering analysis, which are relevant to a surgical implant/external fixation device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Product codes
KTT
Device Description
The Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications is an external ring fixation system. The system is comprised of wires and Schanz screws that are attached to rings with bolts, nuts and/or clamps; rods that interconnect the rings; and connecting plates, hinges, standoffs, posts, supports and distractors that complete the assembly of the fixator. This system is a versatile system that is fully customizable. An individualized frame should be constructed for each case to suit the specific situation. The materials of construction for this system include implant grade titanium, elgiloy, stainless steel and carbon fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
Indicated Patient Age Range
adult and pediatric patients
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)
MR testing was performed in accordance with current ASTM Standards, F-2503, F-2052, F-2213 and F-2182 for marking and standard test methods for displacement force, torque and RF heating, IEC 60601-2-33 for safety in a Magnetic Resonance Environment and Guidance for Industry and FDA Staff, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment". Engineering performance evaluation and analysis was performed comparing the proposed devices to the predicate devices and an Engineering analysis was performed and documentation provided to support addition of pediatric indications. The results support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Distraction Osteogenesis System, Synthes Large External Fixation, MR Conditional
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
3.0 510(k) Summary
:
Page __________ of __1
.
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380 Phone: (610) 719-5000
| MAY 11 2010 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Jill R. Yelton, Regulatory Compliance Manager | |
| Device Name: | Synthes Distraction Osteogenesis System, MR Conditional with Expanded
Indications | |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone fixation
appliances and accessories. | |
| Predicate Devices: | Synthes Distraction Osteogenesis System
Synthes Large External Fixation, MR Conditional | |
| Device
Description: | The Synthes Distraction Osteogenesis System, MR Conditional with
Expanded Indications is an external ring fixation system. The system is
comprised of wires and Schanz screws that are attached to rings with bolts,
nuts and/or clamps; rods that interconnect the rings; and connecting plates,
hinges, standoffs, posts, supports and distractors that complete the assembly of
the fixator. This system is a versatile system that is fully customizable. An
individualized frame should be constructed for each case to suit the specific
situation. The materials of construction for this system include implant grade
titanium, elgiloy, stainless steel and carbon fiber. | |
| Intended Use: | The Synthes Distraction Osteogenesis System, MR Conditional is intended for
fracture fixation (open and closed), pseudoarthrosis or non-unions of long
bones, limb lengthening by epiphyseal or metaphyseal distraction, correction
of bony or soft tissue deformities and correction of segmental bony or soft
tissue defects in adult and pediatric patients. | |
| Substantial
Equivalence | Information presented supports the substantial equivalence of the Synthes
Distraction Osteogenesis System, MR Conditional with Expanded Indications
to the predicate devices. The proposed devices have the same indications for
use with addition of MR Conditional and Pediatric, are similar in design,
incorporate the same fundamental product technology and are composed of
the same materials. MR testing was performed in accordance with current
ASTM Standards, F-2503, F-2052, F-2213 and F-2182 for marking and
standard test methods for displacement force, torque and RF heating, IEC
60601-2-33 for safety in a Magnetic Resonance Environment and Guidance for
Industry and FDA Staff, "Establishing Safety and Compatibility of Passive
Implants in the Magnetic Resonance (MR) Environment". Engineering
performance evaluation and analysis was performed comparing the proposed
devices to the predicate devices and an Engineering analysis was performed
and documentation provided to support addition of pediatric indications. The
results support substantial equivalence. | |
, t
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Jill Yelton 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAY 1 1 2010
Re: K092190
Trade/Device Name: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications 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 16, 2010 Received: April 19, 2010
Dear Ms. Yelton:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Ms. Jill Yelton
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 vours.
sincerely yours,
Raubare Briebup
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
KOG 21900 (pg 141) -----------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications
Indications for Use:
The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Orita for nxm
ISION SER Division of Surgical Orthopedic. and Restorative Devices
510(k) Number K092190