(90 days)
Not Found
Not Found
No
The description details a mechanical plate and screw system for fracture fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as a "buttress plate and screw system" intended for "fixation of fractures" and "non-unions and malunions," which are uses consistent with therapeutic intervention to stabilize and heal bone.
No
Explanation: The device is described as a "buttress plate and screw system" intended for the "fixation of osteopenic bone and fixation of non-unions and malunions." This clearly indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly describes a physical plate and screw system, which are hardware components, not software.
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 surgical implant used to fix bone fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a plate and screw system for bone fixation, which is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
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
Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus, medial tibial plateau, distal tibia
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)
Not Found
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.
Synthes T Plates
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
KD10766
3. 510(k) Summary:
:
、
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Bonnie Smith |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA)
Large Fragment Locking Compression Plate (LCP) System - T Plate |
| Device Classification: | 21 CFR 888.3030: "Single/multiple component metallic bone
fixation appliance and accessories" and 888.3040: "Smooth or
threaded metallic bone fixation fastener". |
| Predicate Device: | Synthes T Plates |
| Description of Device: | Synthes Locking Compression Plate (LCP) System - T Plate is a
buttress plate and screw system. The primary feature of the plate is
round holes combined with locking screw holes. The locking
screws form a locked, fixed angle construct with the plate, while the
standard screws facilitate reduction and create compression between
the plate and bone. |
| | The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm
cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0
mm locking screws |
| Indications: | Intended to buttress metaphyseal fractures of the proximal humerus,
medial tibial plateau and distal tibia. Also for use in fixation of
osteopenic bone and fixation of non-unions and malunions. |
| Material: | 316L Stainless Steel
Titanium |
Premarket Notification 510(k) Synthes (USA) Large Fragment LCP System - T Plate CONFIDENTIAL
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000005
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Image /page/1/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
JUN 1 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K010766
Trade Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate
Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: March 13, 2001 Received: March 14, 2001
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Ms. Bonnie J. Smith
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Bmutheuerston
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
2. Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:
Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate
Indications for Use:
Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use U (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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Premarket Notification 510(k) estorative Synthes (USA) Large Fragment LCP Sy CONFIDENTIAL
00004
510(k) Number K010766