(65 days)
Not Found
No
The device description details a mechanical plate and screw system for fracture fixation, with no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a plate and screw system designed to stabilize fractures, which is a structural implantation for support rather than a device that provides therapeutic treatment.
No
The device is a plate and screw system intended for buttressing fractures, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "plate and screw system," which are physical hardware components used in orthopedic surgery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Synthes LCP System is a "plate and screw system" intended for fixing bone fractures. It is a physical implant used in surgery.
- Intended Use: The intended use is to "buttress multifragmentary distal femur fractures," which is a surgical procedure to stabilize broken bones.
This device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Synthes LCP System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTY, JDW
Device Description
Synthes LCP System is a plate and screw system. The primary feature of the plate and screw system is that the locking screws engage with the head and shaft of the plate to form a locked, fixed angle construct. The system features a limited-contact profile, dynamic compression unit (DCU) and locking screw holes. The plate accepts 7.3 mm locking screws, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mm cannulated screws, and 4.5 mm cortex screws. A screw nut is also utilized with this system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur
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.
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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. A small circle with a dot inside is located to the right of the word.
· Mar 1 5 2000
K00066
| Attachment VI: | Summary of Safety and Effectiveness Information
[510(k) Summary] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
| | Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Locking Condylar Plate (LCP) System |
| COMMON OR USUAL
NAME | Appliance, Fixation, Nail/Blade/Plate Combination, Single
Component;
Screw, Fixation, Bone |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes Distal Femur Plate (DFP) System, (K982222) |
| DESCRIPTION: | Synthes LCP System is a plate and screw system. The primary feature of
the plate and screw system is that the locking screws engage with the
head and shaft of the plate to form a locked, fixed angle construct. The
system features a limited-contact profile, dynamic compression unit
(DCU) and locking screw holes. The plate accepts 7.3 mm locking
screws, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mm
cannulated screws, and 4.5 mm cortex screws. A screw nut is also
utilized with this system. |
| INTENDED USE: | Synthes LCP System is intended for buttressing
multifragmentary distal femur fractures including:
supracondylar, intra-articular and extra-articular condylar
fractures, fractures in normal or osteopenic bone, and non-
unions and malunions. |
| MATERIAL: | Stainless Steel |
Synthes Locking Condylar Plate System 510(k) Synthes (USA)
.
CONFIDENTIAL
:
0000000
1
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K000066
Trade Name: Synthes Locking Condylar Plate (LCP) System Regulatory Class: Class II Product Codes: HRS, HWC, HTY, and JDW Dated: January 7, 2000 Received: January 10, 2000
Dear Ms. Musgnung:
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 requirements, 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.
2
Page 2 -- Ms. Sheri L. Musgnung
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 additionally 009110 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" (21CFR 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Synthes (USA) Locking Condylar Plate (LCP) System Device Name:
Indications For Use:
Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and 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_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
NPO for Faria
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K000066
CONFIDENTIAL