(96 days)
Synthes 4.5 mm Curved Broad LCP Plates, Synthes Locking Condylar Plates, Synthes Condylar Buttress Plate - DCP, Synthes 4.5 mm Broad DCP Plates
None
No
The device description and intended use focus on mechanical components (plates and screws) for fracture fixation. There is no mention of AI, ML, image processing, or data-driven analysis.
No
The device is a system of plates and screws used for fracture fixation, which is a structural support device rather than one that treats a disease or condition for therapeutic purposes.
No
The device, the Synthes 4.5 mm VA-LCP Curved Condylar System, is described as consisting of plates and screws used for fracture fixation in the distal femur. Its intended use is to buttress fractures, which is a treatment or repair function, not a diagnostic one.
No
The device description explicitly states it consists of "plates and screws," which are physical 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 states the device is for buttressing multi-fragmentary distal femur fractures. This is a surgical procedure involving the fixation of bone fractures.
- Device Description: The device is described as consisting of plates and screws used for fracture fixation. These are physical implants used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
The Synthes 4.5 mm VA-LCP Curved Condylar System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in hormal or osteopenic bone, and non-unions and malunions.
Product codes
HRS, JDP, HWC
Device Description
The Synthes 4.5 mm VA-LCP Curved Condylar System consists of plates and screws that offer a screw to plate variable angle locking construt. The 4.5 mm VA-LCP Curved Condylar System enhances fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes 4.5 mm Curved Broad LCP Plates, Synthes Locking Condylar Plates, Synthes Condylar Buttress Plate - DCP, Synthes 4.5 mm Broad DCP Plates
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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a stylized font. To the left of the word is a circular logo with a design inside. A registered trademark symbol is present to the right of the word.
一
| 3.0 | 510(k) Summary | K083025 | Page 1 of 1 |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6940 | |||
| Contact: | Sheri L. Musgnung | ||
| Synthes (USA) | |||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6940 | |||
| FAX (610) 484-356-9682 | JAN 14.2009 | ||
| Device Name: | Synthes 4.5 mm VA-LCP Curved Condylar System | ||
| Classification; | Class II, §888.3030 - Single/multiple component metallic bone | ||
| fixation appliances and accessories | |||
| Predicate Device: | Synthes 4.5 mm Curved Broad LCP Plates | ||
| Synthes Locking Condylar Plates | |||
| Synthes Condylar Buttress Plate - DCP | |||
| Synthes 4.5 mm Broad DCP Plates | |||
| Device Description: | The Synthes 4.5 mm VA-LCP Curved Condylar System consists of | ||
| plates and screws that offer a screw to plate variable angle locking | |||
| construt. The 4.5 mm VA-LCP Curved Condylar System enhances | |||
| fracture fixation by providing the flexibility to lock screws in | |||
| trajectories that can diverge from the central axis of the plate hole. | |||
| Intended Use: | The Synthes 4.5 mm VA-LCP Curved Condylar System is intended | ||
| for buttressing multi-fragmentary distal femur fractures including: | |||
| supracondylar, intra-articular and extra-articular condylar fractures, | |||
| periprosthetic fractures, fractures in normal or osteopenic bone, | |||
| and non-unions and malunions. | |||
| Substantial | |||
| Equivalence: | Information presented supports substantial equivalence. |
- September 19.
.
000005
:
..............................................................................................................................................................................
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
· JAN 1 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes® (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester. Pennsylvania 19380
Re: K083025
Trade/Device Name: Synthes® 4.5mm VA-LCP Curved Condylar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II
Product Code: HRS, JDP, HWC Dated: December 10, 2008 Received: December 11, 2008
Dear Ms. Musgnung:
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 (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); 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.
2
Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SYNTHES"
Indications for Use
5 HD(k) Number (if known):
Device Name:
2.0
Synthes 4.5 mm VA-LCP Carved Condylar System
Indications for Use:
The Synthes 4.5 mm VA-1.CP Curved Condyler System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in hormal or osteopenic bone, and non-unions and malunions.
Preseription Use (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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_
ﺖ
000004