(72 days)
Not Found
No
The description focuses on the mechanical properties and design of bone plates and screws for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is intended for the fixation of fractures, osteotomies, malunions, and non-unions of bones in adults and adolescents, which aligns with the definition of a therapeutic device as it treats a medical condition.
No
The device is described as an implantable system (plates and screws) for fixation of fractures, malunions, and non-unions of bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it contains "plates intended to treat fractures" and describes various physical plate types made of stainless steel and titanium. This indicates a hardware-based medical device, not a software-only one.
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 the "fixation of fractures of the distal humerus, olecranon and ulna". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a system of plates and screws used to stabilize bones. This is a physical implant used in surgery.
- 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 about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the Synthes Variable Angle LCP Elbow System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
- Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
Product codes
HRS, HWC
Device Description
The Synthes Variable Angle LCP Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system:
• Medial Distal Humerus Plate
• Lateral Distal Humerus Plate
• Olecranon Plate
• Proximal Olecranon Plate
• Extra-articular Proximal Ulna Plate
The system accepts existing cortical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus, olecranon, ulna
Indicated Patient Age Range
adults and adolescents (12-21) in which the growth plates have fused.
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
Static and fatigue strength testing, as well as engineering strength analyses, were completed for the plates included in the Synthes Variable Angle LCP Elbow System, demonstrating equal to or greater strength in comparison to the predicate devices and constructs
Key Metrics
Not Found
Predicate Device(s)
K033995, K000684, K011335, K100776
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
MAR 2 1 2012
510(k) Summary
Date Prepared: March 19, 2012
| Sponsor: | Synthes
Angela F. Lassandro.
1301 Goshen Parkway
West Chester, PA19380
(610) 719-6854 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Variable Angle LCP Elbow System |
| Classification: | Classification:Class II, §888.3030, Single/multiple component metallic bone
fixation appliances and accessories. |
| Predicate Device: | Product Code: HRS, HWC
Synthes 3.5mm LCP Elbow System (K033995)
Synthes Small Fragment System (K000684, K011335)
Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot /Midfoot System (K100776) |
| Device
Description: | The Synthes Variable Angle LCP Elbow System contains plates intended to treat
fractures of the distal humerus and proximal ulna. A variety of plate
configurations are included in the system to allow for fixation of multiple
fracture patterns. Specifically, the system includes several plate configurations
for fixation of the distal humerus which are intended to be used in a two-plate
construct where plates are positioned medially and laterally. Additionally, the
system includes plates for fixation of the olecranon and proximal ulna. In its
entirety, the following plate types are included in the system:
• Medial Distal Humerus Plate
• Lateral Distal Humerus Plate
• Olecranon Plate
• Proximal Olecranon Plate
• Extra-articular Proximal Ulna Plate
The system accepts existing cortical and locking screws as well as new
metaphyseal screws, and allows for both dynamic compression and locking
through Combi holes. The plates are universally designed for both left and right
use and will be offered in both stainless steel and titanium. |
| Intended Use: | The Synthes Variable Angle LCP Elbow System is intended for fixation of
fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-
21) in which the growth plates have fused. Specifically,
• Distal humerus plates are indicated for intra-articular fractures,
comminuted supracondylar fractures, osteotomies, malunions and
non-unions of the distal humerus.
• Olecranon and Proximal ulna plates are indicated for fractures,
osteotomies, malunions and non-unions of the olecranon and proximal
ulna. |
| Substantial
Equivalence: | Both the subject Synthes VA Elbow System and predicate Synthes3.5mm LCP
Elbow System and Small Fragment System have similar indications, design
characteristics, materials, and performance characteristics. Static and fatigue
strength testing, as well as engineering strength analyses, were completed for the
plates included in the Synthes Variable Angle LCP Elbow System,
demonstrating equal to or greater strength in comparison to the predicate devices
and constructs |
Page
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The words are in a dark color, likely black or a dark shade of gray, against a light background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 1 2012
Synthes · % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K120070
Trade/Device Name: Synthes Variable Angle LCP Elbow System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS, HWC Dated: January 6, 2012 Received: January 10, 2012
Dear Ms. Lassandro:
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
2
Page 2 - Ms. Angela F. Lassandro
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 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/ucm115809.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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 Statement
510(k) Number (if known):
/20070
Device Name:
Synthes Variable Angle LCP Elbow System
Indications for Use:
The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
- · Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- · Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
X Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Dirision Sien-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120070