(89 days)
No
The summary describes a system of plates and screws for bone fixation and does not mention any AI or ML components.
Yes
The device is intended for the fixation of bones and bone fragments, addressing conditions like fractures, nonunions, and malunions, which directly contribute to the healing and restoration of function, fitting the definition of a therapeutic device.
No
This device, the Synthes Variable Angle LCP Ankle Trauma System, is an orthopedic implant system intended for fixation of the ankle, specifically for fractures, osteotomies, and other bone issues. It is a treatment device, not a diagnostic one.
No
The device description clearly states it includes physical components such as plates and screws made of stainless steel and titanium alloy, which are hardware.
Based on the provided text, 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 the ankle in adults and adolescents... particularly in osteopenic bone." This describes a surgical implant used to stabilize bones.
- Device Description: The description details plates and screws designed to treat fractures. These are physical implants, not reagents or instruments used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used to treat a physical injury.
N/A
Intended Use / Indications for Use
The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,
- Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia
- Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Product codes
HRS, HWC
Device Description
The Synthes Variable Angle LCP Ankle Trauma System contains plates that are intended to treat fractures of the ankle, and includes multiple plate types to accommodate different fracture patterns and patient anatomy. Two new screw configurations are included in the Synthes Variable Angle LCP Ankle Trauma System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws. Specifically, the following plates and screws are included in the Synthes Variable Angle LCP Ankle Trauma System:
• Medial and Anteromedial Distal Tibia Plates
• Distal Tibia T Plates and Distal Tibia L Plates
• Lateral Distal Fibula plate
• 2.7mm Metaphyseal Screws
• 3.5mm VA Locking Screws
All of the plates will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. All of the plate configurations (with the exception of the Distal Tibia T plate, which is symmetrical), will be offered in left and right designs. The system accepts existing cortical and locking screws (i.e. K000684 and K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal Screws, and allows for both dynamic compression and locking through Combi holes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, distal tibia, distal fibula
Indicated Patient Age Range
adults and adolescents (12-21) in which the growth plates have fused
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)
The subject system has been shown to be at least as strong as the predicate systems through engineering analysis, static strength, and fatigue strength testing. Similarly, the new screws have been shown to be substantially equivalent to existing screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033805, K083213, K073460, K011335, K112583, K000684, K100776, K110354, K120070, K120717
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
K12.0854
JUN 1 8 2012
| 510K Summary | |
|---|---|
| Sponsor: | Synthes |
| Angela F. Lassandro | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6854 | |
| Device Name: | Synthes Variable Angle LCP Ankle Trauma System |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bone |
| fixation appliances and accessories. | |
| Product Code: HRS, HWC | |
| Predicate Device: | Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805) |
| Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460) | |
| Synthes One-Third Tubular Plates (K011335) | |
| 3.5mm Cortex Screws (K112583) | |
| 3.5 mm Locking Screws (K000684) | |
| Synthes 2.7mm VA Locking Screws (K100776) | |
| 4.5mm VA Curved Condylar Plate Set (K110354) | |
| 2.7/3.5mm VA-LCP Elbow System (K120070 and K120717) | |
| Device | |
| Description: | The Synthes Variable Angle LCP Ankle Trauma System contains plates that are |
| intended to treat fractures of the ankle, and includes multiple plate types to | |
| accommodate different fracture patterns and patient anatomy. Two new screw | |
| configurations are included in the Synthes Variable Angle LCP Ankle Trauma | |
| System; 2.7mm metaphyseal screws and 3.5mm VA Locking Screws. | |
| Specifically, the following plates and screws are included in the Synthes | |
| Variable Angle LCP Ankle Trauma System: | |
| • Medial and Anteromedial Distal Tibia Plates | |
| • Distal Tibia T Plates and Distal Tibia L Plates | |
| • Lateral Distal Fibula plate | |
| • 2.7mm Metaphyseal Screws | |
| • 3.5mm VA Locking Screws |
All of the plates will be offered in both stainless steel and titanium alloy (TAN),
and in both sterile and non-sterile configurations. All of the plate configurations
(with the exception of the Distal Tibia T plate, which is symmetrical), will be
offered in left and right designs.
The system accepts existing cortical and locking screws (i.e. K000684 and
K043185) as well as new 3.5mm VA Locking Screws and 2.7mm Metaphyseal
Screws, and allows for both dynamic compression and locking through Combi
holes. |
Page 112
. .
Date Prepared: May 23, 2012
与10k Summary
1
K 120 854
| Intended Use: | The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation
of the ankle in adults and adolescents (12-21) in which the growth plates have
fused, and particularly in osteopenic bone. Specifically, Medial and Anteromedial Distal Tibia Plates are intended for fixation
of osteotomies, fractures, nonunions, malunions, and replantations of
bones and bone fragments of the diaphyseal and metaphyseal regions
of the distal tibia Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress
partial articular fractures and bone fragments of the distal tibia, and Lateral Distal Fibula Plates are intended for fixation of osteotomies,
fractures, nonunions, malunions, and replantations of bones and bone
fragments of the diaphyseal and metaphyseal regions of the distal
fibula. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | Both the subject Synthes VA-LCP Ankle Trauma System and predicate Synthes
Systems have similar indications, design characteristics, materials, and
performance characteristics. The subject system has been shown to be at least as
strong as the predicate systems through engineering analysis, static strength, and
fatigue strength testing. Similarly, the new screws have been shown to be
substantially equivalent to existing screws. |
: : :
.
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Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2012
Synthes % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K120854
Trade/Device Name: Synthes Variable Angle LCP Ankle Trauma System Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: HRS, HWC Dated: May 23, 2012 Received: May 25, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 – Ms. Angela F. Lassandro
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
ho mp
pto Rump Dr
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/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 inside of a circle. The logo is also in black. There is a registered trademark symbol to the right of the word "SYNTHES".
4.0 - Indications for Use Statement
510(k) Number (if known):
120854
Device Name:
Synthes Variable Angle LCP Ankle Trauma System
Indications for Use:
The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,
- · Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- · Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- · Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Prescription 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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K120854