(35 days)
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Ankle Trauma System" intended for "fixation of the ankle" and "fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments", which are medical conditions or injuries. Therefore, it is a therapeutic device.
No
The device description indicates it is a system of plates and screws intended for fixation of the ankle after fractures or osteotomies. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a system of plates and screws made of stainless steel and titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a system of plates and screws intended for the surgical fixation of bones in the ankle. This is an implantable medical device used directly on the patient's anatomy.
- Intended Use: The intended use clearly states the device is for "fixation of the ankle in adults and adolescents" and for treating "osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments." This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
Therefore, based on the provided information, the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle and is indicated in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,
• Anterolateral 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.
• 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 Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws.
The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations.
The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking 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 devices through engineering analysis and fatigue strength testing. Similarly, the new screws have been shown to be substantially equivalent to existing screws through analysis and dimensional comparison to the predicate 3.5mm Cortex Screws (K112583) and 3.5mm Locking Screws (K000684).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120854, K033805, K040593, K042598, K043227, K043560, K030121, K051098, K112583, K000684
Reference Device(s)
K100776, K063049, K111230, K120070, K110592, K043185
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
KIZI 601
6 2012 JUL
510(k) Summary
Date Prepared: June 22, 2012
| Sponsor: | Synthes
Angela F. Lassandro
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6854 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral
Distal Tibia Plates |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bone
fixation appliances and accessories.
Product Code: HRS, HWC |
| Predicate Device: | Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K120854)
Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805)
Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227,
K043560, K030121, K051098, and Pre-amendment)
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) |
| Device
Description: | The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of
the distal tibia. These plates can be used with a new screw configuration,
3.5mm VA Locking Screws.
The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be
offered in both stainless steel and titanium alloy (TAN), and in both sterile and
non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered
in left and right configurations.
The system accepts existing cortical screws, locking screws, dynamic locking
screws, and metaphyseal screws (K100776, K063049, K112583, K000684,
K111230, K120070, K110592, and K043185) as well as new 3.5mm VA
Locking Screws, and allows for both dynamic compression and locking through
Combi holes. |
| Intended Use/
Indications for Use | The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended
for fixation of the ankle and is indicated in adults and adolescents (12-21) in
which the growth plates have fused, and particularly in osteopenic bone.
Specifically,
• Anterolateral 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.
• 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 2.7/3.5mm VA-LCP Ankle Trauma System and
predicate Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K120854), Synthes
4.5/3.5 LCP Metaphyseal Plate (K033805) and Zimmer Periarticular and ECT
Plate (K040593, K042598, K043227, K043560, K030121, K051098, and Pre-
amendment) 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 devices through engineering analysis and fatigue
strength testing. Similarly, the new screws have been shown to be substantially
equivalent to existing screws through analysis and dimensional comparison to
the predicate 3.5mm Cortex Screws (K112583) and 3.5mm Locking Screws
(K000684). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.
Public Health Service
JUL
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
6 2012
Synthes % Ms. Angela F. Lassandro Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K121601
Trade/Device Name: Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System -Anterolateral Distal Tibia Plates
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS, HWC Dated: May 30, 2012 Received: June 1, 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
3
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/ReportalProblem/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.
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________
Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System Device Name:
Indications for Use:
The Synthes 2.7/3.5mm 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,
- · Anterolateral 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.
- · 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 _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DÓ NOT WRITE BÈLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ast
(Division Sign-Off) Division o: urgical, Orthopedic, and Restorative Devices
K121601 510(k) Number_