(106 days)
Not Found
No
The summary describes a system of plates and instruments for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device, the 2.7mm LCP Ulna Osteotomy System, is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. While it assists in the healing process, its primary function is mechanical support and stabilization, which falls under surgical or orthopedic fixation rather than direct therapeutic action.
No
The device is a system for fracture fixation and osteotomy, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it consists of physical components (plates, instrumentation) made of titanium alloy and stainless steel, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system for fixing fractures, osteotomies, nonunions, replantations, and fusions of bones in the ulna. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device consists of plates and instrumentation for surgical procedures. This aligns with a surgical implant and tool system, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies mentioned are bench testing related to mechanical strength and bending, which are relevant to surgical implants, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Product codes
HRS, HWC
Device Description
The 2.7mm LCP Ulna Osteotomy System consists of two plates, 6-hole and 8-hole which will be available in titanium alloy and stainless steel, to be offered sterile and non-sterile. This system also includes instrumentation which supports transverse and oblique osteotomy cuts as well as plate placement and fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna, small bones and small bone fragments
Indicated Patient Age Range
adults and adolescents (12-21 years)
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)
static and dynamic bench testing was performed as well as calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and material characteristics, defined in standard
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KII3364
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ース
FEB 2 9 2012
510(k) Summary
・
| Sponsor: | Synthes (USA)
Rebecca Blank
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-1268 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | 2.7mm LCP Ulna Osteotomy System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone
fixation appliances and accessories, HRS |
| | Class II, §888.3040 - Smooth or threaded metallic bone fixation
fastener, HWC |
| Predicate Device: | K063049- Modular Mini Fragment LCP System
K001941- Synthes Modular Foot System (not in comparison table)
K073228 - DC Ulnar Shortening System |
| Device Description: | The 2.7mm LCP Ulna Osteotomy System consists of two plates, 6-
hole and 8-hole which will be available in titanium alloy and
stainless steel, to be offered sterile and non-sterile. This system also
includes instrumentation which supports transverse and oblique
osteotomy cuts as well as plate placement and fixation. |
| Intended Use: | The 2.7mm LCP Ulna Osteotomy System is indicated for fixation
of fractures, osteotomies, nonunions, replantations, and fusions of
small bones and small bone fragments, including osteopenic bone
in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated
for use in both adults and adolescents (12-21 years) in which
growth plates have fused or in which growth plates will not be
crossed by screw fixation. |
| Substantial
Equivalence: | Information presented supports substantial equivalence of the
Synthes 2.7mm LCP Ulna Osteotomy System to predicate devices.
The proposed system has the same indications for use, is similar in
design, incorporates the same fundamental product technology and
is composed of the same materials. |
| | To additionally support substantial equivalence, static and dynamic
bench testing was performed as well as calculations comparing the
bending strength of the subject and predicate devices based on
geometric analyses and material characteristics, defined in standard |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Ms. Rebecca Blank 1301 Goshen Parkway West Chester, Pennsylvania 19380
FEB 2 9 2012
Re: K113364 Trade/Device Name: 2.7 LCP Ulna Osteotomy System 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: February 7, 2012 Received: February 12, 2012
Dear Ms. Blank:
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
2
Page 2 – Ms. Rebecca Blank
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. Molkersen
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
510(k) Number (if known): K113364
Device Name: Synthes (USA) 2.7mm LCP Ulna Osteotomy System
Indications for Use:
The 2.7mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
AND/OR Prescription Use X _ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII3364 510(k) Number.