(65 days)
Not Found
No
The device description focuses on mechanical components and their configurations, with no mention of AI, ML, or related concepts.
Yes
This device is intended for the fixation of fractures and osteotomies (surgical cutting of bone) in the femur, which are medical treatments for conditions affecting bone integrity. Therefore, it serves a therapeutic purpose.
No
The device is described as a surgical implant for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly details physical components like plates, blades, and screws, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Synthes Modular Blade Plate System is a surgical implant used to fix bone fractures. It is physically implanted into the body to stabilize bones.
- Intended Use: The intended use is for "fixation of fractures and osteotomies of the proximal and distal femur." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a device used in vivo (within the body) for structural support, not a device used in vitro (in glass, or outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Product codes
KTW
Device Description
The Synthes (USA) Modular Blade Plate System is comprised of a spiral blade that attaches to one end of a side plate, secured with a coupling screw to create a fixed angle construct. The Modular Plates are available in various configurations - 90°, 110°, 120° and 130° plates with off-sets, and 95° or 130° plates without off-sets. The Modular Plates have standard locking-compression holes (LCP) in the shaft and are available in a variety of lengths to accommodate varying injury, patient anatomy and size. The Modular Plates are available to be used with 4.5 mm Cortex screws or 5.0 mm Locking screws. The Spiral Blades rotate 90° clockwise or counterclockwise over the length of the blade. A variety of lengths are available to accommodate varying patient anatomy. The coupling screw is one size fits all plate and blade configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal and distal femur
Indicated Patient Age Range
adolescents and adults
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Angled Blade Plates (Pre-amendment and K914546)
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
K080109 (pg 1/1)
MAR 2 0 2008
3.0 510(k) Summary
Page 1 - 1 of
Sponsor:
Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-5000
Contact:
Jill R. Sherman Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 610-719-6538
Device Name: Synthes (USA) Modular Blade Plate System
Classification:
21 CFR Part 888.3030; Single/multiple component metallic bone fixation appliances and accessories.
Synthes Angled Blade Plates (Pre-amendment and K914546) Predicate Device:
Device Description: The Synthes (USA) Modular Blade Plate System is comprised of a spiral blade that attaches to one end of a side plate, secured with a coupling screw to create a fixed angle construct. The Modular Plates are available in various configurations - 90°, 110°, 120° and 130° plates with off-sets, and 95° or 130° plates without off-sets. The Modular Plates have standard locking-compression holes (LCP) in the shaft and are available in a variety of lengths to accommodate varying injury, patient anatomy and size. The Modular Plates are available to be used with 4.5 mm Cortex screws or 5.0 mm Locking screws. The Spiral Blades rotate 90° clockwise or counterclockwise over the length of the blade. A variety of lengths are available to accommodate varying patient anatomy. The coupling screw is one size fits all plate and blade configurations.
Intended Use:
The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Substantial Equivalence: Information presented supports substantial equivalence,
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Jill R. Sherman 1301 Goshen Parkway West Chester, PA 19380
MAR 2 0 2008
Re: K080109 Trade/Device Name: Synthes (USA) Modular Blade Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTW Dated: January 11, 2008 Received: January 15, 2008
Dear Ms. Sherman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Jill R. Sherman
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 vours.
Mark N. Milliken
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K080109 (pg 1/1)
Image /page/3/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small registered trademark symbol is located to the right of the word.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes (USA) Modular Blade Plate System
The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Prescription Use X (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)
Oputa
(Division Sign-Off)
ರ Division of General, Restorative, and Neurological Devices
510(k) Number K080109