(50 days)
No
The summary describes a mechanical orthopedic plate and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a plate intended for treating fractures and osteotomies of the calcaneus, which directly addresses a medical condition.
No
Explanation: This device, the Synthes Locking Calcaneal Plate, is described as a plate for treating fractures and osteotomies of the calcaneus, indicating it is an orthopedic implant used for surgical intervention rather than for diagnosing medical conditions.
No
The device description clearly describes a physical plate made of metal with screw holes, indicating it is a hardware device, not software.
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, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Synthes Locking Calcaneal Plates are implants used to fix fractures and osteotomies of the calcaneus (heel bone). They are applied surgically to the bone.
- Intended Use: The intended use is to treat bone fractures and osteotomies, which is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
Product codes
LXT
Device Description
Synthes LCPs are designed to address complex fractures of the calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes Multiple Fragment Plate (preamendment), K981372
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.
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Image /page/0/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 image of a person. To the right of the word is a small circle with an R inside, indicating that the word is a registered trademark.
JUN 1 1 1999
Attachment VI:
SUBMITTER
Summary of Safety and Effectiveness Information [510(k) Summary]
- Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
Synthes Locking Calcaneal Plates
DEVICE NAME:
COMMON OR USUAL NAME
DEVICE CLASSIFICATION:
N.
Plate, fixation, bone
Class II, 21 CFR 888.3030
Synthes Multiple Fragment Plate (preamendment) PREDICATE DEVICE: Synthes 3.0 mm PC-Fix™ System, (K981372).
Synthes LCPs are designed to address complex fractures of the DESCRIPTION: calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.
For fractures and osteotomies of the calcaneus, including, but INTENDED USE: not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
- 316L Stainless Steel, Ti-15Mo MATERIAL:
Synthes (USA) Locking Calcaneal Plates CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or birds in flight, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1999
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
K991407 Re : Synthes (USA) Locking Calcaneal Plates Trade Name: Regulatory Class: II Product Code: LXT Dated: April 21, 1999 Received: April 22, 1999
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sheri L. Musqnung
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten. Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices.and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small "R" in a circle is located to the right of the word, indicating a registered trademark. The logo and text are the only elements in the image.
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510(k) Number (if known):
Synthes Locking Calcaneal Plates Device Name:
Indications For Use:
Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extraarticular, intra-articular, joint depression, tongue type and severely comminuted fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
PCorella
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices (مربع 0 رد 4 0 ر م ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 510(k) Number _
Synthes (USA) Locking Calcaneal Plates CONFIDENTIAL
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