(86 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for fixation of fractures, osteotomies, and non-unions, which are therapeutic interventions.
No
Explanation: The device is described as a "Dynamic Compression Locking Plate System" intended for "fixation of fractures, osteotomies, and non-unions." This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly describes physical plates and screws intended for surgical implantation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures, osteotomies, and non-unions" of various bones. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "threaded version of the currently marketed Synthes Third Tubular Plate" that accepts "locking screws." This describes a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to stabilize bone.
N/A
Intended Use / Indications for Use
Synthes Dynamic Compression Locking Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.
Product codes
HRS
Device Description
Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula
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)
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
JUL 2 7 2001
: .
011335
.
3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes One-Third Tubular DCL Plate |
| Regulation & Classification | Class II, §888.3030 - Plate, Fixation, Bone
(HRS) |
| Predicate Device | Synthes Third Tubular Plate (Pre-Amendment)
Synthes Small Fragment Dynamic Compression Locking (DCL)
System (K000684) |
| Device Description | Synthes One-Third Tubular DCL Plate line extension is a threaded
version of the currently marketed Synthes Third Tubular Plate. The
threaded plates will accept locking screws and therefore can be
included as part of the Small Fragment DCL System. The new plates
have the same intended use as other plates in the system and there is
no change in safety or efficacy. |
| Intended Use | Synthes Dynamic Compression Locking Plate System is intended for
fixation of fractures, osteotomies, and non-unions of the clavicle,
scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and
fibula, particularly in osteopenic bone as a part of the Synthes Small
Fragment DCL System. |
| Technological
Characteristics | The Synthes One-Third Tubular Plate has the same technological
characteristics as the predicate device/ system identified above. Both
will be offered in the same materials and with the same sterility
options. The only difference is that these new plates will have the
locking threads and be offered as a part of the Synthes Small
Fragment DCL System. |
Abbreviated 510(k): Synthes One-Third Tubular Plate for the Small Fragment DCL System (Line Extension) CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
JUL 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K011335
Trade Name: Synthes One-Third Tubular DCL Plate Regulation Number: 21 CFR 888.3030 Regulatory Class: II Product Code: HRS Dated: April 30, 2001 Received: May 2. 2001
Dear Mr. Hull:
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 regulations 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 regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou 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.
2
Page 2 - Mr. Matthew M. Hull, RAC
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Bmtcheetuthor
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
8. Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications/ Contraindications:
KO11335
Synthes One-Third Tubular Plate
Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.
(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_
взткишичкортскии
(Division Sign-Off) (Division Sign of General, Restorative DIVision of Neurological Devices
Abbreviated 510(k): Synthes One-Third Tubular1fdffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffff nt DCL System (Line Extension) CONFIDENTIAL
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