(83 days)
Synthes Small T- Plate, Synthes LCP T-Plate and Howmedica's Bosworth Screw
Not Found
No
The summary describes a mechanical implant (plate and screws) for fracture fixation and joint stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as a plate for fixation of fractures and dislocations, indicating it is an orthopedic implant for structural support, not a device that provides therapy (e.g., drug delivery, physical therapy stimulation).
No
The device is described as an L-shaped plate with a hook, screws, and holes, intended for the fixation of bone fractures and dislocations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical plate and screws, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint." This describes a surgical implant used to physically stabilize bones and joints within the body.
- Device Description: The description details a "plate" with "screw holes" and a "hook," designed to be implanted. This is consistent with a surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for mechanical support.
N/A
Intended Use / Indications for Use
Intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, acromioclavicular joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Small T- Plate, Synthes LCP T-Plate and Howmedica's Bosworth Screw
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 2 1 2003
3. 510(k) Summary:
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bonnie Smith |
| Device Name | Synthes (USA) Clavicle Hook Plate |
| Device Classification | 21 CFR 888.3030 - Single/multiple component metallic bone
fixation appliance and accessories |
| Predicate Device | Synthes Small T- Plate, Synthes LCP T-Plate and Howmedica's
Bosworth Screw |
| Description of Device | Synthes Clavicle Hook Plate is an anatomically designed L-shaped
plate featuring a distal joint bridging hook with a rounded end.
The shaft of the plate contains either dynamic compression screw
holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm
cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate
only). |
| Indications | Intended for fixation of lateral clavicle fractures and dislocations of
the acromioclavicular joint |
| Material | 316L Stainless Steel
Titanium |
| Substantial Equivalence | Documentation is provided which demonstrates that the Synthes
Clavicle Hook Plate is substantially equivalent* to other legally
marketed Synthes devices. |
| | * The term "substantial equivalence" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Food, Drug and Cosmetic Act, as amended and as
applied under 21 CFR 807, Subpart E, under which a device can be
marketed without pre-market approval or reclassification. A
determination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence
herein shall be construed as an admission against interest under the
US Patent Laws or their application by the courts. |
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K031677
Trade/Device Name: Synthes Clavicle Hook Plate Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: May 29, 2003 Received: May 30, 2003
Dear Ms. Smith:
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
2
Page 2 – Ms. Bonnie J. Smith
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.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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melleuson
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
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2. Indications for Use
Page 1 of 1
| 510(k) Number (if known): | K031677 |
|---|---|
| Device Name: | Synthes Clavicle Hook Plate |
| Indications for Use: | Intended for fixation of lateral clavicle fractures and dislocations of |
| the acromioclavicular joint. |
(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
Mark n Millerm
(Division Sign-C I) Division of Gene al, Restorative and Neurological Devices
510(k) Number K031677
CONFIDENTIAL 90004
Premarket Notification 510(k) Synthes (USA) Clavicle Hook Plate