(76 days)
Synthes Straight Wrist Fusion Plate, Biomet® Colles Fracture Plate
Not Found
No
The 510(k) summary describes a purely mechanical implant (a titanium plate) for wrist fusion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a wrist fusion plate intended for plate fixation in wrist arthrodesis, which is a surgical procedure to fuse the bones of the wrist. While it addresses a medical condition, its primary function is structural support and fixation, not therapy in the sense of treatment or rehabilitation.
No
Explanation: The device is a surgical implant (plate) used for fixation in wrist arthrodesis. It does not perform any diagnostic function.
No
The device description clearly describes a physical titanium plate and associated screws, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Synthes Small Titanium Wrist Fusion Plate is a physical implantable device (a plate and screws) used for surgical fixation of the wrist.
- Intended Use: The intended use is for plate fixation during wrist arthrodesis (surgical fusion of the wrist joint) in patients with specific disorders. This is a surgical procedure, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes small titanium wrist fusion plate is a low profile plate with a 2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm. The plate uses a total of 8 holes across the 107 mm pre-contoured length. There are proximal and distal holes which utilizes 2.7 mm and 2.4mm screws. Limited contact undercuts are included to minimize plate to bone contact and the ends are tapered in thickness for minimal soft tissue irritation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
pediatric patient
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 Straight Wrist Fusion Plate, Biomet® Colles Fracture Plate
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
FEB 0 5 2003
.
Summary of Safety and Effectiveness Information - 510(k) Summary 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Small Titanium Wrist Fusion Plate |
| CLASSIFICATION: | Class II, § 888.3030 - Single / multiple component metallic bone fixation
appliance and accessories |
| PREDICATE DEVICE: | Synthes Straight Wrist Fusion PlateBiomet® Colles Fracture Plate |
| DEVICE DESCRIPTION: | The Synthes small titanium wrist fusion plate is a low profile plate with a
2.1 mm thickness, a proximal width of 8mm and a distal width of 6 mm.
The plate uses a total of 8 holes across the 107 mm pre-contoured length.
There are proximal and distal holes which utilizes 2.7 mm and 2.4mm
screws. Limited contact undercuts are included to minimize plate to bone
contact and the ends are tapered in thickness for minimal soft tissue
irritation. |
| INTENDED USE: | The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use
in plate fixation for wrist arthrodesis in patients with disorders such as
cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This
plate addresses the smaller stature and pediatric patient by having a low
profile construct and utilizing small screws. |
| MATERIAL: | CP Titanium |
Confidential
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) P. O. Box 1766 1690 Russell Road Paoli. Pennsylvania 19301
Re: K023879
Trade/Device Name: Synthes Small Titanium Wrist Fusion Plate Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 18, 2002 Received: November 21, 2002
Dear Ms. Boyle:
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
2
Page 2 - Ms. Lisa M. Boyle
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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). Other general information on your responsibilities under the Act may be obtained 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 N Millman
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
2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K023879 |
|---|---|
| Device Name: | Synthes (USA) Small Titanium Wrist Fusion Plate |
Indications/Contraindications:
The Synthes (USA) Small Titanium Wrist Fusion Plate is intended for use in plate fixation for wrist arthrodesis in patients with disorders such as cerebral palsy, brachial plexopathy, spinal cord injuries, and trauma. This plate addresses the smaller stature and pediatric patient by having a low profile construct and utilizing small screws.
(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_
for Mark N Milkeran
(Division Sign-Off)
Confidential