(75 days)
Not Found
No
The summary describes a traditional mechanical fixation system (plates and screws) and makes no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is a distal radius fracture fixation plate system, which is an implant used for internal fixation of fractures and osteotomies. It is a surgical implant designed to provide mechanical support rather than a device that delivers therapy or treatment through biological or chemical means.
No
The device description states it is a "distal radius fracture fixation plate system," indicating it is used for internal fixation (treatment) rather than diagnosis.
No
The device description explicitly mentions physical components like "various size plates, right, left, small, large, accessories and instruments" and "bone screws," indicating it is a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of fractures and osteotomies of the distal radius." This describes a surgical procedure to stabilize bone, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The device is a "distal radius fracture fixation plate system" consisting of plates, screws, accessories, and instruments. These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, .
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Product codes (comma separated list FDA assigned to the subject device)
87HRS, HWC
Device Description
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
Orthomet K943853, Synthes K953644
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
Jul 2 9 1998
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
May 13, 1998 Prepared:
Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121
619-452-8580 Telephone: Fax: 619-452-9945 Louise M. Focht Contact:
Device Name:
Device Trade Name:
Device Classification: Reviewing Panel: Regulation Number Product Code: Accessories Predicate Device:
Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Distal Radius Fracture Fixation Plate System Class II Orthopaedic 888.3030 87HRS
Orthomet K943853 Synthes K953644
Device Description:
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Intended Use:
1
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, .
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Comparison to Predicate Device:
The table below summarizes similarities and differences between the Orthomet and the Avanta Orthopaedics plates.
| Feature | Orthomet | Synthes | Avanta Orthopaedics |
|---|---|---|---|
| Plates | Implantable | Implantable | Implantable |
| Screws | Implantable | Implantable | Implantable |
| Material | 316L | 316L | 316L |
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 2 9 1998
Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369 Carroll Park Drive, Suite A San Diego, California 92121
Re: K981715 Distal Radius Fracture Fixation Plate System Requlatory Class: II Product Codes: HWC and HRS Dated: May 13, 1998 Received: May 15, 1998
Dear Ms. Focht:
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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under-Section ----513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
-
- The package insert must prominently state that the device is intended for the specific use(s) described in the enclosure only; and
3
Page 2 - Ms. Louise M. Focht
You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Druq Administration (FDA) prior to conduct of the investigation.
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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
4
Page 3 - Ms. Louise M. Focht
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.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K981715
Distal Radius Fracture Fixation Plate Device Name:
Intended Use:
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, .
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Prescription Use
(Per 21 CFR 801.109)
bòella