(102 days)
None
Not Found
No
The summary describes a simple bone filler material and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a bone filler that resorbs and is replaced with bone during the healing process, indicating it is used for treatment and healing of osseous defects.
No
The device, Wright Plaster of Paris Pellets, is explicitly described as a bone filler intended to resorb and be replaced by bone during healing, and its function is to fill bone voids, not to diagnose medical conditions.
No
The device is described as physical pellets made of Plaster of Paris, intended to be packed into bone voids. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "gently packed into non-loadbearing long bone voids" to provide a bone filler. This is a therapeutic and structural application within the body.
- Device Description: The description details a physical implantable material (pellets) that is resorbed by the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the healing process.
Product codes
Unclassified
Device Description
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in 30 to 60 days when used according to labeling. Wright Plaster of Paris Pellets are 0.1g each and are supplied in pouches of 100 pellets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-loadbearing long bone voids
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
Dissolution studies demonstrate Wright Plaster of Paris Pellets to possess equivalent dissolution rates to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Plaster of Paris Pellets (Ethicon)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
JUN 21 1996
Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol on the left, followed by the word "WRIGHT" in bold, uppercase letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." Underneath that is the address "5677 AIRLINE ROAD ARLINGTON, TN 3800" and the phone number "901-867-9971".
Contact Person: Robert Churinetz Date Prepared: June 6, 1996
510(k) Summary of Safety and Efficacy
| Trade/Proprietary Name: | Wright Plaster of Paris Pellets |
|---|---|
| Common Name: | Calcium Sulfate Dihydrate |
| Product Classification: | Unclassified |
| Predicate Devices: | Plaster of Paris Pellets (Ethicon) |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
Wright Plaster of Paris Pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in 30 to 60 days when used according to labeling. Wright Plaster of Paris Pellets are 0.1g each and are supplied in pouches of 100 pellets.
Wright Plaster of Paris Pellets are intended to be gently packed into non-loadbearing long bone voids. These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Wright Plaster of Paris Pellets provide a bone filler that resorbs and is replaced with bone during the healing process.
Material
Wright Plaster of Paris Pellets are made of 98% medical grade calcium dihydrate (CaSO4 . 2H20) and 2% stearic acid.
Testing Summarv
Dissolution studies demonstrate Wright Plaster of Paris Pellets to possess equivalent dissolution rates to the predicate device.