(195 days)
,
Not Found
No
The summary describes a mechanical device for securing a graft and does not mention any AI/ML terms or functionalities.
Yes
The device is intended for fixing a bone graft during ACL reconstruction, which is a surgical procedure to repair a damaged ligament, thus serving a therapeutic purpose.
No
The device is described as an ACL Fixator, intended to secure a bone-Patellar Tendon-bone graft during ACL reconstruction. Its function is to provide a means of securing a graft, not to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states the device is made from Titanium alloy, indicating it is a physical hardware device.
Based on the provided information, the QuestLock ACL Fixator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to secure a bone-Patellar Tendon-bone graft during ACL reconstruction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a physical implant made of titanium alloy, designed to be placed within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests in vitro (outside the living body)
The QuestLock ACL Fixator is a surgical implant used to facilitate a surgical repair, not a device used for diagnosis or testing of samples.
N/A
Intended Use / Indications for Use
The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL).
Product codes
Not Found
Device Description
The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL). The fixator is made from Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The QuestLock ACL Fixator demonstrates acceptable pull out strengths.
Key Metrics
Not Found
Predicate Device(s)
The Linvatec Corporation Concept Cannulated Interference Screw, Mitek Ligament Anchor
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a close-up of a handwritten alphanumeric string. The string is "K954683" and is written in a bold, rounded font. The numbers are clearly legible, and the letter 'K' is distinct from the numbers.
Image /page/0/Picture/1 description: The image shows a logo with a stylized letter "W" on the left and a more traditional letter "W" on the right. Below the right "W" is the word "MEDICAL" in a smaller font. Underneath "MEDICAL" are the numbers "5 6 7 7" stacked above the letters "A R L I".
APR 2 3 1996
Contact Person: Date:
Cliff Kline October 6, 1995
510(k) SUMMARY
| Trade/Proprietary Name: | QuestLock ACL Fixator |
|---|---|
| Common Name: | Staple, fixation, bone device |
| Classification: | Class II |
| Predicate Devices: | The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor |
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
The QuestLock ACL Fixator is intended to provide a means for firmly securing a bone-Patellar Tendon-bone graft during reconstruction of an Anterior Cruciate Ligament (ACL). The fixator is made from Titanium alloy.
Substantial Equivalence
The QuestLock ACL Fixator is substantially equivalent to the The Linvatec Corporation Concept Cannulated Interference Screw and the Mitek Ligament Anchor.
Testing
The QuestLock ACL Fixator demonstrates acceptable pull out strengths.