(88 days)
No
The 510(k) summary describes a mechanical fixation system (screws and washers) for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are biomechanical tests, not studies of algorithmic performance.
Yes
The device is intended to stabilize the spine as an aid to fusion and is indicated for the surgical treatment of various spinal conditions, directly addressing a medical problem.
No
Explanation: The device is a facet screw fixation system intended to stabilize the spine as an aid to fusion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of screws and washers, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to stabilize the spine to aid in fusion. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as screws and washers, which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability
Product codes
MRW
Device Description
The Discovery Facet Screw Fixation System consists of screws and washers designed to compress bone grafts and/or fractures. The screws are intended only for use in combination with the washer. The system includes two screw styles: fully threaded and lag.
The DISCOVERY Facet Screw is a broad-headed screw that is designed to compact or stabilize adjacent facet articular processes to enhance spinal fusion and stability. The system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1 to S1 (inclusive) spinal levels
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
Biomechanical testing, including static and fatigue 3-Point Bend Testing and Cantilever Testing, were conducted.
Key Metrics
Not Found
Predicate Device(s)
Townley Transfacetpedicular Screw System (K003928), Townley Transfacet/Intrapedicular Screw (K994308)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
| VIII. | 510(k) Summary | ||
|---|---|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc. | ||
| 325 Paramount Drive | |||
| Raynham, MA 02780 | NOV 1 6 2001 | ||
| K012773 | |||
| NOV 1 6 2001 | CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | August 17, 2001 | ||
| CLASSIFICATION NAME: | System, Facet Screw Spinal Device | ||
| PROPRIETARY NAME: | DISCOVERY Facet Screw | ||
| PREDICATE DEVICES: | Preamendment Townley Bone Graft Screw | ||
| Townley Transfacetpedicular Screw System (K003928) | |||
| Townley Transfacet/Intrapedicular Screw (K994308) | |||
| INTENDED USE: | The Discovery Facet Screw Fixation System is intended to | ||
| stabilize the spine as an aid to fusion by two different | |||
| fixation methods: | |||
| Transfacet fixation - The screws are inserted bilaterally | |||
| through the superior side of the facet, across the facet joint | |||
| and into the inferior pedicle. | |||
| Translaminar-facet fixation - The screws are inserted | |||
| bilaterally through the lateral aspect of the spinous process, | |||
| through the lamina, through the superior side of the facet, | |||
| across the facet joint and into the inferior pedicle. | |||
| For both methods, this system is indicated for the posterior | |||
| surgical treatment of any or all of the following at the L1 to | |||
| S1 (inclusive) spinal levels: 1) Trauma, including spinal | |||
| fractures and/or dislocations; 2) Spondylolisthesis; 3) | |||
| Spondylolysis; 4) Pseudoarthrosis or failed previous fusions | |||
| which are symptomatic or which may cause secondary | |||
| instability or deformity; 5) Degenerative diseases which | |||
| include: (a) degenerative disc disease (ddd) as defined by | |||
| neck and/or back pain of discogenic origin as confirmed by | |||
| patient history with degeneration of the disc as confirmed | |||
| by radiographic studies and/or (b) degenerative disease of | |||
| the facets with instability | |||
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium | ||
| alloy. |
.
$P^{1/2}$
:
1
The Discovery Facet Screw Fixation System consists of DESCRIPTION: screws and washers designed to compress bone grafts and/or fractures. The screws are intended only for use in combination with the washer. The system includes two screw styles: fully threaded and lag.
The DISCOVERY Facet Screw is a broad-headed screw that is designed to compact or stabilize adjacent facet articular processes to enhance spinal fusion and stability. The system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
Biomechanical testing, including static and fatigue 3-Point PERFORMANCE DATA: Bend Testing and Cantilever Testing, were conducted.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
NOV 1 6 2001
Re: K012773 Trade/Device Name: Discovery Facet Screw Fixation System Regulatory Number: N/A Regulation Name: N/A Regulatory Class: unclassified Product Code: MR W Dated: August 17, 2001 Received: August 20, 2001
Dear Mr. Maas:
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.
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a
3
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 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Q. Mark N. Millman
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
4
IV. Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
NOV 1 6 2001
DISCOVERY Facet Screw Fixation System Device Name:
Indications For Use:
The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X OR Over-The-Counter Use:
(Per 21 CFR 801.109)
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K012773