DISCOVERY FACET SCREW FIXATION SYSTEM by DEPUY ACROMED

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

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.

AI/ML Overview

This section describes the acceptance criteria and the study conducted to demonstrate the performance of the DISCOVERY Facet Screw Fixation System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document [K012773](https://510k.innolitics.com/search/K012773) describes the predicate device and the new device being submitted. It states that "Biomechanical testing, including static and fatigue 3-Point PERFORMANCE DATA: Bend Testing and Cantilever Testing, were conducted" (from Document 1, [K012773](https://510k.innolitics.com/search/K012773) page 2, "Biomechanical testing"). However, the specific acceptance criteria (e.g., minimum strength, fatigue cycles) and the quantitative reported device performance for these tests are NOT provided in the extracted text. The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than detailing specific performance metrics against pre-defined acceptance criteria.

Therefore, the table below reflects the type of tests reported but cannot provide numerical acceptance criteria or performance due to the lack of this information in the provided input.

Acceptance Criteria (Type)	Reported Device Performance
Static 3-Point Bend Test (e.g., strength)	Details not provided in the document. Biomechanical testing was conducted.
Fatigue 3-Point Bend Test (e.g., cycles)	Details not provided in the document. Biomechanical testing was conducted.
Cantilever Test (e.g., strength, cycles)	Details not provided in the document. Biomechanical testing was conducted.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Biomechanical testing, including static and fatigue 3-Point PERFORMANCE DATA: Bend Testing and Cantilever Testing, were conducted." The sample size used for these biomechanical tests is not specified in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is biomechanical testing of a medical device (screws and washers), not a study analyzing medical images or clinical data where expert consensus would typically establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for a biomechanical testing study. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical imaging) to resolve discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable as the study described is biomechanical testing of a medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable as the study described is biomechanical testing of a medical device, not an evaluation of an algorithm's performance.

7. Type of Ground Truth Used

The ground truth for this type of study is typically established by engineering standards and physical measurements obtained from controlled laboratory conditions, using specialized testing equipment (e.g., material testing machines to measure load, displacement, and cycles to failure). The document does not explicitly state the specific standards used, but it refers to "Biomechanical testing."

8. Sample Size for the Training Set

This information is not applicable. Biomechanical testing of a physical device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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	VIII.	510(k) Summary
	SUBMITTER:	DePuy AcroMed™, Inc.325 Paramount DriveRaynham, MA 02780	NOV 1 6 2001K012773
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 ScrewTownley Transfacetpedicular Screw System (K003928)Townley Transfacet/Intrapedicular Screw (K994308)
	INTENDED USE:		The Discovery Facet Screw Fixation System is intended tostabilize the spine as an aid to fusion by two differentfixation methods:
			Transfacet fixation - The screws are inserted bilaterallythrough the superior side of the facet, across the facet jointand into the inferior pedicle.
			Translaminar-facet fixation - The screws are insertedbilaterally 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 posteriorsurgical treatment of any or all of the following at the L1 toS1 (inclusive) spinal levels: 1) Trauma, including spinalfractures and/or dislocations; 2) Spondylolisthesis; 3)Spondylolysis; 4) Pseudoarthrosis or failed previous fusionswhich are symptomatic or which may cause secondaryinstability or deformity; 5) Degenerative diseases whichinclude: (a) degenerative disc disease (ddd) as defined byneck and/or back pain of discogenic origin as confirmed bypatient history with degeneration of the disc as confirmedby radiographic studies and/or (b) degenerative disease ofthe facets with instability
	MATERIALS:	Manufactured from ASTM F-136 implant grade titaniumalloy.

$P^{1/2}$

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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.

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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

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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

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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.

(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

Regulation Number and Section

N/A