The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Trauma (including fractures).
Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis)
Pseudoarthrosis
Failed previous fusion
Spondylolisthesis
Spinal Stenosis
THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.
WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Device Description

The REGENT Anterior Cervical Plate System is composed of various cervical plates and screws made from a Titanium alloy (Ti-6Al-4V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the REGENT Anterior Cervical Plate System:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a modification to an already cleared device, primarily the addition of a self-drilling screw. The acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate device (K091134), particularly in terms of mechanical performance and material properties. Since it's a modification, the "acceptance criteria" are not absolute performance thresholds but rather a demonstration that the new component (self-drilling screw) does not negatively impact the overall system's safety and effectiveness compared to the predicate.

Acceptance Criteria Category (Implied for Substantial Equivalence to K091134)	Reported Device Performance (Proposed Device)
Mechanical Performance (Static Compression Bending and Torsion)	Substantially equivalent to the self-tapping screws used in the previously cleared REGENT Anterior Cervical Plate System (K091134), as per ASTM F1717.
Material Composition	Made from the same material as the predicate device's self-tapping screw: Ti-6Al-4V (ASTM F-136/ISO 5832-3).
Dimensional Characteristics (Screw Diameters & Lengths)	Provided in the same lengths and overall diameters (4.0mm and 4.5mm) as the predicate device's screws.
Interface with Plate (Screw to Plate Interface)	The proximal geometry of the subject self-drilling screw has an identical geometry to the self-tapping screw head (K091134), resulting in identical interfaces between the REGENT Anterior Cervical Plate.
Indications for Use	Same as the previously cleared system (K091134).
Anodization	Yes (Type II), same as the predicate.
Plate Dimensions	Same as the predicate.

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

Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical tests. It states "The self drilling screws and the cleared REGENT Anterior Cervical Plates were tested..." This suggests a sufficient number of samples were tested to meet the requirements of ASTM F1717.
Data Provenance: The data is based on non-clinical (mechanical) testing conducted by Custom Spine, Inc. The country of origin for the testing itself is not explicitly stated, but the company is based in Parsippany, NJ, USA. The study is prospective in the sense that the new self-drilling screws were manufactured and then tested.

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

Not applicable. This is a submission for a medical device which relies on objective mechanical testing data and comparison to a predicate device, not on expert-established ground truth for a diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. This refers to adjudication of discrepancies in human interpretation, which is not relevant for mechanical testing results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a mechanical device, not a diagnostic algorithm that involves human readers interpreting cases. Therefore, an MRMC study was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence is based on objective mechanical test standards (ASTM F1717) and direct comparison of material, design, and indications for use to a previously cleared predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model; therefore, there is no training set.

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

Not applicable. As there is no training set, there is no ground truth for a training set to establish.

Summary

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510(K) SUMMARY

Name of Firm

Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707 Date Prepared: April 23, 2010

MAY 1 9 2010

Official Correspondent

Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 265- 5036 Fax: (973) 808-0707 E-mail: saad@customspine.com

Establishment Number

3005129649

Device Name

Legally Marketed Trade Name: REGENT Anterior Cervical Plate System Common Name: Spinal Intervertbral Body Fixation Orthosis Device Classification: Class II Regulation Number: 21 CFR §888.3060 Device Product Code(s): KWQ

Predicate Device

REGENT Anterior Cervical Plate System (K091134)

Device Description

Indications for Use

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Degenerative Disc Disease (as defined by neck pain of discogenic origin with o degeneration of the disc confirmed by history and radiographic studies)

Trauma (including fractures). 0
Tumors 0
Deformities or curvatures (including kyphosis, lordosis or scoliosis) o
Pseudoarthrosis o
Failed previous fusion 0
Spondylolisthesis 0
Spinal Stenosis 0

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.

WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Materials

The REGENT Anterior Cervical Plate System contains implants (screws and plates) manufactured from Titanium (Ti-6Al-4V, ASTM F-136/ISO 5832-3). The system contains instruments and non-implantable devices manufactured from stainless steel.

LegallyMarketedName	REGENT Anterior Cervical Plate System	REGENT Anterior Cervical Plate System
PremarketSubmission	K091134	Proposed
Fixed ScrewDiameterand Lengths	4.0 mm dia – 10 mm through 20 mm4.5 mm dia – 12 mm through 20 mm	4.0 mm dia – 10 mm through 20 mm4.5 mm dia – 12 mm through 20 mm
VariableScrewDiametersand Lengths	4.0 mm dia – 10 mm through 20 mm4.5 mm dia – 12 mm through 20 mm	4.0 mm dia – 10 mm through 20 mm4.5 mm dia – 12 mm through 20 mm
Anodized	Yes (Type II)	Yes (Type II)
CervicalPlates	Level 1 Plate - 12 mm to 26 mmLevel 2 Plate - 26 mm to 46 mmLevel 3 Plate – 40 mm to 67 mmLevel 4 Plate - 60 mm to 84 mm	Level 1 Plate – 12 mm to 26 mmLevel 2 Plate - 26 mm to 46 mmLevel 3 Plate - 40 mm to 67 mmLevel 4 Plate - 60 mm to 84 mm

Predicate Device Comparison

Pg 2 of 4

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KIOIIS I

Predicate Device Comparison (Continued)
-----------------------------------------	--	--	--	--

510(k)	REGENT Anterior Cervical Plate System(Proposed Device)	REGENT Anterior Cervical Plate SystemCleared Device (K091134)
Characteristic
Screw Type	Self Drilling or Self Tapping are bothavailable for user preference	Self Tapping
Diameters/Lengths	4.0 mm: 10mm - 20 mm	4.0 mm: 10mm - 20 mm
	4.5 mm: 12 mm - 20 mm	4.5 mm: 12mm - 20 mm
IndicationsFor Use	Same As Previously Cleared System	The REGENT Anterior Cervical Plate System is intendedfor anterior intervertebral screw fixation of the cervicalspine at levels C2-T1. The system is indicated fortemporary stabilization of the anterior spine during thedevelopment of cervical spine fusions in patients withthe following indications:
		Degenerative Disc Disease (asdefined by neck pain ofdiscogenic origin withdegeneration of the discconfirmed by history andradiographic studies) Trauma (including fractures). Tumors Deformities or curvatures(including kyphosis, lordosis orscoliosis) Pseudoarthrosis Failed previous fusion Spondylolisthesis Spinal Stenosis
		THIS DEVICE IS ONLY TO BE USED IN SKELETALLYMATURE PATIENTS.
		WARNING: THIS DEVICE IS NOT INTENDED FOR SCREWATTACHMENT OR FIXATION TO THEPOSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL,THORACIC, OR LUMBAR SPINE.
Materials	Ti-6Al-4V (ASTM F-136 ISO 5832-3)	Ti-6Al-4V (ASTM F-136.ISO 5832-3)

Summary of Non-Clinical Test

The self drilling screws and the cleared REGENT Anterior Cervical Plates were tested in static compression bending and torsion. This was performed in accordance with ASTM F1717, "Standard Test Methods for Spinal Implants and Constructs of a Vertebrectomy Model ", and was considered substantially equivalent to the self tapping screws used in the previously cleared REGENT Anterior Cervical Plate System (K091134).

Summary of Clinical Test

Not Applicable.

Pa. 3 of L

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Basis for Substantial Equivalence

The basis for substantial equivalence is described in this substantially equivalent to the predicate devices based on similarities in design, intended use, and material. Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices. The addition of the self drilling screw has the following similarities

Intended Use: The proposed system has the same intended use as the previously clear

Materials: The proposed self drilling screws are made from the same material as the self tapping screw (Ti-6Al-4V, ASTM F-136, ISO 5832-3)

Lengths of the screws: The proposed lengths of the self drilling screws are provided in the same lengths and overall diameters (4.0mm and 4.5mm).

Mechanical Testing: The mechanical test results of the proposed self drilling screw device are substantially equivalent to the self tapping screw in the cleared REGENT Anterior Cervical Plate System (K091134).

Screw to plate interface: The proximal geometry of the subject self drilling screw has an identical geometry to the self tapping screw head (K091134), and result in identical interfaces between the REGENT Anterior Cervical Plate.

Modification to the device

The addition of an acute angle tip screw (self drilling) as an alternative to the self tapping screw . in the previously cleared REGENT ANTERIOR Cervical Plate System (K091134).
Pg 4 of 4.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Custom Spine, Inc. % Mr. Saad Attiyah Manager, Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, New Jersey 07054

MAY 1 9 2010

Re: K101151

Trade/Device Name: REGENT Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: April 20, 2010 Received: April 23, 2010

Dear Mr. Attiyah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{5}------------------------------------------------

Page 2 - Mr. Saad Attiyah

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

STOP 1

cerely vours.

Jarbare Buchner

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number : _ K ] Ol 1 5 | _______________________________________________________________________________________________________________________________________________

The REGENT Anterior Cervical Plate System is intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the 0 disc confirmed by history and radiographic studies)
Trauma (including fractures). O
Tumors 0
Deformities or curvatures (including kyphosis, lordosis or scoliosis) 0
Pseudoarthrosis 0
o Failed previous fusion
Spondylolisthesis 0
Spinal Stenosis O

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.

WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Prescription Use X

AND/OR

Over-The-Counter Use

(21 C.F.R. 807 Subpart C)

(Part 21 C.F.R. 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIO![2] 510(k) Number_

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.