Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis, .
Trauma (i.e. fracture or dislocation), .
Spinal Stenosis.
Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
. Tumors.
. Pseudoarthrosis as a result of failed spine surgery,
Failed previous fusions, ●
Symptomatic cervical spondylosis, ●
Instability following surgery for the above indications. .
Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS Cervical Plating System is manufactured from Titanium Alloy/Phynox and will be provided non-sterile.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings based on the provided document:

This 510(k) submission (K121801) is for minor changes to the Quintex Cervical Plating System and seeks to demonstrate substantial equivalence to a previously cleared device (K100243). Therefore, the "acceptance criteria" are generally that the modified device performs similarly to or better than the predicate device in specified biomechanical tests.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Premarket Notification Purpose: Minor changes to Quintex screw and screwdriver should maintain or improve existing performance.	Device remains substantially equivalent to the current Quintex Cervical Plating System (K100243).
Overall Performance: The modified device must be substantially equivalent to the predicate device (K100243).	Biomechanical testing found the subject device to be similar in performance to the previously cleared system.
Specific Biomechanical Tests: The device must perform adequately in: - Off-axis screw insertion - Redirection of screw trajectory - Intentional pry-out	The results of these tests showed that the subject device meets or exceeds the performance of the predicate device, and is therefore found to be substantially equivalent.

Regarding the study proving the device meets acceptance criteria:

The study referenced is a non-clinical biomechanical testing program.

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (e.g., number of screws, plates, or constructs tested) for each biomechanical test.
- The data provenance is not explicitly stated beyond being "non-clinical testing" conducted as recommended by FDA Guidance for Spinal System 510(k)s. It's safe to assume this testing was conducted in a laboratory setting, likely in the US or a country with similar regulatory standards, but the specific location is not provided. The data is prospective in the sense that the tests were specifically designed and executed for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. Biomechanical testing of a medical device (like a spinal plating system) does not typically involve human experts establishing a "ground truth" for the test set in the way that image interpretation or diagnostic performance studies do. The "ground truth" here is the physical performance under controlled mechanical conditions, measured against engineering standards and comparison to a predicate device.
Adjudication method for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where human interpretation or clinical outcomes need to be resolved. For biomechanical testing, the "adjudication" is based on objective, quantifiable measurements and engineering analysis.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices, not for a spinal implant system undergoing biomechanical testing for substantial equivalence.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a passive mechanical implant, not an algorithm or a device with AI components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is the objective, quantitative performance data obtained from standardized biomechanical tests (e.g., force, displacement, failure load, rigidity, etc.), as measured and analyzed by engineers and compared against the performance characteristics of the predicate device and relevant engineering standards.
The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of biomechanical testing for a mechanical implant. Training sets are used in machine learning for AI algorithms.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of device and study.

Summary

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121801

Page 1 of 2

510(k) SUMMARY (as required by 21 CFR 807.92) B. Quintex Cervical Plating System SEP 1 1 2012 August 20, 2012 COMPANY: Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311 CONTACT: Lisa M. Boyle 800-258-1946 (phone) 610-791-6882 (fax) TRADE NAME: Quintex Cervical Plating System COMMON NAME: Anterior Cervical Screw Spinal Fixation System CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis (87KWQ)

REGULATION NUMBER: 888.3060

PURPOSE FOR PREMARKET NOTIFICATION

The Quintex Cervical Plating System described in this submission represents minor changes implemented to the Quintex screw and screwdriver.

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems (AIS), Inc., believes that the modifications to Quintex Cervical Plating System is substantially equivalent to the AIS Quintex Cervical Plating System (K100243).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:

. Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis, .
Trauma (i.e. fracture or dislocation), .

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Spinal Stenosis.
Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
. Tumors.
. Pseudoarthrosis as a result of failed spine surgery,
Failed previous fusions, ●
Symptomatic cervical spondylosis, ●
Instability following surgery for the above indications. .

Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

K121801

TECHNOLOGICAL CHARACTERISTICS (compared to Predicate(s)}

The AIS Quintex Cervical Plating System remains substantially equivalent to current Quintex Cervical Plating System (K100243). Biomechanical testing of the subject device was found to be similar in performance to previously cleared system.

PERFORMANCE DATA

As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate the Quintex Cervical Plaing System is substantially equivalent to the predicate device. The following testing was performed:

Off axis screw insertion .
Redirection of screw trajectory .
. Intentional Pry Out

The results of these tests showed that the subject device meets or exceed the performance of the predicate device, and the device is therefore found to be substantially equivalent.

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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 and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Public Health Service

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

Aesculap Implant Systems, LLC. % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

SEP 11 2012

Re: K121801

Trade/Device Name: Quintex Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 24, 2012 Received: August 27, 2012

Dear Ms. Boyle:

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 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

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Page 2 - Ms. Lisa Boyle

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/CDRH0ffices/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 Office of 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

yours,

Ron

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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Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

2121801 510(k) Number:

Device Name: Quintex Cervical Plating System

Indications for Use:

The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from:

Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis, .
Trauma (i.e. fracture or dislocation), .
Spinal Stenosis, ●
Deformity (i.e., scoliosis, kyphosis, and/or lordosis), ●
Tumors, ●
Pseudoarthrosis as a result of failed spine surgery, .
Failed previous fusions, .
Symptomatic cervical spondylosis .
Instability following surgery for the above indications. .

Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Concur

Carl- Rf-
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k/2/80/

002

Regulation Number and Section

N/A