The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

Device Description

The uCentum™ comprehensive posterior system consists of rods, polyaxial pedicle screws and crosslinks with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available straight and curved in a variety of lengths. Polyaxial screws are available in a variety of diameterlength combinations. Crosslinks are offered in five lengths. The system can be implanted in open or minimally invasive procedures. The uCentum™ system components are manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the uCentum™ comprehensive posterior system:

The provided text is a 510(k) summary for a medical device (spinal system). It outlines the rationale for substantial equivalence to predicate devices, primarily based on design and mechanical performance, rather than clinical performance data with specific acceptance criteria that would typically be seen in a study evaluating diagnostic accuracy or a new therapeutic efficacy.

Therefore, there isn't a traditional "study" in the sense of a clinical trial with human subjects proving performance against specific acceptance criteria for diagnostic accuracy or clinical outcomes. Instead, the "study" referred to is a mechanical testing comparison to establish substantial equivalence.

Here's the breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Substantially equivalent to predicate devices based on ASTM F1717 for - Static compression bending - Dynamic compression bending - Static torsion	The mechanical test results demonstrated that uCentum™ performance is substantially equivalent to the predicate devices.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a human test set. The "test set" refers to the mechanical constructs of the uCentum™ system. The document does not specify the number of constructs tested, only that "worst case uCentum™ constructs" were included.
- Data Provenance: Not applicable in the context of human data. The data is generated from laboratory mechanical testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for mechanical testing is based on established engineering principles and standards (ASTM F1717), not expert human interpretation.
Adjudication Method for the Test Set:
- Not applicable. Adjudication is typically used for human-reviewed data, not mechanical test results.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not pertinent to the mechanical testing of a spinal implant.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
The Type of Ground Truth Used:
- The "ground truth" for the mechanical performance comparison is the established performance characteristics of the predicate devices as defined by ASTM F1717 testing. The uCentum™ system is compared against these benchmarks to demonstrate substantial equivalence.
The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical device. This concept is typically associated with machine learning algorithms.
How the Ground Truth for the Training Set was Established:
- Not applicable, as no training set was used.

Summary

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K123717

page 1 of 2

MAR 0 4 2013

Image /page/0/Picture/3 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" being larger than the other letters. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary

Date: Sponsor:

	28 November 2012
	ulrich GmbH & Co. KG
	Buchbrunnenweg 12
	89081 Ulm
	Germany
Phone:	+49 (0) 731-9654-1304
Fax:	+49 (0) 731-9654-2802
	Hans Stover

Contact Person:

ulrich medical USA, Inc. 612 Trade Center Blvd. Chesterfield, MO 63005 (636) 519-0268 Office (636) 519-0271 Fax

Contact Person:

Proposed Trade Name: Device Classification Classification Name:

Regulation: Device Product

Code:

Class II and Class III

Pedicle screw spinal system

uCentum™ comprehensive posterior system

888.3070

MNI, MNH, NKB

Submission Purpose:

Submission Purpose: This submission adds modified components (screw, rod and crosslink options).

Device Description:

Intended Use:

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K123717

and the comments of the comments of the comments of the contraction of the consisted on

and the comments of the comments of

Materials:	The uCentum™ system components are manufactured from titaniumalloy (Ti-6Al-4V ELI) as described by ASTM F136.
Predicate Devices:	tangoRS™ (K052385 and K120891)flamenco™ (K102853)Moss Miami (K992168/K022623)Revlock™ Fenestrated Screw System (K110280)
Performance Data:	Mechanical testing of the worst case uCentum ™ constructs includedstatic and dynamic compression bending, and static torsionaccording to ASTM F1717.The mechanical test results demonstrated that uCentum™performance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The uCentum™ comprehensive posterior system possesses thesame technological characteristics as one or more of the predicatedevices. These include:• performance (as described above),• basic design (rod-based, having screw anchors),• material (titanium alloy) and• sizes (dimensions are comparable to those offered by thepredicate systems).Therefore the fundamental scientific technology of the uCentum™comprehensive posterior system is the same as previously cleareddevices.
Conclusion:	The uCentum™ comprehensive posterior system possesses thesame intended use and technological characteristics as the predicatedevices. Therefore the uCentum™ comprehensive posterior systemis substantially equivalent for its intended use.

and the comments of the comments of the comments of the comments of

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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 eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.

Public Health Service

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

March 4, 2013

ulrich GmbH & Company KG % ulrich medical USA, Incorporated Mr. Hans Stover 612 Trade Center Boulevard Chesterfield, Missouri 63005

Re: K123717

Trade/Device Name: uCentum™ comprehensive posterior system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: November 28, 2012 Received: December 4, 2012

Dear Mr. Stover:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave a sove 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 for ass sured in the 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 and Cosmetto her (rect). Tot ). " on imigations described below. The general controls provisions of the provisions of the riot and the mixed registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions/Warnings/Contraindications section of the device's labeling:

"The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye."

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2 - Mr. Hans Stover

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the de rice results in a classinoon you to begin marketing your device as described in your Section 5 I0(k) premarket notification if the limitation statement described above is added to your labeling.

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 or any I vith 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 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 note the regulation of 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christy L. Foreman

Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K123717

Device Name: uCentum™ comprehensive posterior system

Indications for Use:

The uCentum™ comprehensive posterior system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the uCentum is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, and/or lordosis), fracture, spinal tumor, pseudarthrosis and failed previous fusion.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald®: Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123717

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.