TANGORS POLYAXIAL SYSTEM by ULRICH GMBH & CO. KG

The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the tangoRS Polyaxial System 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, and spinal tumor.

Device Description

The tangoRS Polyaxial System includes screws (preassembled), a locking screw, rod and cross links.

AI/ML Overview

The provided text is a 510(k) summary for the tangoRS Polyaxial System, a pedicle screw spinal fixation system. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-based performance.

The document describes the device, its intended use, and its classification, and confirms that the FDA found it substantially equivalent to predicate devices. It mentions that "Performance data were submitted," but does not detail what that performance data entailed, what the acceptance criteria were, or the results of any specific studies related to its performance characteristics against predefined criteria.

Therefore, I cannot provide the requested information for the following reasons:

Acceptance Criteria and Reported Device Performance: This information is not present in the provided text. The document is about regulatory clearance, not a performance evaluation against specific metrics.
Sample Size for Test Set and Data Provenance: Not applicable as no diagnostic or AI-based performance study is described.
Number of Experts and Qualifications: Not applicable as no ground truth establishment for a test set is described.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance Study: Not applicable.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

The document focuses on the regulatory approval process (510(k) clearance) for a medical device that provides immobilization and stabilization of spinal segments. The "Performance Data" mentioned likely refers to mechanical testing, biocompatibility, and other engineering-related assessments required for spinal implants, rather than clinical performance data in the way one might evaluate a diagnostic AI device.

Summary

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Ko52385

tangoRS Polyaxial System 510(k) Application

DEC 2 7 2005

PREMARKET NOTIFICATION 510(K) SUMMARY

Company:	Ulrich GmbH & Co. KGBuchbrunnenweg 12D-89081 UlmGermany+49 (0) 731 9654-110/225 (phone)+40 (0) 731 9654-2702 (fax)
Company Contact:	Christoph Ulrich
Date:	August 26, 2005
Trade Name:	tangoRS Polyaxial System
Common Name	Pedicle Screw Spinal Fixation System
ClassificationCode:	Orthopedics, 888.3070, MNI, MNH, NKB
Device Description:	The tangoRS Polyaxial System includes screws(preassembled), a locking screw, rod and cross links.
Intended Use:	The tangoRS Polyaxial System is intended to provideimmobilization and stabilization of spinal segments asan adjunct to fusion of the thoracic, lumbar and sacralspine. When used as a posterior spine thoracic/lumbarsystem, the tangoRS Polyaxial System is intended forthe following indications: degenerative disc disease (asdefined by back pain of discogenic with degeneration ofthe disc confirmed by patient history and radiographicstudies), spinal stenosis, spondylolisthesis, spinaldeformities (i.e., degenerative scoliosis, kyphosis,and/or lordosis), fracture, and spinal tumor.
Predicate Device:	Predicate device information is included.
Performance Data:	Performance data were submitted.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

Ulrich GmbH & Co. KG c/o Ian Gordon Senior Vice President EmergoGroup, Inc. 2519 McMullen Booth Rd. Clearwater, Florida 33761

Re: K052385

Trade/Device Name: tangoRS Polyaxial System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: August 26, 2005 Received: August 30, 2005

Dear Mr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clediosure fo regally manatise possible in the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaecential with the provisions of the Federal Food. Drug. devices that have been recatismed in acceraaned who f a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merclore, mance the device, belyer is the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the free from the read.
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 (PMA), it If your device is classified (soc aborto) als. Existing major regulations affecting your device can inay be subject to such additional consoler Lines. Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of Pounts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial cquivalence determination does not mean Please be advised that I DA s issualite of a backaria. I miles with other requirements of the Act that 117A has made a dolorimation administered by other Federal agencies. You must of any rederal statutes and regulations administry, but not limited to: registration and listing (21 Comply with an the Her STequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Ian Gordon

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This letter will anow you to oegin mailteans your device of your device of your device to a legally premarket notincation: "The PDF intelling of 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), please 11 you desire specific at Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Colline to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Co Mark N. Metkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number (if known): KOS23 8S

Device Name: tangoRS Polyaxial System

Indications for Use:

degenerative disc disease (as defined by back pain of discogenic with . degeneration of the disc confirmed by patient history and radiographic studies),
spinal stenosis, .
spondyloiisthesis, .
spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or . lordosis),
fracture, and .
spinal tumor. .

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ X or (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard S

eral, Rest rative,

510(k) Number K062385

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.