When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

Who are receiving fusions with autogenous graft only; .
Who are having the device fixed or attached to the lumbar or sacral spine; .
Who are having the device removed after the development of a solid fusion mass. .

Device Description

The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonate-urethane).

AI/ML Overview

The K043565 510(k) submission for the Dynesys® Spinal System describes the device and its intended use, but it does not include acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

This document pertains to a traditional medical device (spinal fixation system) and its substantial equivalence to a predicate device, rather than an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this submission.

The relevant information from the provided text focuses on the comparison of technological characteristics for additional screw components to the existing Dynesys Spinal System, establishing substantial equivalence based on materials, design, and function.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated for AI/ML performance)	Reported Device Performance (Focus on material/design equivalence)
N/A (No AI/ML performance criteria specified)	Additional screw components demonstrate no technological differences from current Dynesys Spinal System components.
N/A (No AI/ML performance criteria specified)	Substantially equivalent to original Dynesys Spinal System components based on materials, design, and function.

Answers to Specific Questions (based on the provided text for a non-AI/ML device):

A table of acceptance criteria and the reported device performance: As shown above, specific performance metrics or acceptance criteria for an AI/ML component are not present. The "performance" described is the finding of substantial equivalence of additional screw components to the predicate device based on material, design, and function.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This submission concerns a physical medical device (spinal fixation system), not an AI/ML device requiring a test set of data. The testing mentioned refers to mechanical or physical characteristics of the screw components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No "ground truth" in the context of an AI/ML diagnostic or predictive model is established in this submission. The evaluation is based on engineering and design principles, and comparison to a predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the AI/ML sense to be adjudicated.
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: Not applicable. No AI component is described, so no MRMC study with AI assistance would have been conducted or reported here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm mentioned in this submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's substantial equivalence is the existing, legally marketed predicate device, and the engineering principles and standards applied to the new components.
The sample size for the training set: Not applicable. There is no AI/ML model that would require a training set.
How the ground truth for the training set was established: Not applicable. No training set is associated with this device submission.

Summary

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K043565 Page 1 of 2

510(k) SUMMARY

Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439
Company Contact:	Tim CrabtreeSenior Regulatory Affairs Specialist
Date Prepared:	December 15, 2004
Device Name:	Trade Name: Dynesys® Spinal SystemCommon Name: Spinal Fixation System.
Classification Name:	Posterior Metal/Polymer Spinal System, Fusion
Predicate Devices:	Dynesys® Spinal System (K031511)

Description of Device: The Dynesys Spinal System is comprised of a variety pedicle screws sizes, tensioning cords and longitudinal spacers that are uniquely fitted for each individual case. The pedicle screws are manufactured from medical grade titanium alloy. The tensioning cords are manufactured from Sulene-PET (polyethylene-terephthalate). The longitudinal spacers are manufactured from Sulene-PCU (polycarbonate-urethane).

Intended Use: When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

Who are receiving fusions with autogenous graft only; .
Who are having the device fixed or attached to the lumbar or sacral spine; .
Who are having the device removed after the development of a solid fusion mass. .

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K04 3565
Page 2 of 2

Comparison of Technological Characteristics:

Testing and analysis of proposed additional screw components for the Dynesys Spinal System was performed. The results of this testing demonstrated that the there are no technological differences between the proposed screw sizes and the components in the current Dynesys Spinal System.

Substantial Equivalence:

The additional components of the Dynesys Spinal System are substantially equivalent to the original Dynesys Spinal System components based on materials, design, and function.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like figure in the center. The bird is composed of three curved lines that suggest wings or feathers. The logo is encircled by text, which is arranged along the perimeter of the circle. The text is small and difficult to read, but it appears to be part of the organization's name or a related phrase.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Crabtree Senior Regulatory Affairs Specialist Zimmer Spine 7375 Bush Lake Road Minneapolis, Minnesota 55439

MAR 1 1 2005

Re: K043565

Trade/Device Name: Dynesys Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP Dated: February 10, 2005 Received: February 11, 2005

Dear Mr. Crabtree:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becales over is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in moreations for use stated in the enter, 1976, the enactment date of the Medical Device merslate commerce prior to that have been reclassified in accordance with the provisions of Amendments, or to devroes mat neve e Act (Act) that do not require approval of a premarket the reaclar Pood, Drug, and Ocomeasy, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the Field - 110 , 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), It may of backed to back 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 I lease be advised that 1 DT is losuines on that your device complies with other requirements mount that I Drima made statutes and regulations administered by other Federal agencies. of the Act of any I outh all the Act's requirements, including, but not limited to: registration r od intilet compty wart 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 es read on 1), a quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Tim Crabtree

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milliman

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number :Pending K043565

Device Name: Dynesys® Spinal System

Indications for Use: When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys Spinal System is indicated for use in patients:

Who are receiving fusions with autogenous graft only; .
Who are having the device fixed or attached to the lumbar or sacral spine; ◆
Who are having the device removed after the development of a solid fusion mass. .

f
Manh ke
(Division Sign-7)
Division of General, Restorative,

Neurologi Devices

510(k) Number: K043565

Prescription Use (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Exhibit 6 Page 1 of 1

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.