When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors

The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

Device Description

The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a new device's performance. Therefore, many of the requested categories of information are not present in the document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's clinical application. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Criteria Type	Description (from text)	Reported Device Performance (from text)
Substantial Equivalence	"Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner."	The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
Indications for Use	The device is indicated for promoting fusion of the cervical spine and the thoracic spine (C1-T3) for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. Hooks and rods also provide stabilization for fracture/dislocation or trauma in C1-T3. Screws are limited to T1-T3. Connectors allow linkage to other Endius spinal systems.	The FDA letter acknowledges the indications for use as stated and grants clearance based on substantial equivalence.
Material Composition	Fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.	Implied compliance through substantial equivalence to predicate devices which would also use biocompatible, high-grade materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the context of human data. The assessment for substantial equivalence appears to be based on:

Mechanical Test Results: The document mentions "mechanical test results" were provided to demonstrate substantial equivalence. No sample size for these tests is given, nor is their provenance.
Comparison to Predicate Device: The primary "data" seems to be a comparison to the predicate device (Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K070282) regarding design, materials, and indications for use.

3. 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 clinical test set with a "ground truth" established by experts is mentioned. The submission is a 510(k) for a spinal fixation system, not a diagnostic or AI device requiring expert ground truth for performance evaluation in a clinical setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is described.

5. 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. This is not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground for the "proof" of the device is its substantial equivalence to a previously cleared predicate device, based on similar design principles, materials, indications, and mechanical performance.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

K080258

Endius, Inc. 510(k) Premarket Notification Endius Minit PCT System January 30, 2008 Section 5 - 510(k) Summary

5.1 Statement

MAR 1 0 2008

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Endius, Inc. chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the modified device. Endius Minit Posterior Cervical and Upper Thoracic Fixation System is provided below.

5.2 Submitter

Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 Establishment Registration #: 1057469

5.3 Company Contact

Regina Wagner Manager, Regulatory Affairs/Quality Assurance (508) 643-0983 x107 regina.wagner@zimmer.com

5.4 Device Name

Proprietary Name: Endius Minit Posterior Cervical and Upper Thoracic Fixation System Classification Name: Spinal Interlaminal Fixation Orthosis Regulatory Class . Hr .. Product Code: KWP, NKB, MNI, MNH Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070

000014

ge 1/2

{1}------------------------------------------------

Endius, Inc. 510(k) Premarket Notification Endius Minit PCT System January 30, 2008 5.5 Predicate Devices

Device Name(s) & 510(k) Number:

� Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K070282.

5.6 Device Description

5.7 Device Indications and Intended Use

When intended to promote fusion of the cervical spine and the thoracic spine. (C1-T3). the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors

5.8 Substantial Equivalence

. Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner.
000012

Page 2/2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endius, Inc. % Ms. Regina Wagner 23 West Bacon Street Plainville, MA 02762

MAR 1 0 2008

Re: K080258

Trade/Device Name: Endius Minit Posterior Cervical and Upper Thoracic Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: January 30, 2008 Received: January 31, 2008

Dear Ms. Wagner:

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.

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 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); 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.

{3}------------------------------------------------

Page 2 - Ms. Regina Wagner

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millican

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

Enclosure

{4}------------------------------------------------

Endius, Inc. 510(k) Premarket Notification Endius Minit PCT System January 30, 2008

Indications for Use

510(k) Number (if known): K07xxxx

Device Name: Endius Minit Posterior Cervical and Upper Thoracic Fixation System

Indications For Use:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors

X 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Next RP Gal form

Page 1 of 1_________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of General Resto

Division of General. Restorative. and Neurological Devices

000010

510(k) Number C080258

Regulation Number and Section

N/A