The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

Device Description

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The system consists of implants and instruments. The implants consist of monoaxial and polyaxial pedicle screws of varying diameters and lengths, iliac screws, reduction screws, open and closed offset connectors, blockers, pre-contoured and straight Titanium alloy and straight cobalt chromium rods, and transverse connectors of varying lengths. All implants are made of titanium alloy except for the addition of CoCrMo Alloy rods and one commercially pure titanium component within the transverse connectors. Re-usable surgical instruments are provided to facilitate placement of the implants.

AI/ML Overview

The provided document is a 510(k) summary for the Zimmer Spine Instinct™ Java® System. It focuses on the substantial equivalence to predicate devices and does not describe a study involving patient data, clinical outcomes, or human readers for diagnostic purposes with AI assistance. Instead, it relies on engineering testing to demonstrate equivalence. Therefore, some of the requested information, such as expert ground truth, adjudication methods, MRMC studies, standalone performance with patient data, and training set information, is not applicable or available in this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Methods)	Reported Device Performance (Results)
Compliance with ASTM F1717-11a	Performance confirmed through compliance with ASTM F1717-11a
Compliance with ASTM F1798-97 (2008)	Performance confirmed through compliance with ASTM F1798-97 (2008)
Dynamic and static axial compression bending	Determination of substantially equivalent performance characteristics
Static torsion	Determination of substantially equivalent performance characteristics
Axial and torsional gripping capacity	Determination of substantially equivalent performance characteristics
Flexion-extension moment	Determination of substantially equivalent performance characteristics
AP(x) static pullout	Determination of substantially equivalent performance characteristics
Validated cleaning and sterilization instructions	Provided for nonsterile components of the system

2. Sample Size for the Test Set and Data Provenance

This document does not describe a test set involving patient data. The evaluation was based on engineering bench testing of the device components. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) is not applicable in this context. The "sample size" would refer to the number of device components tested, which is not specified but would be in line with the requirements of the ASTM standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The ground truth for device performance was established through compliance with recognized engineering standards (ASTM F1717-11a and ASTM F1798-97 (2008)) and demonstrated physical characteristics, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no human readers or diagnostic interpretations of patient data were involved in establishing the performance of the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe a clinical study (MRMC or otherwise) involving human readers or AI assistance. The evaluation focuses on the mechanical and material equivalence of the device to predicate devices through engineering testing.

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

Not applicable. This is not an AI/algorithm-based device in the sense of image analysis or diagnostic decision-making. Its performance is based on mechanical properties and material composition.

7. The Type of Ground Truth Used

The ground truth used was based on engineering standards and physical measurements of the device's mechanical properties, such as axial compression bending, static torsion, gripping capacity, flexion-extension moment, and AP(x) static pullout, as defined by ASTM F1717-11a and ASTM F1798-97 (2008).

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device evaluation.

Summary

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510(k) SUMMARY Zimmer Spine Instinct™ Java® System

JAN 4 2013

510(k) Number K122592

Date of Summary Preparation:

December 20, 2012

Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439

Submitter:

Company Contact:

Manufacturer:

Device Name:

Common Name:

Classification Name:

Product Code:

Regulation Number:

Device Classification:

Predicate Devices:

Elsa A. Linke

Regulatory Affairs

Zimmer Spine Cité Mondiale 23, parvis des Chartrons 33080 Bordeaux France

Instinct Java System

Spinal Fixation System

Pedicle Screw Spinal System

NKB, MNI, MNH

Class III

888.3070

Zimmer Spine Instinct™ Java® System, K111301, K113270

Zimmer Spine Sequoia Spinal System, K082032 Medtronic CD Horizon Solera System, K112473, K113174

Zimmer Spine Title 2 Polyaxial Spinal System, K073510

Description of Device:

The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mature patients and facilitate the biological process of spinal fusion. This system is intended for non-cervical posterior use in the thoracic, lumbar and sacral areas of the spine. The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal ' stenosis, kyphotic or lordotic spinal deformities, scoliosis, tumor and pseudoarthrosis or for revision of a failed previous fusion.

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The system consists of implants and.instruments. The implants consist of monoaxial and polyaxial pedicle screws of varying diameters and lengths, iliac screws, reduction screws, open and closed offset connectors, blockers, pre-contoured and straight Titanium alloy and straight cobalt chromium rods, and transverse connectors of varying lengths. All implants are made of titanium alloy except for the addition of CoCrMo Alloy rods and one commercially pure titanium component within the transverse connectors.

Re-usable surgical instruments are provided to facilitate placement of the implants.

In addition, the Instinct Java System is compatible with the transverse connectors currently cleared for the market as part of the Sequoia Spinal System, identified in K082032. Furthermore, the Instinct Java titanium rods may be connected to the NexLink Band & In-Line Rod Connector, identified in K062505, K060634, K052566, K052247, K031985.

The implants and instruments are provided non-sterile. Instructions for Use are provided that contain validated cleaning and sterilization instructions for the user.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion. This decision should be made based on the risk/benefit evaluation for each patient.

Intended Use:

Comparison of Technological Characteristics:

The objective of this 510(k) is to add larger polyaxial screws, reduction screws, CoCrMo rods, offset connectors and associated instruments. The Instinct Java Spinal System shares the same technological characteristics as the predicate devices. These characteristics include similar design, materials, range of sizes, technical requirements, and intended use. Determination of substantially equivalent performance characteristics in regard to the predicate devices was confirmed through compliance with ASTM F1717-11a and ASTM F1798-97 (2008), including dynamic and static axial compression bending, static torsion, axial and torsional gripping capacity, flexion-extension moment, and AP(x) static pullout. In addition, validated cleaning and sterilization are provided for the nonsterile components of the system.

Substantial Equivalence:

The Instinct Java Spinal System is substantially equivalent to the predicate devices in design, materials, function and intended use,

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

January 4, 2013

Zimmer Spine, Inc. % Ms. Elsa A. Linke Regulatory Affairs Project Manager 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K122592

Trade/Device Name: Zimmer Spine Instinct™ Java® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: December 20, 2012 Received: December 26, 2012

Dear Ms. Linke:

· 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. Elsa A. Linke

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 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.

Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The letters "Erin" and "th" are in a simple, bold font. The letters "I," "K," "e," and "i" are in a more complex, decorative font.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K122592

Device Name: Instinct™ Java® System

Indications for Use:

The Instinct Java spinal fixation system is designed for spinal fixation procedures in ' skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degeneralive disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic spinal deformities, scoliosis, tumor and pseudoarthrosis, or for revision of a failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122592

Regulation Number and Section

N/A