The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.

The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.

Device Description

The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.

The PIVOX™ Oblique Lateral System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft or allograft and must be used with supplemental fixation. The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral System plate and bone screws are made from titanium alloy and are provided sterile.

The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PIVOX™ Oblique Lateral Spinal System, which is a medical device for spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and biocompatibility assessments. It does not contain information about studies involving human readers, AI, or clinical ground truth derived from expert consensus, pathology, or outcomes data in the context of device performance evaluation as one might find in an AI/ML device submission.

Therefore, many of the requested elements are not applicable to the information contained in this 510(k) summary. I can, however, extract the relevant acceptance criteria, reported performance, and details about the studies reported.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." However, the specific numerical acceptance criteria values for each test are not explicitly detailed in the provided text; only that they were met.

Test Type	Acceptance Criteria (Not explicitly stated, but "pre-determined" and "met")	Reported Device Performance (Met Acceptance Criteria)
For Interbody Cages:
Static Compression	(Implicitly met pre-determined criteria)	Met
Static Compression Shear	(Implicitly met pre-determined criteria)	Met
Compression Fatigue	(Implicitly met pre-determined criteria)	Met
Compression-Shear Fatigue	(Implicitly met pre-determined criteria)	Met
Subsidence	(Implicitly met pre-determined criteria)	Met
Expulsion	(Implicitly met pre-determined criteria)	Met
For Plates and Screws:
Construct Static Compression	(Implicitly met pre-determined criteria)	Met
Construct Compression Fatigue	(Implicitly met pre-determined criteria)	Met
Construct Static Torsion	(Implicitly met pre-determined criteria)	Met
Static Push-Out	(Implicitly met pre-determined criteria)	Met

2. Sample Size Used for the Test Set and Data Provenance

This submission pertains to mechanical and biocompatibility testing of a physical implant device, not a data-driven AI/ML model for diagnostic or prognostic purposes. Therefore, the concepts of "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI studies are not applicable here.

The tests were conducted according to ASTM standards for spinal implants (ASTM F1717, F2077, F2267, and F-04.25.02.02). The sample sizes (number of constructs or samples tested) for these specific mechanical tests are not explicitly mentioned in the provided text.

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 this device's performance is established through standardized laboratory mechanical testing based on engineering principles and material science, not through expert human interpretation of medical images or other data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to expert discrepancies in establishing ground truth for diagnostic AI, which is not relevant to this device's testing.

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 a physical spinal implant, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This question relates to AI algorithm performance for diagnostic/prognostic tasks, which is not relevant to this device.

7. The Type of Ground Truth Used

The "ground truth" for the PIVOX™ Oblique Lateral Spinal System is established through pre-defined engineering specifications and performance standards for medical implants, primarily determined by:

Mechanical Testing Standards: Adherence to ASTM standards (F1717, F2077, F2267, F-04.25.02.02) which define how mechanical properties (e.g., strength, durability, resistance to subsidence/expulsion) are measured and what qualifies as acceptable performance for a device of this type.
Biocompatibility Standards: Compliance with ISO-10993 for biological evaluation, confirming the safety of materials (PEEK, titanium alloy, tantalum, stainless steel, silicone) for long-term implantation, relying on material specifications and a history of safe use.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning models. This submission describes an implantable medical device undergoing mechanical and biocompatibility testing. The "design verification testing" is analogous to a validation step rather than a training process.

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

Not applicable, as there is no "training set" in the context of this device's submission. The ground truth for evaluating the device's substantial equivalence is established by universally recognized engineering and material science standards and guidance documents for spinal implants.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized representation of three human profiles. The profiles are stacked on top of each other, creating a sense of unity and connection. The seal is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.

November 13, 2015

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

Medtronic Sofamor Danek USA, Incorporated Ms. Lila Joe Principle Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K152277

Trade/Device Name: PIVOX™ OBLIQUE LATERAL SPINAL SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, KWQ Dated: October 9, 2015 Received: October 13, 2015

Dear Ms. Joe:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K152277 Page 1 of 1

510(k) Number (if known)

K152277

Device Name PIVOX™ Oblique Lateral Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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PIVOX® Oblique Lateral Spinal System 510(k) SUMMARY November 2015

I. Submitter Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 (901)396-3133 Contact Lila Joe Principle Regulatory Affairs Specialist Date Prepared November 12, 2015 II. Device Name of Device PIVOX™ Oblique Lateral Spinal System Classification Name Intervertebral Body Lumbar Fusion Device with Bone Graft (CFR 888.3080) Spinal Intervertebral Body Fixation Orthosis (CFR 888.3060) Classification Class II MAX, OVD (Interbody Cages) Product Codes KWQ (Plates and Screws) Predicates There are 7 Predicates. Primary Predicate DIVERGENCE™-L™ Anterior Oblique Lumbar . Fusion System (K150135 - S.E. 06/11/2015) Additional Predicates ● CLYDESDALE® Spinal System K151128 (S.E. 08/06/2015) . CLYDESDALE® Spinal System
- K133577 (S.E. 09/26/2014)

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PERIMETER® Interbody Fusion Device K131669 (S.E. 11/01/2013)
PYRAMID® +4 Anterior Lumbar Plate System ● K071416 (S.E. 11/01/2007)
ZPLATE II™ Anterior Fixation System ● K991460 (S.E. 05/19/1999).
CD HORIZON® Spinal System ● K091442 (S.E. 07/15/2009)

III. Product Description

The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.

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The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

Indications for Use: IV.

The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.

V. Comparison of Technological Characteristics

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The primary predicate for the PIVOX™ Oblique Lateral Spinal System is the CLYDESDALE® Spinal System (K151128, S.E. 08/06/2015)

The subject PIVOX™ Oblique Lateral Spinal System interbody cages have the same or similar indications, intended use, fundamental scientific technology, and similar materials as the following FDA cleared predicates K151128 (S.E. 08/06/2015) and K131669 (S.E. 11/01/2013).

The subject PIVOX™ Oblique Lateral Spinal System plates and bone screws have the same intended use, fundamental scientific technology, material, and similar indications as the following FDA cleared predicates K071416 (S.E. 11/01/2007), K991460 (S.E. 05/19/1999). K091442 (S.E. 07/15/2009), and K150135 (S.E. 06/11/2015).

VI. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the subject PIVOX™ Oblique Lateral Spinal System interbody cages, plates, and bone screws was conducted in accordance with the FDA's Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.

The subject devices are manufactured from ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The subject plates, bone screws, and interbody cages are permanent implants and will be classified as "Implant Devices - Tissue/bone - C Permanent (>30 days)" according to FDA's Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.

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Polyetheretherketone (PEEK), titanium alloy, and tantalum have a long history of safe and effective use in predicate spinal implants. Therefore. no new biocompatibility testing was required.

The subject trials, inserters, and interbody remover are manufactured from:

Silicone (Elastosil® liquid silicone rubber) .
medical grade stainless steel per ●
- ASTM A564, Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes, or
- ASTM F899, Standard Specification for Wrought Stainless Steel for । Surgical Instruments

The subject instruments are classified as limited, up to 24 hours of body contact according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, issued April 23, 2013.

The silicone rubber is used to manufacture instrument handles, which are non-patient contacting. Therefore, no new biocompatibility testing was required according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.

Medical grade stainless steel has a long history of safe and effective use in spinal surgery and no new biocompatibility testing was required.

Mechanical Testing

In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.

Design verification testing was completed in accordance with

ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
ASTM F2077, Test Methods for Intervertebral Body Fusion Devices -
ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence । of Intervertebral Body Fusion Device Under Static Axial Compression

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- ASTM F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices

The tests completed were: For the Interbody Cages

Static Compression -
Static Compression Shear -
Compression Fatigue -
Compression-Shear Fatigue -
Subsidence -
Expulsion -

For the Plates and Screws

Construct Static Compression -
Construct Compression Fatigue -
Construct Static Torsion -
-Static Push-Out

The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests.

VII. Conclusions

Design verification testing was completed in accordance with ASTM F1717, ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02. Based on the test results and additional supporting information provided in this pre-market notification, Medtronic believes the subject devices demonstrated substantial equivalence to the legally marketed predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.