The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graff in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

Device Description

The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optima cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used either with or without the internal supplemental fixation provided (AeroTM-LL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The AeroTM-LL Fixation Anchors are constructed from titanium alloy (Ti 6Al-4V) and feature rails that mate with dovetail channels located within the AeroTM-LL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.

AI/ML Overview

The provided document outlines the 510(k) summary for the Stryker Spine Aero™-LL Lumbar Cage System, focusing on its substantial equivalence to predicate devices based on non-clinical testing. The document does not describe a study involving human readers or AI.

Here's an analysis of the provided information, structured around the requested criteria where applicable:

Acceptance Criteria and Device Performance

The acceptance criteria for the Aero™-LL Lumbar Cage System are based on demonstrating "substantially equivalent performance" to identified predicate devices through non-clinical mechanical testing, as per FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007).

The specific performance metrics are derived from various ASTM standards and internal draft standards for intervertebral body fusion devices. The device's performance is reported as meeting these criteria, demonstrating substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test)	Standard / Description	Reported Device Performance
Static Compression	Per ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Dynamic Compression	Per ASTM F2077	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Static Compression Shear	Per ASTM F2077	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Dynamic Compression Shear	Per ASTM F2077	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Static Torsion	Per ASTM F2077	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Dynamic Torsion	Per ASTM F2077	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Expulsion	Per ASTM F04-25-02-02 Draft (Likely a draft standard for intervertebral body fusion device expulsion resistance)	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Subsidence	Per ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices)	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to meet or exceed predicate device performance for this test)
Wear Debris Assessment	Not specified, but likely involves evaluating generation of wear particles from the device.	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to show acceptable wear characteristics compared to predicate devices)
Dynamic Cadaver Testing (Fatigue Performance)	Involves implantation into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes. (This is a more complex mechanical test simulating in-vivo conditions.)	"demonstrated substantially equivalent performance to the identified predicate device systems." (Implied to show durability and fatigue resistance comparable to predicate devices in a cadaveric model when subjected to various physiological loading modes.)

Study Information (Based on the provided document)

Since this document describes the substantial equivalence of a physical medical device (lumbar cage) based on mechanical testing, many of the requested AI/human-reader related study details are not applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of an AI study. For the mechanical tests, the "sample size" would refer to the number of devices or constructs tested for each mechanical test. This specific number is not provided in the 510(k) summary, but it would typically be a set number per ASTM standard (e.g., n=6 for certain tests).
- Data Provenance: The data is from non-clinical mechanical testing, performed in a laboratory setting. There is no geographical "country of origin for data" in the sense of patient data. The testing is retrospective in the sense that it's performed after design but before market release.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This pertains to AI performance evaluation where expert consensus defines ground truth. For mechanical testing, the "ground truth" is defined by the physical laws and engineering principles measured by the test equipment against the specified ASTM standards and predicate device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: This is an AI/human-reader concept. The "adjudication" for mechanical tests is implicit in the compliance with standardized test methods and data analysis by qualified engineers.
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 device, not an AI system that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This is a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Mechanical Performance Data / Predicate Equivalence: The "ground truth" for the Aero™-LL Lumbar Cage System is its mechanical performance as measured by standardized tests (e.g., ASTM F2077, ASTM F2267) which must be substantially equivalent to the established mechanical performance of legally marketed predicate devices. This type of ground truth is based on engineering specifications and physical testing results, not medical patient outcomes or expert consensus in a diagnostic sense.
The sample size for the training set:
- Not Applicable: This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not Applicable: Applies to AI models.

Summary

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

November 13, 2014

Stryker Spine Mr. Alan Traettino Senior Director, Regulatory and Clinical Affairs 2 Pearl Court Allendale, New Jersey 07401

Re: K142066

Trade/Device Name: Aero™-LL Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 20, 2014 Received: October 21, 2014

Dear Mr. Traettino:

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 - Mr. Alan Traettino

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 vours.

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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Indications for Use

510(k) Number (if known) K142066

Device Name Aero™-LL Lumbar Cage System

Indications for Use (Describe)

The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary: AeroTM-LL Lumbar Cage System
Submitter:	Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Contact Person	Alan TraettinoSenior Director, Regulatory and Clinical AffairsPhone: 201-760-8109Fax: 201-962-4109Email: alan.traettino@stryker.com
Date Prepared	October 20, 2014
Trade Name	AeroTM-LL Lumbar Cage System
Proposed Class	Class II
Classification Nameand Number	Intervertebral body fusion device, 21 CFR 888.3080
Product Code	OVD, MAX
Predicate Devices	The AeroTM-LL Lumbar Cage System was shown to besubstantially equivalent to the devices listed below:Primary Predicate Device:Stryker Spine AVS PL (K082014)Additional Predicate Devices:Stryker Spine AeroTM-AL Lumbar Cage System (K133328)Stryker Spine AVS Anchor-L (K120869)LDR Spine Avenue L (K113285)Depuy Synthes SYNFIX Lateral Spacer (K131276)
Device Description	The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optimacage surrounded by a titanium alloy (Ti-6Al-4V) jacket. ThePEEK Optima cage portion consists of two closed pockets forgraft containment and has serrations on the superior and inferiorsurfaces of the cage. The implant is designed to be used eitherwith or without the internal supplemental fixation provided(AeroTM-LL Fixation Anchors) in addition to supplementalfixation systems cleared for use in the lumbosacral spine. TheAeroTM-LL Fixation Anchors are constructed from titanium alloy(Ti 6Al-4V) and feature rails that mate with dovetail channelslocated within the AeroTM-LL PEEK cage. Once fully seatedinto the channels, the anchors are designed to lock into thetitanium jacket.
Intended Use andIndications for Use	The Stryker Spine AeroTM-LL is an intervertebral body fusiondevice indicated for use with autogenous bone graft in patientswith degenerative disc disease (DDD) at one level or twocontiguous levels from L2 to S1.DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients should
510(k) Summary: AeroTM-LL Lumbar Cage System
	be skeletally mature and have six months of nonoperativetherapy.
	The AeroTM-LL Lumbar Cage System is to be implanted via alateral approach.
	The AeroTM-LL Lumbar Cage System is intended to be usedwith supplemental spinal fixation systems that have been clearedfor use in the lumbosacral spine (e.g., posterior pedicle screwand rod systems). In addition, the device may be used with orwithout the included fixation anchors.
Summary of theTechnologicalCharacteristics	The subject AeroTM-LL Lumbar Cage System and the predicatesshare similar design features:• Graft windows for packing autogenous bone• Serrations on the superior and inferior surfaces• Comparable heights, widths, depths, and lordotic angles
Summary ofNon-Clinical Testing	Testing in compliance with FDA's June 12, 2007 "Class IISpecial Controls Guidance Document: Intervertebral BodyFusion Device" was performed for the AeroTM-LL LateralLumbar Cage System and demonstrated substantially equivalentperformance to the identified predicate device systems.The following mechanical tests were performed:• Static Compression (per ASTM F2077)• Dynamic Compression (per ASTM F2077)• Static Compression Shear (per ASTM F2077)• Dynamic Compression Shear (per ASTM F2077)• Static Torsion (per ASTM F2077)• Dynamic Torsion (per ASTM F2077)• Expulsion (per ASTM F04-25-02-02 Draft)• Subsidence (per ASTM F2267)• Wear Debris Assessment• Dynamic Cadaver Testing involving the implantation of theAeroTM-LL device into multiple functional spinal units andsubsequent evaluation of fatigue performance under multipleloading modes.
Conclusion	Based upon a comparison of intended use, technologicalcharacteristics, and device performance in the non-clinicaltesting listed above, the AeroTM-LL Lateral Lumbar CageSystem has demonstrated substantial equivalence to theidentified predicate device systems.

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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.