S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM by RENOVIS SURGICAL TECHNOLOGIES, LLC

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft.

Patients should be skeletally mature and have at least six months of non-operative treatment.

The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.

Device Description

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations.

The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct.

The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.

AI/ML Overview

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral fusion device. The acceptance criteria for the device were based on various mechanical performance tests as outlined by ASTM standards and specific FDA guidance documents. The study demonstrating the device meets these criteria involved physical performance testing of the device's components and the full implant system.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Standard)	Reported Device Performance
Static Compression per ASTM F2077	Successfully undergone
Dynamic Compression per ASTM F2077	Successfully undergone
Static Shear-Compression per ASTM F2077	Successfully undergone
Dynamic Shear-Compression per ASTM F2077	Successfully undergone
Expulsion Testing w/screws per ASTM Draft Standard F04.25.02.02	Successfully undergone
Expulsion Testing w/o screws per ASTM Draft Standard F04.25.02.02	Successfully undergone
Subsidence testing per ASTM F2267	Successfully undergone
Shear testing of metallic coatings per ASTM F1044	Sample coupons of Titanium porous structure successfully undergone testing
Tensile testing of metallic coatings per ASTM F1147	Sample coupons of Titanium porous structure successfully undergone testing
Abrasion per ASTM F1978	Sample coupons of Titanium porous structure successfully undergone testing
Porosity-and microstructure per ASTM F1854	Sample coupons of Titanium porous structure successfully undergone testing
Compliance with FDA Guidance: "Intervertebral Body Fusion Device"	Complies
Compliance with FDA Guidance: "Spinal System 510(k)s"	Complies
ASTM F 983-86 (Reapproved 2009) Standard Practice for Marking	Complies
ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care/Handling	Complies
ASTM F2026 Standard Specification for PEEK Polymers	Complies
ASTM F-136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI	Complies
ASTM F 560-08 Standard Specification for Unalloyed Tantalum	Complies
ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes	Complies
ASTM F138 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire	Complies

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

The document states that "worst case constructs" of the Renovis S128 ALIF System implants were used for mechanical testing and "sample coupons" of the Titanium porous structure were tested. However, the exact numerical sample sizes for each test are not specified in the provided text. The data provenance is pre-market performance bench testing, indicating it is prospective data obtained specifically for regulatory submission, and not from clinical trials or retrospective patient data. The country of origin for the data generation (e.g., in which lab/country testing was conducted) is not specified, though Renovis Surgical Technologies is located in Redlands, CA, USA.

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

This information is not applicable as the evaluation of this medical device's performance is based on standardized mechanical testing against pre-defined engineering criteria (ASTM standards and FDA guidance) rather than subjective expert assessment of clinical data or images. "Ground truth" in this context refers to the verifiable performance against these objective mechanical benchmarks.

4. Adjudication Method for the Test Set:

This information is not applicable as the device's performance was assessed through objective mechanical testing against established standards, not through a process requiring expert adjudication of subjective outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the document describes a pre-market notification for an intervertebral fusion device, which is an implantable medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or would be relevant.

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

This is not applicable as the device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation is defined by established engineering and material standards and FDA guidance documents. Specifically, successful performance in physical and mechanical tests (e.g., static/dynamic compression, shear, expulsion, subsidence) as per ASTM F2077, ASTM F2267, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1854, and various material specifications (e.g., PEEK, Titanium, Tantalum). The device's substantial equivalence is based on its ability to meet these objective, measurable criteria, indicating it performs comparably to predicate devices in mechanical integrity and material properties.

8. The Sample Size for the Training Set:

This information is not applicable. The context provided is for a traditional medical device (spinal implant) undergoing a 510(k) submission, which relies on demonstrating substantial equivalence through engineering testing and material characterization, not machine learning or AI models that require training sets.

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

This information is not applicable for the reasons stated in point 8.

Summary

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K131122 Page 1 of 5

Abbreviated 510(k) Summary as required by 21 CFR 807.92(a) K131122

A ) Submitted by:

Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571

Official Contact:

Anthony DeBenedictis Vice President of Quality Assurance

Consultant:

Sharyn Orton, Ph.D. MEDIcept, Inc. 200 200 Homer Ave Ashland, MA 01721

SEP 18 2013

Date Prepared: September 16, 2013

B) Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar

Common Name: Intervertebral body fusion device

Proprietary Name: S128 Anterior Lumbar Interbody Fusion (ALIF) System

Device Class: Class II - 888.3080

Regulation and 888.3080, OVD - Intervertebral body fusion device Product code:

Classification panel: Orthopedic

C) Predicates:
- K081177 Blackstone Orthofix Pillar .
- . K092211 K2M Chesapeake
- K123767 Lanx Lateral -SA System ●
- K 102738 Lanx Fusion System .
- . K083815 Lanx Fusion System
- K073144 Lanx Intervertebral Body Fusion Device .
- K082260 Calvary Spine Petra PLIF Cage System .

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D) Device Description:

E) Indications For Use:

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and . radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft.

Patients should be skeletally mature and have at least six months of non-operative treatment.

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K131122
Page 3 of 5

ORENOVIS

F) Substantial Equivalence Comparison and Discussio

	RenovisS128 ALIFSystem	Blackstone(Orthofix) PillarK081177	K2MChesapeakeK092211	LanxLateral SASystem K123767Fusions SystemK102738Fusion SystemK083815Intervertebralbody FusionDevice K073144	Calvary SpinePetra PLIF CageSystemK082260
Implant Material	PEEKTitanium	PEEK	PEEK	PEEKTitanium alloy	PEEK
Dimensions in mm
A/P	26, 28, 30	28, 32	24, 28, 30	16, 18, 22, 26	Crescent 13x 27
M/L	30, 34, 38	37, 40, 43	30, 36, 40	25 to 60	Straight 11 x 30
H	11-21	12.5 - 20	11-19	6-16	7-15
Lordosis	7°, 12°	7°, 12°	10°, 15°	0°, 8°
Screw material	Titanium	Titanium	Titanium	Titanium whenapplicable	Requiressupplementalfixation
Number of screws	4	4	3	Unk	80
Screw Diameter (mm)	4.5, 5.0	5.0, 5.5	5.5	Unk
Screw Length (mm)	20, 25, 30, 35	20, 25, 30, 35	20, 25, 30	Unk
Cover plate	Titanium	Titanium	Titanium	Unk	Tantalum
Marker material	Tantalum	Tantalum	Tantalum	Tantalum	Tantalum

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Conclusion

Based upon the same or similar intended use, design, function, technology, and materials, the Renovis S128 ALIF System is substantially equivalent to the predicate devices and does not raise new issues of safety or effectiveness.

G) Performance Testing

The Renovis S128 ALIF System implants (worse case constructs) have successfully undergone the following testing:

1. Static Compression per ASTM F2077
1. Dynamic Compression per ASTM F2077
1. Static Shear-Compression per ASTM F2077
1. Dynamic Shear-Compression per ASTM F2077
1. Expulsion Testing w/screws per ASTM Draft Standard F04.25.02.02
1. Expulsion Testing w/o screws per ASTM Draft Standard F04.25.02.02
1. Subsidence testing per ASTM F2267

Sample coupons of the Titanium porous structure have successfully undergone the following testing:

1. Shear testing of metallic coatings per ASTM F1044
1. Tensile testing of metallic coatings per ASTM F1147
1. Abrasion per ASTM F1978
1. Porosity-and microstructure per ASTM F1854

Conclusion

Performance data results support that the Renovis $128 ALIF System is substantially equivalent to the predicate devices and that there are no new issues of safety or effectiveness.

H) Compliance with FDA Guidance and Consensus Standards

The Renovis S128 ALIF System complies with the following:

FDA Guidance:

· Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007.
· Guidance for Industry and FDA Staff: Spinal System 510(k)s", May 2004 for labeling including labels, Instructions for Use and Surgical Manual

21 CFR 888.3080 Intervertebral body fusion device:

· ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components

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ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of -. Orthopedic Implants and Instruments
. ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
ASTM F2077-3 Test Methods for Intervertebral Body Fusion Devices .

Other

. ASTM F2026 Standard Specification for PEEK Polymers for Surgical Implant Applications
ASTM F-136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI . (Extra Low Interstitial) Alloy for Surgical Implant Applications, and
ASTM F 560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant . Applications
ASTM draft standard F.04.25.02.02 Static Expulsion ●
ASTM F1044-05(2011)e1 Standard Test Method for Shear Testing of Calcium Phosphate . Coatings and Metallic Coatings
ASTM F1147- 05(2011) Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
ASTM F1978 12 Standard Test Method for Measuring Abrasion Resistance of Metallic . Thermal Spray Coatings by Using the Taber Abraser
. ASTM F1854 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening . Stainless Steel Bars and Shapes
. ASTM F138 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

September 18, 2013

Renovis Surgical Technologies, LLC % Sharyn Orton, Ph.D. MEDIcept, Incoporated 200 Homer Avenue Ashland, Massachusetts 01721

Re: K131122

Trade/Device Name: Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: August 16, 2013 Received: August 19, 2013

Dear Dr. Orton.

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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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

Ronald P. Jean -S for

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 Form

510(k) Number (if known): K131122

Device Name: Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System

Indications for Use:

Patients should be skeletally mature and have at least six months of non-operative treatment.

X_____________________________________________________________________________________________________________________________________________________________________________ Over-the-Counter Use Prescription Use (21 CFR 801, Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH. Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Renovis S128 ALIF System

Abbreviated 510(k) Premarket Notification

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.