The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the S 100 Pedicle Screw System meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Evaluation Metric)	Reported Device Performance (S 100 Pedicle Screw System)
Static Compression Strength	Equal to, or higher than, predicate devices
Dynamic Compression Strength	Equal to, or higher than, predicate devices
Static Torsion Strength	Equal to, or higher than, predicate devices

Study Details

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 specify the sample size for the test set (number of devices tested).
- The data provenance is not explicitly mentioned, but the tests were performed "per ASTM F1717," which is an international standard for mechanical testing of spinal implant constructs. Without further information, it's presumed these were laboratory tests rather than human subject data.
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):
- This is not applicable as the study involved mechanical testing against a standard (ASTM F1717) rather than human interpretation or clinical outcomes requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical testing. The results are quantitative and objective based on the ASTM standard.
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:
- No MRMC study was conducted. The document explicitly states: "No clinical studies were performed." This is a mechanical device, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical pedicle screw system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the mechanical performance was the established mechanical properties and performance of legally marketed predicate devices, as well as the specifications outlined in ASTM F1717. The device's performance was compared to these existing standards and predicate devices.
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable as there was no training set.

Summary of the Study:

The study conducted for the S 100 Pedicle Screw System was a non-clinical, mechanical testing study designed to demonstrate substantial equivalence to predicate devices. The tests were performed according to ASTM F1717, which covers static and dynamic compression, and static torsion for spinal implant constructs.

The acceptance criteria were met by demonstrating that the mechanical performance (static and dynamic compression, static torsion) of the S 100 Pedicle Screw System was equal to, or higher than, the predicate devices. This means the device met or exceeded the established safety and performance benchmarks.

Since this was a physical medical device and not an AI or diagnostic tool, concepts like ground truth established by experts, clinical studies, MRMC studies, or training/test sets for algorithms are not applicable and were explicitly stated as not performed (e.g., "No clinical studies were performed"). The regulatory approval (510(k)) was based solely on demonstrating substantial equivalence through these non-clinical, mechanical tests.

Summary

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for the S 100 Pedicle Screw System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the S 100 Pedicle Screw System

Date Prepared: July 1, 2011

1. Submitter:
  Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374

2. Contact Person:

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 512-6923699 ortho.medix@sbcglobal.net

2. Trade name:	S 100 Pedicle Screw System
Common Name:	pedicle screw system
Classification Name:	orthosis, spondylolisthesis spinal fixation/ MNH/ 888.3070
	orthosis, spinal pedicle fixation/ MNI/ 888.3070
	Class II

ന് Predicate or legally marketed devices which are substantially equivalent:

Renovis S 100 Pedicle Screw System -ZODIAC™ Polyaxial Spinal Fixation - K042673 (Alphatec Spine Co) Xia3 - K071371 & K083393 (Stryker Spine)

4. Description of the device:

The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

Materials:

The components are manufactured from titanium alloy ELI (ASTM F136), CP titanium Grade 4(ASTM F67) and CoCrMo (ASTM F1537.

Function:

The S 100 Pedicle Screw System is intended to provide immobilization of spinal segments until fusion takes place.

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K111940

5. Substantial equivalence claimed to predicate devices:

The S 100 Pedicle Screw System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

દ. Intended Use:

The Renovis S 100 Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

Summary of Nonclincal Tests: 7.

The following tests were conducted:

. Testing per ASTM F1717 (static and dynamic compression, and static torsion)
The results of this testing was compared to predicate devices, with the results being equal to, or higher, than the predicates.

8. Clinical Test Summary:

No clinical studies were performed

9. Conclusions Nonclinical and Clinical:

The Renovis S 100 Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and method of assembly.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.

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

Renovis Surgical Technologies, LLC % The OrthoMedix Group Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, Texas 78681

MAY 1 5 2012

Re: K111940

Trade/Device Name: S 100 Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: February 06, 2012 Received: April 19, 2012

Dear Mr. Webb:

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. J.D. Webb

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

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

Enclosure

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Indications for Use

KII 1940

510(k) Number (if known):

Device Name: Renovis S 100 Pedicle Screw System

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII1940 510(k) Number_

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.