The Reform Pedicle Screw System is intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The Reform Pedicle Screw System is to be used with autograft and/or allograft.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Reform Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. The pedicle screws are included with or without hydroxyapatite (HA) coating

AI/ML Overview

The provided text is a 510(k) Summary for the "Reform Pedicle Screw System" and does not contain information about acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria.

Instead, this document is a regulatory submission for a physical medical device (pedicle screws) and details its substantial equivalence to previously cleared predicate devices. The evaluation focuses on materials, design, intended use, dimensions, and mechanical strength, primarily through non-clinical (bench) testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the given input. The requested categories of information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are relevant to AI/ML device evaluations but are not present in this document about a traditional implantable medical device.

Summary

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May 19, 2020

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Precision Spine % Mr. J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K200303

Trade/Device Name: Reform Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: April 7, 2020 Received: May 14, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200303

Device Name

Reform Pedicle Screw 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)

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510(k) Summary: Reform® Pedicle Screw System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

Date Prepared	April 6, 2020
Submitted By	Precision Spine, Inc.2050 Executive DrivePearl, MS 39208
Primary Contact	J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810jdwebb@orthomedix.net
Secondary Contact	Michael C. DawsonPrecision Spine2050 Executive DrivePearl, MS 39208973-455-7150 ext. 128
Trade Name	Reform Pedicle Screw System
Common Name	Thoracolumbosacral Pedicle Screw SystemAppliance, Fixation, Spinal Interlaminal
Classification Name	Thoracolumbosacral Pedicle Screw SystemSpinal Interlaminal Fixation Orthosis
Class	II
Product Code	NKBKWP
CFR Section	21 CFR section 888.3070 and 888.3050
Device Panel	Orthopedic
Primary PredicateDevice	Reform Polyaxial Pedicle Screw System - Precision Spine, Inc. (K150856)
Secondary PredicateDevices	Reform HA Coated Pedicle Screw System - Precision Spine, Inc. (K151422)Firebird Spinal Fixation System - Orthofix, Inc. (K122901)
Device Description	The Reform System is a top-loading, multiple component, posterior spinal fixation systemwhich consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks,domino connectors, and lateral offset connectors. All of the components are available ina variety of sizes to match more closely to the patient's anatomy. The pedicle screws areincluded with or without hydroxyapatite (HA) coating
Materials	Cobalt chromium alloys (ASTM F1537, ISO 5832-12)Titanium alloy (ASTM F136, ISO 5832-3)Hydroxyapatite (HA) (ASTM F1185)
Intended Use	The Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System areintended 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 chronicinstabilities or deformities of the thoracic, lumbar, and sacral spine.
SubstantialEquivalence Claimedto Predicate Devices	The Reform Pedicle Screw System and Reform HA Coated Pedicle Screw Systemare substantially equivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances.
Indications for Use	The Reform Pedicle Screw System is intended for immobilization and stabilization ofspinal segments in skeletally mature patients as an adjunct to fusion in the treatment ofthe following acute and chronic instabilities or deformities of the thoracic, lumbar, andsacral spine: degenerative disc disease (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies), spondylolisthesis,fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis),spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. The ReformPedicle Screw System is to be used with autograft and/or allograft.When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, theReform Pedicle Screw System implants are indicated as an adjunct to fusion to treatprogressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathicscoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ReformPedicle Screw System is intended to treat pediatric patients diagnosed withspondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis,and/or failed previous fusion. This system is intended to be used with autograft and/orallograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseThe Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System and thepredicate devices are all intended to be used for immobilization and stabilization of spinalsegments.MaterialsThe Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System use thesame material as the predicates.DesignThe Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System and thepredicates are equivalent in terms of shape and function.DimensionsThe Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System and thepredicates are equivalent in their dimensions.StrengthThe Reform Pedicle Screw System and Reform HA Coated Pedicle Screw System havegreater or equivalent strength values compared to the predicates.
Non-clinical TestSummary	The following analyses were conducted:● Static and dynamic axial compression bending - ASTM F1717● Static torsion - ASTM F1717● Integrity of Package Seals - ASTM F1886● Package Seal Strength - ASTM F88● Detecting Seal Leaks - ASTM F1929● Testing of Shipping Containers - ASTM D4169● Detecting Leaks in Medical Packaging - ASTM F2096● Bacterial Endotoxins - Test Methods, routine monitoring, and alternatives tobatch testing - AAMI ST72:2019● Medical Devices – Bacterial Endotoxin and Pyrogen Test - USP <161>● Bacterial Endotoxin Test - USP <85>The results of these evaluations indicate that the Reform Pedicle Screw System andReform HA Coated Pedicle Screw System are equivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Precision Spline considers the Reform Pedicle Screw System and Reform HA CoatedPedicle Screw System to be equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in principles of operation, technology,materials, and mechanical testing.

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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.